- Email: [email protected]
Comparison of Enamel Matrix Derivative Versus Formocresol as Pulpotomy Agents in the Primary Dentition
Clinical Research
Comparison of Enamel Matrix Derivative Versus Formocresol as Pulpotomy Agents in the Primary Dentition Jumana Sabbarini, BDS, MSc,* Ahmed Mohamed, BDS, MSc, PhD,† Nadia Wahba, BDS, MSc, PhD,† Omar El-Meligy, BDS, MSc, PhD,† and Jeffrey Dean, DDS, MSD‡ Abstract The purpose of this study was to compare the clinical and radiographic success rates of two different pulpotomy agents: one novel agent, the biologically active odontogenic protein enamel matrix derivative (EMD) versus formocresol (FC). A randomized, single-blind, split-mouth study was used with a sample of 15 children aged 4 to 7 years (mean age, 5 ⫾ 0.73 years). A total of 15 pairs of teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the EMD pulpotomy group or the FC pulpotomy group. All teeth were followed up clinically and radiographically at 2, 4, and 6 months. After 6 months, the clinical success rates for the FC and EMD groups were 67% and 93%, respectively. Although most likely clinically relevant, the clinical success rate difference after 6 months was not statistically significant. After 6 months, the radiographic success rates for the FC and EMD groups were 13% and 60 %, respectively. There was a statistically significant difference at p ⱕ 0.05. The clinical and radiographic assessment of EMD pulpotomized teeth in this study offers preliminary evidence that EMD is a promising material which may be as successful, or more so, than other pulpotomy agents. (J Endod 2008;34:284 –287)
Key Words Emdogain, formocresol, primary dentition, pulpotomy
From the *Ministry of Health, Irbid, Jordan; †Alexandria University Faculty of Dentistry, Alexandria, Egypt; and ‡Indiana University School of Dentistry, Indianapolis, Indiana. Address requests for reprints to Dr. Jumana Sabbarini, Ministry of Health, Irbid Health Department, Irbid, Jordan. E-mail address: [email protected]. 0099-2399/$0 - see front matter Copyright © 2008 by the American Association of Endodontists. doi:10.1016/j.joen.2007.12.002
284
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C
aries, trauma, and clinical procedures can all cause exposure of vital pulp tissue that severely hampers the function and lifespan of the tooth. Pulpotomy of the primary tooth is not only the most frequent endodontic treatment performed on children but also the most controversial. The technique is based on amputation of the pulp chamber and conservation of inflammation-free root canals. Depending on the materials used, the clinical results can be good. In this regard, formocresol (FC) remains the standard, even though its clinical toxicity remains a concern (1). Many investigations have been conducted to measure the risk of exposure to FC because it possesses possible toxic mutagenic and carcinogenic risks in humans (2). It is systemically absorbed and distributed and will initiate a specific humoral response.. In addition, it can have an effect on the succedaneous teeth, such as hypoplastic and/or hypomineralization defects (3).. It may also cause necrosis and sloughing of tissues if it touches the gingiva (4). Furthermore, a relation between FC pulpotomy and dentigerous cyst was detected (5). Recently, a number of studies have reported that various odontogenic proteins can induce reparative dentine formation. Biologically active molecules, such as bone morphogenic proteins (6), osteogenic proteins (7), or biometrics, such as demineralized dentine (8), have all been proposed as specific bioinducers of dentine formation. When these substances are brought in close contact with vital pulp tissue, they enhance the normal sequence of morphogenic events in the repairing dental pulp (ie, rapid fibrodentine matrix formation and subsequent reparative dentinogenesis). However, in some of the previously mentioned studies, the cavities were double sealed with an adhesive resin-based system before final cavity restoration, making it difficult to separate the effect(s) of the biological treatment from the advantageous effect of proper cavity sealing (6, 8). Furthermore, none of the biomaterials\proteins tested so far are commercially available nor have their safety and toxicity aspects been properly assessed for use in clinical trials. Enamel matrix proteins like amelogenins from the preameloblasts are translocated during odontogenesis to differentiating odontoblasts in the dental papilla, suggesting that amelogenins may be associated with odontoblast changes during development (9). Enamel matrix derivative (EMD), obtained from embryonic enamel of amelogenin, has been shown in vitro (using a wound-healing model) to be capable of stimulating periodontal ligament cell proliferation sooner than gingival fibroblasts and bone cells (10). EMD has been successfully used as a pulpotomy agent in noninfected teeth in animal studies (11, 12). On experimentally exposed human pulps, enamel matrix derivative (EMD) gel was used as pulp-capping material. Postoperative symptoms were less frequent in the EMDgel-treated teeth, new tissue partly filled the space initially occupied by the gel, and hard tissue was formed alongside the exposed dentine surfaces and in patches in the adjacent pulp tissue. EMD was detected in the areas in which new hard tissue had been formed (13). However, scarce information is available on its effect on human teeth. Therefore, the present study was performed to compare the clinical and radiographic effect of EMD versus formocresol on pulpotomized human primary teeth.
JOE — Volume 34, Number 3, March 2008
Clinical Research Methods
Results
The subjects selected for this study were children served by the pediatric dental clinics, Department of Pediatric Dentistry, Alexandria University. The Alexandria University Faculty of Dentistry Quality Assurance Committee reviewed and ensured that this research was conducted in a manner that protected the rights and welfare of the human subjects that were involved in this study. A randomized, single-blind, split-mouth study was used with a sample of 15 children aged from 4 to 7 years (mean age, 5 ⫾ 0.73 years) with bilateral deep carious mandibular primary molars who were selected to meet the criteria recommended for a pulpotomy. Teeth were selected with pathological carious exposure of vital pulp, no pain on percussion, absence of tooth mobility, no clinical evidence of pulpal degeneration (eg, draining sinus), and absence of coronal destruction that precludes restorability (14 –16). A recent periapical radiograph was used to rule out radiographic evidence of internal resorption or calcific degeneration in the pulp, evidence of periodontal membrane widening, external or internal root resorption, and periapical or furcation radiolucency. Thirty teeth were selected and randomly divided into 2 treatment groups of 15 teeth each. Group FC had the pulpotomized teeth treated with FC (Buckley’s, Sultan Chemists Inc, Englewood, NJ) on one side of the mandible. Group EMD had the pulpotomized teeth treated with EMD (Emdogain gel; Straumann, Basel, Switzerland) on the contralateral side of the mandible. For patients of both groups, each subject was coded on a special sheet bearing the patient’s name, age, medical and dental history, date of treatment, and successive follow-up records. The pulpotomy technique consisted of the following procedures. After profound local anesthesia, the tooth was isolated with a rubber dam. All dental caries and overhanging enamel were removed, and, when pulpal exposure occurred, a sterile high-speed no. 330 bur was used to remove the roof of the pulp chamber. The coronal pulp tissue was amputated by using a sterile sharp spoon excavator. Gross hemorrhage control was achieved by using a moist cotton pellet for a few minutes. In the group FC, a sterile cotton pellet lightly moistened with 1/5 concentration FC and then blotted to remove the excess was placed against the pulpal stumps for 5 minutes. Cavit base material was placed over the amputated pulp stumps, and then light-cured glass ionomer cement (Vitremer; 3M ESPE, Seefeld, Germany) was applied. In the EMD group, a cotton pellet was placed to cover the amputated pulp stumps, and the tooth was then conditioned with polyacrylic acid gel. The cotton pellet was then removed, and the amputated pulpal stumps were covered with Emdogain gel from a 0.3-mL syringe Light-cured glass ionomer cement (Vitremer) was applied over the gel. For both groups, the interproximal and occlusal surfaces of each treated tooth were then prepared with a no. 69L fissure diamond bur. An appropriate stainless steel crown was cemented by using zinc-polycarboxylate cement. Patients were recalled for evaluation at 2-, 4-, and 6-month intervals. Two examiners who were blinded to treatment type evaluated the teeth clinically and radiographically. The examiners were faculty from the Department of Pediatric Dentistry and Public Health, Alexandria University. The pulpotomy procedure was determined a clinical success if the tooth exhibited an absence of pain, pain on percussion, mobility, and abscess or fistula formation. The pulpotomized teeth were judged a radiographic success if they exhibited a normal periodontal ligament space and had an absence of furcation and periapical radiolucency, pulp calcification, and internal resorption. The clinical and radiographic data for the 2 groups were statistically analyzed by using the McNemar test.
The clinical study consisted of 15 patients with a mean age of 5 ⫾ 0.73 years requiring bilateral pulpotomized mandibular primary molars for clinical and radiographic evaluation. There were 5 females and 10 male patients. The treated teeth comprised 22 lower first primary molars and 8 lower second primary molars. Teeth of both groups were checked clinically 1 week postoperatively. At this time, no pathological signs or symptoms were reported in any of the treated teeth.
JOE — Volume 34, Number 3, March 2008
Clinical Success After 2 months, only one tooth suffered from pain and was sensitive to percussion in the FC group, for a 93.3% clinical success rate (Fig. 1). The clinical success rate dropped to 86.7% at 4 months, and at 6 months five teeth showed pain and pain on percussion, lowering the clinical success rate to 66.7%. The EMD group showed an overall clinical success rate of 100% at 2 and 4 months. Only one tooth presented with pain on percussion at 6 months, reducing the clinical success rate to 93.3%. All teeth were free from mobility, abscess formation, or a draining sinus at 2, 4, and 6 months among both the FC and EMD groups. Radiographic Success In the FC group, 11 teeth (73.3%) showed no pathological signs radiographically at the 2-month recall (Fig. 2). The radiographic success rate was only seen in four teeth (26.7%) at the 4-month recall, and only two teeth (13.3%) were still free of pathology at the 6-month recall. In the EMD group at 2 months, the radiographic success rate was 86.7%, representing 13 radiographically successful teeth. This success rate dropped to 10 teeth (66.7%) at 4 months, and 9 teeth (60%) were free of pathological signs at 6 months. Statistical Analysis No statistically significant differences were noted between any of the groups, except the radiographic success of the FC and EMD groups at the 4-month (p ⫽ 0.03) and the 6-month (p ⫽ 0.04) recall visits.
Discussion Few areas in pediatric dentistry have been as controversial as pulp therapy, particularly the pulpotomy technique. This study was conducted to compare two different modalities of primary tooth pulp treat-
Figure 1. A comparison of the percent of clinically successful cases between Formocresol and Emdogain groups in different follow-up periods.
EMD versus FC as Pulpotomy Agents in Primary Dentition
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Clinical Research
Figure 2. A comparison of the percent of radiographically successful cases between FC and Emdogain groups in different follow-up periods.
ment: FC and EMD, a novel material designed to induce pulp regeneration. FC remains the most popular devitalizing material used in the primary dentition and, therefore, was selected as the control material in
this study. It has long been the standard pulpotomy agent in primary teeth with clinically acceptable success rates (17–22) ranging from 88% to 99%, although lower clinical success rates for FC have been reported to range from 74% to 80%. In the present study, the clinical success rate dropped to 66.7% at the end of the 6 months. One tooth was considered to have failed clinically because of pain on percussion; however, that tooth did not have any radiographic changes. Similarly, some of the teeth considered radiographic failures did not present any negative clinical signs and symptoms through the 6-month follow-up. Because of the small sample size in this study, a difference of one tooth could be significant. It is possible that if the recall periods had continued for a longer period more cases might have started to show clinical or radiographic failures. Furthermore, it has been reported that an 81% agreement between clinical and histologic diagnosis of chronic coronal pulpitis in carious primary teeth exists. A tooth may clinically appear to be a good candidate for a pulpotomy, but pulpal inflammation may not be confined to the coronal portion of the pulp, jeopardizing the success of the procedure. The fixative properties of FC and the possibility of mummifying a broad zone of the remaining pulpal tissue can help a tooth treated with this medicament remain clinically successful (23). EMD (Emdogain) as a pulp tissue regenerative material was selected because of its predictable bioinduction of dentine formation, which would be expected to dramatically change the outcome of pulp therapy. Such healing is a critical issue not only for scientific reasons but also for clinical practice, especially if the associated factors and EMD’s mechanism of action are clarified (11). In this study, the percentage of clinical success of Emdogain was 93.3% at 6 months; only 1 tooth out of 15 was reported to be painful. When compared with FC, EMD appears to
Figure 3. Periapical radiographs of the lower second primary molars of the same patient treated with EMD on the left molar and FC on the right molar at 2 and 6 months postoperatively. (A) EMD and (B) FC both at 2 months showed no radiographic changes. (C) EMD at 6 months showed no radiographic changes. (D) FC at 6 months showed furcal and periapical radiolucency and internal resorption.
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Clinical Research be clinically and radiographically superior. However, a significant disadvantage was the gel consistency of EMD, making its application rather difficult. Moreover, it was impossible to condense any material over it. In addition, although the amount of the gel in the 0.3-mL syringe was enough for five primary molars, it had to be used within 2 hours or it would lose its effect. This meant that any remaining quantity was discarded if not used in the proper time, which greatly reduces the costeffectiveness of the material. The radiographic results were more promising for EMD than FC. The EMD-treated teeth had less periodontal membrane widening in comparison to FC. The same was true for periapical and/or furcation radiolucencies (Figure 3); however, the decrease was not as significant as found when using ferric sulfate (24). Although internal resorption is not considered a radiographic failure by some authors, 20% of the cases in this study showed signs of internal resorption. On the other hand, no pulp calcifications were reported, which might indicate a different pattern of odontoblastic activity for EMD. The clinical and radiographic assessment of EMD pulpotomized teeth in this study offers preliminary evidence that EMD is a promising material that may be as good as or better than other pulpotomy agents. This study was a first step in the clinical use of EMD on human pulpotomized teeth and suggests the need for additional research with a larger sample. Further refinement of the delivery system is needed to ensure that EMD can be developed as an agent for predictable and cost-effective induction of dentine formation in patients.
References 1. Pilipili CM, Vanden Abbeele A, Van den Abbeele K. Pulpotomy of deciduous teeth. Rev Belge Med Dent 2004;59:156 – 62. 2. Lewis B. Formaldehyde in dentistry: a review for the millennium. J Clin Pediatr Dent 1988;22:167–78. 3. Messer LB, Cline JT, Korf NW. Long term effects of primary molar pulpotomies on succedaneous bicuspids. J Dent Res 1980;59:116 –23. 4. Sipes R, Binkley CJ. The use of formocresol in dentistry: a review of literature. Quintessence Int 1986;17:415–7. 5. Asián-González E, Pereira-Maestre M, Conde-Fernández D, Vilchez I, Segura-Egea JJ, Gutiérrez-Pérez JL. Dentigerous cyst associated with a formocresol pulpotomized deciduous molar. J Endod 2007;33:488 –92.
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6. Nakashima M. Induction of dentin formation on canine amputated pulp by recombinant human bone morphogenetic proteins (BMP)-2 and -4. J Dent Res 1994; 73:1515–22. 7. Rutherford RB, Wahle J, Tucker M, Rueger D, Charette M. Induction of reparative dentine formation in monkeys by recombinant human osteogenic protein-1. Arch Oral Biol 1993;38:571– 6. 8. Nakashima M. Dentin induction by implants of autolyzed antigen-extracted allogenic dentin on amputated pulps of dogs. Endod Dent Traumatol 1989;5:279 – 86. 9. Nakamura M, Bringas P Jr, Nanci A, Zeichner-David M, Ashdown B, Slavkin HC. Translocation of enamel proteins from inner enamel epithelia to odontoblasts during mouse tooth development. Anat Rec 1994;238:383–96. 10. Hoang AM, Oates TW, Cochran DL. In vitro wound healing responses to enamel matrix derivative. J Periodontol 2000;71:1270 –7. 11. Nakamura Y, Hammarstrom L, Matsumoto K, Lyngstadaas SP. The induction of reparative dentine by enamel proteins. Int Endod J 2002;35:407–17. 12. Ishizaki NT, Matsumoto K, Kimura Y, Wang X, Yamashita. A histopathological study of dental pulp tissue capped with enamel matrix derivative. J Endod 2003;29:176 –9. 13. Olsson H, Davies JR, Holst E, Schroder U, Petersson K. Dental pulp capping: effect of Emdogain Gel on experimentally exposed human pulps. Int Endod J 2005;38: 186 –94. 14. Dean JA, Mack RB, Fulkerson BT, Sanders BJ. Comparison of electrosurgical and formocresol pulpotomy procedures in children. Int J Paediatr Dent 2002;12: 177– 82. 15. Fuks AB, Holan G, Davis JM, Fidelman E. Ferric sulfate versus dilute formocresol in pulpotomized primary molars: long-term follow up. Pediatr Dent 1997;19:327–30. 16. Fadavi S, Anderson AW. A comparison of the pulpal response to freeze-dried bone, calcium hydroxide, and zinc oxide-eugenol in primary teeth in two cynomolgus monkeys. Pediatr Dent 1996;18:52– 6. 17. Judd PL, Kenny DJ. Formocresol concerns. A review. J Can Dent Assoc 1987;53:401– 4. 18. Fuks AB, Bimstein E. Clinical evaluation of diluted formocresol pulpotomies in primary teeth of school children. Pediatr Dent 1981;3:321– 4. 19. Heilig J, Yates J, Siskin M, McKnight J, Turner J. Calcium hydroxide pulpotomy for primary teeth: a clinical study. J Am Dent Assoc 1984;108:775– 8. 20. Hicks MJ, Barr ES, Flaitz CM. Formocresol pulpotomies in primary molars: a radiographic study in pediatric dentistry. J Pedod 1986;10:331–9. 21. Fei A, Udin RD, Johanson R. A clinical study of ferric sulfate as a pulpotomy agent in primary teeth. Pediatr Dent 1991;13:327–32. 22. Roberts JF. Treatment of vital and non-vital primary molar teeth by one-stage formocresol pulpotomy: clinical success and effect upon age at exfoliation. Int J Paediatr Dent 1996;6:111–5. 23. Schroder U. Agreement between clinical and histologic findings in chronic coronal pulpitis in primary teeth. Scand J Dent Res 1977;85:583–7. 24. Smith NL, Seale NS, Nunn ME. Ferric sulfate pulpotomy in primary molars: a retrospective study. Pediatr Dent 2000;22:192–9.
EMD versus FC as Pulpotomy Agents in Primary Dentition
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Comparison of Enamel Matrix Derivative Versus Formocresol as Pulpotomy Agents in the Primary Dentition Jumana Sabbarini, BDS, MSc,* Ahmed Mohamed, BDS, MSc, PhD,† Nadia Wahba, BDS, MSc, PhD,† Omar El-Meligy, BDS, MSc, PhD,† and Jeffrey Dean, DDS, MSD‡ Abstract The purpose of this study was to compare the clinical and radiographic success rates of two different pulpotomy agents: one novel agent, the biologically active odontogenic protein enamel matrix derivative (EMD) versus formocresol (FC). A randomized, single-blind, split-mouth study was used with a sample of 15 children aged 4 to 7 years (mean age, 5 ⫾ 0.73 years). A total of 15 pairs of teeth, 1 pair per child, were selected for treatment. One tooth from each pair was randomly assigned to either the EMD pulpotomy group or the FC pulpotomy group. All teeth were followed up clinically and radiographically at 2, 4, and 6 months. After 6 months, the clinical success rates for the FC and EMD groups were 67% and 93%, respectively. Although most likely clinically relevant, the clinical success rate difference after 6 months was not statistically significant. After 6 months, the radiographic success rates for the FC and EMD groups were 13% and 60 %, respectively. There was a statistically significant difference at p ⱕ 0.05. The clinical and radiographic assessment of EMD pulpotomized teeth in this study offers preliminary evidence that EMD is a promising material which may be as successful, or more so, than other pulpotomy agents. (J Endod 2008;34:284 –287)
Key Words Emdogain, formocresol, primary dentition, pulpotomy
From the *Ministry of Health, Irbid, Jordan; †Alexandria University Faculty of Dentistry, Alexandria, Egypt; and ‡Indiana University School of Dentistry, Indianapolis, Indiana. Address requests for reprints to Dr. Jumana Sabbarini, Ministry of Health, Irbid Health Department, Irbid, Jordan. E-mail address: [email protected]. 0099-2399/$0 - see front matter Copyright © 2008 by the American Association of Endodontists. doi:10.1016/j.joen.2007.12.002
284
Sabbarini et al.
C
aries, trauma, and clinical procedures can all cause exposure of vital pulp tissue that severely hampers the function and lifespan of the tooth. Pulpotomy of the primary tooth is not only the most frequent endodontic treatment performed on children but also the most controversial. The technique is based on amputation of the pulp chamber and conservation of inflammation-free root canals. Depending on the materials used, the clinical results can be good. In this regard, formocresol (FC) remains the standard, even though its clinical toxicity remains a concern (1). Many investigations have been conducted to measure the risk of exposure to FC because it possesses possible toxic mutagenic and carcinogenic risks in humans (2). It is systemically absorbed and distributed and will initiate a specific humoral response.. In addition, it can have an effect on the succedaneous teeth, such as hypoplastic and/or hypomineralization defects (3).. It may also cause necrosis and sloughing of tissues if it touches the gingiva (4). Furthermore, a relation between FC pulpotomy and dentigerous cyst was detected (5). Recently, a number of studies have reported that various odontogenic proteins can induce reparative dentine formation. Biologically active molecules, such as bone morphogenic proteins (6), osteogenic proteins (7), or biometrics, such as demineralized dentine (8), have all been proposed as specific bioinducers of dentine formation. When these substances are brought in close contact with vital pulp tissue, they enhance the normal sequence of morphogenic events in the repairing dental pulp (ie, rapid fibrodentine matrix formation and subsequent reparative dentinogenesis). However, in some of the previously mentioned studies, the cavities were double sealed with an adhesive resin-based system before final cavity restoration, making it difficult to separate the effect(s) of the biological treatment from the advantageous effect of proper cavity sealing (6, 8). Furthermore, none of the biomaterials\proteins tested so far are commercially available nor have their safety and toxicity aspects been properly assessed for use in clinical trials. Enamel matrix proteins like amelogenins from the preameloblasts are translocated during odontogenesis to differentiating odontoblasts in the dental papilla, suggesting that amelogenins may be associated with odontoblast changes during development (9). Enamel matrix derivative (EMD), obtained from embryonic enamel of amelogenin, has been shown in vitro (using a wound-healing model) to be capable of stimulating periodontal ligament cell proliferation sooner than gingival fibroblasts and bone cells (10). EMD has been successfully used as a pulpotomy agent in noninfected teeth in animal studies (11, 12). On experimentally exposed human pulps, enamel matrix derivative (EMD) gel was used as pulp-capping material. Postoperative symptoms were less frequent in the EMDgel-treated teeth, new tissue partly filled the space initially occupied by the gel, and hard tissue was formed alongside the exposed dentine surfaces and in patches in the adjacent pulp tissue. EMD was detected in the areas in which new hard tissue had been formed (13). However, scarce information is available on its effect on human teeth. Therefore, the present study was performed to compare the clinical and radiographic effect of EMD versus formocresol on pulpotomized human primary teeth.
JOE — Volume 34, Number 3, March 2008
Clinical Research Methods
Results
The subjects selected for this study were children served by the pediatric dental clinics, Department of Pediatric Dentistry, Alexandria University. The Alexandria University Faculty of Dentistry Quality Assurance Committee reviewed and ensured that this research was conducted in a manner that protected the rights and welfare of the human subjects that were involved in this study. A randomized, single-blind, split-mouth study was used with a sample of 15 children aged from 4 to 7 years (mean age, 5 ⫾ 0.73 years) with bilateral deep carious mandibular primary molars who were selected to meet the criteria recommended for a pulpotomy. Teeth were selected with pathological carious exposure of vital pulp, no pain on percussion, absence of tooth mobility, no clinical evidence of pulpal degeneration (eg, draining sinus), and absence of coronal destruction that precludes restorability (14 –16). A recent periapical radiograph was used to rule out radiographic evidence of internal resorption or calcific degeneration in the pulp, evidence of periodontal membrane widening, external or internal root resorption, and periapical or furcation radiolucency. Thirty teeth were selected and randomly divided into 2 treatment groups of 15 teeth each. Group FC had the pulpotomized teeth treated with FC (Buckley’s, Sultan Chemists Inc, Englewood, NJ) on one side of the mandible. Group EMD had the pulpotomized teeth treated with EMD (Emdogain gel; Straumann, Basel, Switzerland) on the contralateral side of the mandible. For patients of both groups, each subject was coded on a special sheet bearing the patient’s name, age, medical and dental history, date of treatment, and successive follow-up records. The pulpotomy technique consisted of the following procedures. After profound local anesthesia, the tooth was isolated with a rubber dam. All dental caries and overhanging enamel were removed, and, when pulpal exposure occurred, a sterile high-speed no. 330 bur was used to remove the roof of the pulp chamber. The coronal pulp tissue was amputated by using a sterile sharp spoon excavator. Gross hemorrhage control was achieved by using a moist cotton pellet for a few minutes. In the group FC, a sterile cotton pellet lightly moistened with 1/5 concentration FC and then blotted to remove the excess was placed against the pulpal stumps for 5 minutes. Cavit base material was placed over the amputated pulp stumps, and then light-cured glass ionomer cement (Vitremer; 3M ESPE, Seefeld, Germany) was applied. In the EMD group, a cotton pellet was placed to cover the amputated pulp stumps, and the tooth was then conditioned with polyacrylic acid gel. The cotton pellet was then removed, and the amputated pulpal stumps were covered with Emdogain gel from a 0.3-mL syringe Light-cured glass ionomer cement (Vitremer) was applied over the gel. For both groups, the interproximal and occlusal surfaces of each treated tooth were then prepared with a no. 69L fissure diamond bur. An appropriate stainless steel crown was cemented by using zinc-polycarboxylate cement. Patients were recalled for evaluation at 2-, 4-, and 6-month intervals. Two examiners who were blinded to treatment type evaluated the teeth clinically and radiographically. The examiners were faculty from the Department of Pediatric Dentistry and Public Health, Alexandria University. The pulpotomy procedure was determined a clinical success if the tooth exhibited an absence of pain, pain on percussion, mobility, and abscess or fistula formation. The pulpotomized teeth were judged a radiographic success if they exhibited a normal periodontal ligament space and had an absence of furcation and periapical radiolucency, pulp calcification, and internal resorption. The clinical and radiographic data for the 2 groups were statistically analyzed by using the McNemar test.
The clinical study consisted of 15 patients with a mean age of 5 ⫾ 0.73 years requiring bilateral pulpotomized mandibular primary molars for clinical and radiographic evaluation. There were 5 females and 10 male patients. The treated teeth comprised 22 lower first primary molars and 8 lower second primary molars. Teeth of both groups were checked clinically 1 week postoperatively. At this time, no pathological signs or symptoms were reported in any of the treated teeth.
JOE — Volume 34, Number 3, March 2008
Clinical Success After 2 months, only one tooth suffered from pain and was sensitive to percussion in the FC group, for a 93.3% clinical success rate (Fig. 1). The clinical success rate dropped to 86.7% at 4 months, and at 6 months five teeth showed pain and pain on percussion, lowering the clinical success rate to 66.7%. The EMD group showed an overall clinical success rate of 100% at 2 and 4 months. Only one tooth presented with pain on percussion at 6 months, reducing the clinical success rate to 93.3%. All teeth were free from mobility, abscess formation, or a draining sinus at 2, 4, and 6 months among both the FC and EMD groups. Radiographic Success In the FC group, 11 teeth (73.3%) showed no pathological signs radiographically at the 2-month recall (Fig. 2). The radiographic success rate was only seen in four teeth (26.7%) at the 4-month recall, and only two teeth (13.3%) were still free of pathology at the 6-month recall. In the EMD group at 2 months, the radiographic success rate was 86.7%, representing 13 radiographically successful teeth. This success rate dropped to 10 teeth (66.7%) at 4 months, and 9 teeth (60%) were free of pathological signs at 6 months. Statistical Analysis No statistically significant differences were noted between any of the groups, except the radiographic success of the FC and EMD groups at the 4-month (p ⫽ 0.03) and the 6-month (p ⫽ 0.04) recall visits.
Discussion Few areas in pediatric dentistry have been as controversial as pulp therapy, particularly the pulpotomy technique. This study was conducted to compare two different modalities of primary tooth pulp treat-
Figure 1. A comparison of the percent of clinically successful cases between Formocresol and Emdogain groups in different follow-up periods.
EMD versus FC as Pulpotomy Agents in Primary Dentition
285
Clinical Research
Figure 2. A comparison of the percent of radiographically successful cases between FC and Emdogain groups in different follow-up periods.
ment: FC and EMD, a novel material designed to induce pulp regeneration. FC remains the most popular devitalizing material used in the primary dentition and, therefore, was selected as the control material in
this study. It has long been the standard pulpotomy agent in primary teeth with clinically acceptable success rates (17–22) ranging from 88% to 99%, although lower clinical success rates for FC have been reported to range from 74% to 80%. In the present study, the clinical success rate dropped to 66.7% at the end of the 6 months. One tooth was considered to have failed clinically because of pain on percussion; however, that tooth did not have any radiographic changes. Similarly, some of the teeth considered radiographic failures did not present any negative clinical signs and symptoms through the 6-month follow-up. Because of the small sample size in this study, a difference of one tooth could be significant. It is possible that if the recall periods had continued for a longer period more cases might have started to show clinical or radiographic failures. Furthermore, it has been reported that an 81% agreement between clinical and histologic diagnosis of chronic coronal pulpitis in carious primary teeth exists. A tooth may clinically appear to be a good candidate for a pulpotomy, but pulpal inflammation may not be confined to the coronal portion of the pulp, jeopardizing the success of the procedure. The fixative properties of FC and the possibility of mummifying a broad zone of the remaining pulpal tissue can help a tooth treated with this medicament remain clinically successful (23). EMD (Emdogain) as a pulp tissue regenerative material was selected because of its predictable bioinduction of dentine formation, which would be expected to dramatically change the outcome of pulp therapy. Such healing is a critical issue not only for scientific reasons but also for clinical practice, especially if the associated factors and EMD’s mechanism of action are clarified (11). In this study, the percentage of clinical success of Emdogain was 93.3% at 6 months; only 1 tooth out of 15 was reported to be painful. When compared with FC, EMD appears to
Figure 3. Periapical radiographs of the lower second primary molars of the same patient treated with EMD on the left molar and FC on the right molar at 2 and 6 months postoperatively. (A) EMD and (B) FC both at 2 months showed no radiographic changes. (C) EMD at 6 months showed no radiographic changes. (D) FC at 6 months showed furcal and periapical radiolucency and internal resorption.
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Sabbarini et al.
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Clinical Research be clinically and radiographically superior. However, a significant disadvantage was the gel consistency of EMD, making its application rather difficult. Moreover, it was impossible to condense any material over it. In addition, although the amount of the gel in the 0.3-mL syringe was enough for five primary molars, it had to be used within 2 hours or it would lose its effect. This meant that any remaining quantity was discarded if not used in the proper time, which greatly reduces the costeffectiveness of the material. The radiographic results were more promising for EMD than FC. The EMD-treated teeth had less periodontal membrane widening in comparison to FC. The same was true for periapical and/or furcation radiolucencies (Figure 3); however, the decrease was not as significant as found when using ferric sulfate (24). Although internal resorption is not considered a radiographic failure by some authors, 20% of the cases in this study showed signs of internal resorption. On the other hand, no pulp calcifications were reported, which might indicate a different pattern of odontoblastic activity for EMD. The clinical and radiographic assessment of EMD pulpotomized teeth in this study offers preliminary evidence that EMD is a promising material that may be as good as or better than other pulpotomy agents. This study was a first step in the clinical use of EMD on human pulpotomized teeth and suggests the need for additional research with a larger sample. Further refinement of the delivery system is needed to ensure that EMD can be developed as an agent for predictable and cost-effective induction of dentine formation in patients.
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