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Evaluation of 0.12% chlorhexidine rinse on the prevention of alveolar osteitis
Evaluation of 0.12% chlorhexidine rinse on the prevention of alveolar osteitis James R. Ragno, Jr., LTC, DC, USA,a and Albert J. Szkutnik, Washington, D.C. DENTAL
CLINIC
AND
WALTER
REED
ARMY
MEDICAL
RPh,b Hinesville,
Ga. and
CENTER
A double-blind study evaluated the ability of 0.12% chlorhexidine rinse to decrease the incidence of localized alveolar osteitis after the removal of mandibular third molar teeth. One hundred sixty extraction sites in 80 patients were evaluated. A statistically significant decrease in the incidence of dry socket was seen in patients using the chlorhexidine rinse with no significant adverse reactions. Thus a 0.12% chlorhexidine rinse is shown to be an effective means of decreasing alveolar osteitis that may follow removal of third molar teeth. (ORAL SURG ORAL MED ORAL PATHOL 1991;72:524-6)
R eports in the literature reveal a wide range in the frequency of occurrence of postoperative alveolar osteitis (dry socket) after surgical removal of impacted third molars. The average reported incidence was 25% to 30%.ls4 Many clinical investigations and research have sought to prevent or decrease the problem of dry socket. Swanson5 reviewed the various techniques investigated to reduce the incidence of dry socket. Calhoun6 reviewed those factors said to increase the incidence of alveolar osteitis, including excessive trauma to the bone, inadequate blood supply, mechanical factors such as rinsing or sucking that may cause loss of the clot, foreign bodies or tissue in the socket, and infection. Smoking and the use of birth control pills have also been associated with an increased incidence of dry socket.7 Various techniques have been tried to minimize the effect of each factor believed to be significant. The effect of oral bacteria causing a clot breakdown is thought to be significant, but attempts at control have been mixed. In 1985 Sweet and others8 studied the effect of various iodinated antimicrobial solutions and
The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. VJhief, Oral and Maxillofacial Surgery Service. bChief, Bulk Manufacturing and Investigational Protocols, Walter Reed Army Medical Center. 7/12/30774 524
found they did not decrease the incidence of dry socket. Other investigators have obtained different findings with iodinated solutions. Lilly and others9 studied the use of a phenolated antiseptic mouthrinse (Chloraseptic, Proctor and Gamble, Cincinnati, Ohio) before the extraction of mandibular third molars and reported a decrease in the incidence of dry socket as compared with a control group.9 Hall and others3 found a significant reduction in dry socket with the use of topically applied tetracycline and Gelfoam. This finding was substantiated in work done by Swanson.‘o Rutledge and Marcoot” reported a reduction in dry socket incidence with the insertion of Tera-Cortril into the alveolus; however, cases of myospherulosis developing in the extraction sites have been reported.12 In 1977 Legarth13 studied the effect of 0.2% chlorhexidine on dry socket prevention and noted a 45% decrease in a group of 60 patients. In addition, Tjernberg14 found that only 1 patient in a test group of 30 using 0.2% chlorhexidine rinse had alveolar osteitis as opposed to 5 of 30 patients in the control group. A study by Krekmanov and Nordenram,‘s published in 1986, found an 11% decrease in the incidence of dry socket in patients who rinsed with a 0.2% chlorhexidine solution. This contrasts with results published in 197 1 by Macgregor, l6 who concluded that 0.2% chlorhexidine was not of value as a preoperative antiseptic rinse for oral surgery. In 1990 Brewick and Lessin17 reported a similar finding that chlorhexidine is no more effective than postextraction irrigation
Chlorhexidine rinse and the prevention of alveolar osteitis
Volume 72 Number 5 Table
I. Dry socket rate by surgical site Group
Yes
No
III. Patients in each risk group
Table Total Group
Experimental (0.12% chlorhexidine) Control (placebo)
Table
14
66
80
29 43
51 iii
- 80 160
525
Experimental (0. I2 % chlorhexidine)
1 2 3 4 5 6
0 0 7 7 8 18
Control (placebo)
Total
1 0 8 6 8 17
1 0 15 13 16 35
Control (placebo)
Total
II. Dry socket rate by patient Group
Yes
No
Total
Experimental (0.12% chlorhexidine) Control (placebo)
10
30
48
20 30
20 50
40 80
with normal saline solution in the reduction of alveolar osteitis. This study was carried out to determine whether a 0.12% chlorhexidine solution used as a rinse immediately before and after surgery as well as intraoperatively to irrigate the extraction site could reduce the incidence of alveolar osteitis. MATERIAL
AND METHODS
A double-blind study, reviewed and accepted by the Clinical Investigation Department and the Human Use Committee at Walter Reed Army Medical Center, Washington, D.C., was conducted from July 1987 to April 1989 in the Department of Oral and Maxillofacial Surgery. All patients were screened on a walk-in basis to determine whether they were acceptable subjects. A patient had to be at least 18 years old, have a negative medical history, not be on any medications except birth control pills (BCPs), and have at least two mandibular third molars. Accepted patients were then given a questionnaire to identify their relative risk factors and assigned to one of six risk groups: (1) women who smoke and are not taking BCPs; (2) women who smoke and are taking BCPs; (3) women who do not smoke and are taking BCPs; (4) women not taking BCPs; (5) men who smoke; and (6) men who do not smoke. The patients within each group were randomly assigned to either a control (placebo) or an experimental (0.12% chlorhexidine) group. The pharmacist manufactured the placebo and maintained the code for patient assignments. On the day of surgery, patients first rinsed with 15 ml of a designated solution for 30 seconds. The third molars were then removed with the use of intravenous sedation (fentanyl and midazolam), local anesthesia (0.5% bupivacaine with 1:200,000 epinephrine), and
IV. Dry socket by risk group (patients/extraction site)
Table
Group
1 2 3 4 5 6
Experimental (0.12 % chlorhexidine)
o/o o/o 313 213
213
&
10/14
o/o o/o 517
414 519 & 20/29
o/o o/o 8110 617 7112
standard surgical procedures. All procedures were performed by one resident surgeon with 8 year’s experience in exodontia. After removal of the teeth, the surgical sites were rinsed with 15 ml of the designated solution, and the soft tissue was closed and sutured with 3-O chromic suture. The day after surgery, the patients started home use of the rinse (15 ml for 30 seconds) twice daily for 7 days. A postoperative examination was performed on the third and seventh days to determine any adverse reactions and the presence of alveolar osteitis diagnosed by the presence of a necrotic blood clot or the absence of a blood clot; foul odor; increase in the postoperative pain unrelieved by analgesics; and the absence of clinical signs of gross infection. A postoperative questionnaire was completed on day 7. RESULTS
A total of 80 patients with 160 surgical sites were included in the study. Decoding of the patient assignments revealed 40 patients (80 surgical sites) in both the experimental group and the control group. The overall dry socket rate for the control group, combining all risk groups, was 36% (29/80) of the surgical sites and 50% (20/40) of the patients. The experimental group’s dry socket rate was 17.5% (14/80) of the surgical sites and 25% (10/40) of the patients (Tables I and II). These data were analyzed by a Yates corrected x2. The difference between the con-
626
Ragno and Szkutnik
trol and experimental groups was found to be significant for extraction sites (JJ = 0.008) and for patients treated (p = 0.04). Comparison between control and experimental groups (Tables III and IV) within any individual risk group showed no significant difference; this may be due to the relatively small sample size within each group. There were no allergic reactions or other significant adverse reactions to the 0.12% chlorhexidine. Three patients complained of a “bad taste” from the rinse, and one patient complained of a brief stomach upset. There were no cases of significant staining of the teeth secondary to the rinse. In one patient in the placebo group a severe surgical infection developed 4 days after surgery but was believed unrelated to any medication. DISCUSSION
The data revealed that occurrence of the postoperative complication of alveolar osteitis or “dry socket” can be reduced when patients rinse with 0.12% chlorhexidine immediately before and after surgical removal of third molars. The surgical sites were rinsed with undiluted 0.12% chlorhexidine before closure of the soft tissue. These findings are in direct support of those reported by Legarth,13 Tjernberg,14 and Krekmanov and Nordenram. l5 It was found that a significant reduction in the incidence of dry socket did not require use of the chlorhexidine rinse for an extended period before surgery. No significant adverse reactions were encountered from the use of any medication. Three patients described a “bad taste,” but this did not prevent them from continuing the rinse for the l-week study period. The bad taste can be minimized by instructing patients not to rinse with water for 30 minutes after using the rinse so as to prevent the lossof the flavoring agent and subsequentunmasking of the chlorhexidine. In addition, the use of 0.12% rather than 0.2% chlorhexidine should causefewer adverse taste problems and hasbeen shown to be effective in preventing dry socket. The decrease in the dry socket rate with use of a topical antimicrobial agent further supports the significant role of bacteria in the production of dry socket. The results of this study show that a significant reduction in the incidence of alveolor osteitis can be achieved with useof a 0.12% chlorhexidine solution as
ORAL SURG ORAL MOD ORAL PATHOL November 199 1
an immediate presurgical rinse, irrigation of the extraction site with the undiluted solution, and a 7-day postoperative home rinse program. We thank T.R. Young, Departmentof Clinical Investigations,Walter ReedArmy Medical Center,for hishelpin the statistical analysisof the data. In addition, Leah Higgins’help in scheduling,assistingwith patients,and maintaining patient data recordsis greatly appreciated. REFERENCES
Adkisson SR, Harris PF. Statistical study of alveolar osteitis. USAF Med J 1956;7:1749. Krogh HW. Incidence of dry socket. J Am Dent Assoc 1937;24-36. Hall HD, Bildman BS, Hand CD. Prevention of dry socket with local application of tetracycline. J Oral Surg 1971;20:35. Sorensen DC, Preisch JW. The effect of tetracycline on the incidence of postextraction alveolar osteitis. J Oral Maxillofac Surg 1987;45:1029-33. 5. Swanson AE. Prevention of dry socket: an Overview. ORAL SURG ORAL
MED ORAL PATHOL
1990;70:
13 l-6.
Calhoun NR. Dry socket and other postoperative complications. Dent Clin North Am 1971;15:337-48. I. Sweet JB, Butler DP. Predisposing and operative factors: effect on the incidence of localized osteitis in mandibular third molar surgery. ORAL SURG ORAL MED ORAL PATHOL 1978; 46:206-14. 8. Sweet JB, Macynski RN. Effect of antimicrobial mouth rinses on the incidence of localized alveolitis and infection following mandibular third molar surgery. ORAL SURG ORAL MED ORAL 6.
PATHOL 9.
10.
11. 12. 13. 14. 15. 16. 17.
1985;59:24-6.
Lilly GE, Osbon DB, Rae1 EM, Samuels HS, Jones JC. Alveolar osteitis associated with mandibular third molar extractions. J Am Dent Assoc 1974;88:802-6. Swanson AE. A double-blind study on the effectivenessof tetracycline in reducing the incidence of fibronolytic alveolitis. J Oral Maxillofac Surg 1989;47:165-7. Rutledge JL, Marcoot RM. Terra-Cortril/Gelfoam for reduction of the incidence of localized osteitis following mandibular third molar removal. J Oral Med 1984;39:51-3. Lynch DP, Newland JR. Myospherulosis of oral hard and soft tissues. J Oral Maxillofac Surg 1984;42:349-355. Legarth J. Effect of chlorhexidine on the development of dry socket. ORAL SURG ORAL MED ORAL PATHOL 1977;59:24-6. Tjernberg A. Influence of oral hygiene measures on the development of alveolitis sicca dolorosa after surgical removal of mandibular molars. Int J Oral Maxillofac Surg 1979;8:430-4. Krekmanov L, Nordenram A. Postoperative complications after surgical removal of mandibular third molars. Int J Oral Maxillofac Surg 1986;15:25-9. Macgregor AJ. The topical antiseptic effect of chlorhexidine on the bacteria of third molar wounds and their complications. J Oral Surg 1971;24:481-5. Brewick JE, Lessin ME. Effects of a chlorhexidine gluconate oral rinse on the incidence of alveolar osteitis in mandibular third molar surgery. J Oral Maxillofac Surg 1990;48:444-8.
Reprint
requests:
James R. Ragno Jr. LTC, DC 9 12 Pineland Avenue #17 Hinesville, GA 3 13 13
CLINIC
AND
WALTER
REED
ARMY
MEDICAL
RPh,b Hinesville,
Ga. and
CENTER
A double-blind study evaluated the ability of 0.12% chlorhexidine rinse to decrease the incidence of localized alveolar osteitis after the removal of mandibular third molar teeth. One hundred sixty extraction sites in 80 patients were evaluated. A statistically significant decrease in the incidence of dry socket was seen in patients using the chlorhexidine rinse with no significant adverse reactions. Thus a 0.12% chlorhexidine rinse is shown to be an effective means of decreasing alveolar osteitis that may follow removal of third molar teeth. (ORAL SURG ORAL MED ORAL PATHOL 1991;72:524-6)
R eports in the literature reveal a wide range in the frequency of occurrence of postoperative alveolar osteitis (dry socket) after surgical removal of impacted third molars. The average reported incidence was 25% to 30%.ls4 Many clinical investigations and research have sought to prevent or decrease the problem of dry socket. Swanson5 reviewed the various techniques investigated to reduce the incidence of dry socket. Calhoun6 reviewed those factors said to increase the incidence of alveolar osteitis, including excessive trauma to the bone, inadequate blood supply, mechanical factors such as rinsing or sucking that may cause loss of the clot, foreign bodies or tissue in the socket, and infection. Smoking and the use of birth control pills have also been associated with an increased incidence of dry socket.7 Various techniques have been tried to minimize the effect of each factor believed to be significant. The effect of oral bacteria causing a clot breakdown is thought to be significant, but attempts at control have been mixed. In 1985 Sweet and others8 studied the effect of various iodinated antimicrobial solutions and
The opinions or assertions contained herein are the private views of the authors and are not to be construed as official or as reflecting the views of the Department of the Army or the Department of Defense. VJhief, Oral and Maxillofacial Surgery Service. bChief, Bulk Manufacturing and Investigational Protocols, Walter Reed Army Medical Center. 7/12/30774 524
found they did not decrease the incidence of dry socket. Other investigators have obtained different findings with iodinated solutions. Lilly and others9 studied the use of a phenolated antiseptic mouthrinse (Chloraseptic, Proctor and Gamble, Cincinnati, Ohio) before the extraction of mandibular third molars and reported a decrease in the incidence of dry socket as compared with a control group.9 Hall and others3 found a significant reduction in dry socket with the use of topically applied tetracycline and Gelfoam. This finding was substantiated in work done by Swanson.‘o Rutledge and Marcoot” reported a reduction in dry socket incidence with the insertion of Tera-Cortril into the alveolus; however, cases of myospherulosis developing in the extraction sites have been reported.12 In 1977 Legarth13 studied the effect of 0.2% chlorhexidine on dry socket prevention and noted a 45% decrease in a group of 60 patients. In addition, Tjernberg14 found that only 1 patient in a test group of 30 using 0.2% chlorhexidine rinse had alveolar osteitis as opposed to 5 of 30 patients in the control group. A study by Krekmanov and Nordenram,‘s published in 1986, found an 11% decrease in the incidence of dry socket in patients who rinsed with a 0.2% chlorhexidine solution. This contrasts with results published in 197 1 by Macgregor, l6 who concluded that 0.2% chlorhexidine was not of value as a preoperative antiseptic rinse for oral surgery. In 1990 Brewick and Lessin17 reported a similar finding that chlorhexidine is no more effective than postextraction irrigation
Chlorhexidine rinse and the prevention of alveolar osteitis
Volume 72 Number 5 Table
I. Dry socket rate by surgical site Group
Yes
No
III. Patients in each risk group
Table Total Group
Experimental (0.12% chlorhexidine) Control (placebo)
Table
14
66
80
29 43
51 iii
- 80 160
525
Experimental (0. I2 % chlorhexidine)
1 2 3 4 5 6
0 0 7 7 8 18
Control (placebo)
Total
1 0 8 6 8 17
1 0 15 13 16 35
Control (placebo)
Total
II. Dry socket rate by patient Group
Yes
No
Total
Experimental (0.12% chlorhexidine) Control (placebo)
10
30
48
20 30
20 50
40 80
with normal saline solution in the reduction of alveolar osteitis. This study was carried out to determine whether a 0.12% chlorhexidine solution used as a rinse immediately before and after surgery as well as intraoperatively to irrigate the extraction site could reduce the incidence of alveolar osteitis. MATERIAL
AND METHODS
A double-blind study, reviewed and accepted by the Clinical Investigation Department and the Human Use Committee at Walter Reed Army Medical Center, Washington, D.C., was conducted from July 1987 to April 1989 in the Department of Oral and Maxillofacial Surgery. All patients were screened on a walk-in basis to determine whether they were acceptable subjects. A patient had to be at least 18 years old, have a negative medical history, not be on any medications except birth control pills (BCPs), and have at least two mandibular third molars. Accepted patients were then given a questionnaire to identify their relative risk factors and assigned to one of six risk groups: (1) women who smoke and are not taking BCPs; (2) women who smoke and are taking BCPs; (3) women who do not smoke and are taking BCPs; (4) women not taking BCPs; (5) men who smoke; and (6) men who do not smoke. The patients within each group were randomly assigned to either a control (placebo) or an experimental (0.12% chlorhexidine) group. The pharmacist manufactured the placebo and maintained the code for patient assignments. On the day of surgery, patients first rinsed with 15 ml of a designated solution for 30 seconds. The third molars were then removed with the use of intravenous sedation (fentanyl and midazolam), local anesthesia (0.5% bupivacaine with 1:200,000 epinephrine), and
IV. Dry socket by risk group (patients/extraction site)
Table
Group
1 2 3 4 5 6
Experimental (0.12 % chlorhexidine)
o/o o/o 313 213
213
&
10/14
o/o o/o 517
414 519 & 20/29
o/o o/o 8110 617 7112
standard surgical procedures. All procedures were performed by one resident surgeon with 8 year’s experience in exodontia. After removal of the teeth, the surgical sites were rinsed with 15 ml of the designated solution, and the soft tissue was closed and sutured with 3-O chromic suture. The day after surgery, the patients started home use of the rinse (15 ml for 30 seconds) twice daily for 7 days. A postoperative examination was performed on the third and seventh days to determine any adverse reactions and the presence of alveolar osteitis diagnosed by the presence of a necrotic blood clot or the absence of a blood clot; foul odor; increase in the postoperative pain unrelieved by analgesics; and the absence of clinical signs of gross infection. A postoperative questionnaire was completed on day 7. RESULTS
A total of 80 patients with 160 surgical sites were included in the study. Decoding of the patient assignments revealed 40 patients (80 surgical sites) in both the experimental group and the control group. The overall dry socket rate for the control group, combining all risk groups, was 36% (29/80) of the surgical sites and 50% (20/40) of the patients. The experimental group’s dry socket rate was 17.5% (14/80) of the surgical sites and 25% (10/40) of the patients (Tables I and II). These data were analyzed by a Yates corrected x2. The difference between the con-
626
Ragno and Szkutnik
trol and experimental groups was found to be significant for extraction sites (JJ = 0.008) and for patients treated (p = 0.04). Comparison between control and experimental groups (Tables III and IV) within any individual risk group showed no significant difference; this may be due to the relatively small sample size within each group. There were no allergic reactions or other significant adverse reactions to the 0.12% chlorhexidine. Three patients complained of a “bad taste” from the rinse, and one patient complained of a brief stomach upset. There were no cases of significant staining of the teeth secondary to the rinse. In one patient in the placebo group a severe surgical infection developed 4 days after surgery but was believed unrelated to any medication. DISCUSSION
The data revealed that occurrence of the postoperative complication of alveolar osteitis or “dry socket” can be reduced when patients rinse with 0.12% chlorhexidine immediately before and after surgical removal of third molars. The surgical sites were rinsed with undiluted 0.12% chlorhexidine before closure of the soft tissue. These findings are in direct support of those reported by Legarth,13 Tjernberg,14 and Krekmanov and Nordenram. l5 It was found that a significant reduction in the incidence of dry socket did not require use of the chlorhexidine rinse for an extended period before surgery. No significant adverse reactions were encountered from the use of any medication. Three patients described a “bad taste,” but this did not prevent them from continuing the rinse for the l-week study period. The bad taste can be minimized by instructing patients not to rinse with water for 30 minutes after using the rinse so as to prevent the lossof the flavoring agent and subsequentunmasking of the chlorhexidine. In addition, the use of 0.12% rather than 0.2% chlorhexidine should causefewer adverse taste problems and hasbeen shown to be effective in preventing dry socket. The decrease in the dry socket rate with use of a topical antimicrobial agent further supports the significant role of bacteria in the production of dry socket. The results of this study show that a significant reduction in the incidence of alveolor osteitis can be achieved with useof a 0.12% chlorhexidine solution as
ORAL SURG ORAL MOD ORAL PATHOL November 199 1
an immediate presurgical rinse, irrigation of the extraction site with the undiluted solution, and a 7-day postoperative home rinse program. We thank T.R. Young, Departmentof Clinical Investigations,Walter ReedArmy Medical Center,for hishelpin the statistical analysisof the data. In addition, Leah Higgins’help in scheduling,assistingwith patients,and maintaining patient data recordsis greatly appreciated. REFERENCES
Adkisson SR, Harris PF. Statistical study of alveolar osteitis. USAF Med J 1956;7:1749. Krogh HW. Incidence of dry socket. J Am Dent Assoc 1937;24-36. Hall HD, Bildman BS, Hand CD. Prevention of dry socket with local application of tetracycline. J Oral Surg 1971;20:35. Sorensen DC, Preisch JW. The effect of tetracycline on the incidence of postextraction alveolar osteitis. J Oral Maxillofac Surg 1987;45:1029-33. 5. Swanson AE. Prevention of dry socket: an Overview. ORAL SURG ORAL
MED ORAL PATHOL
1990;70:
13 l-6.
Calhoun NR. Dry socket and other postoperative complications. Dent Clin North Am 1971;15:337-48. I. Sweet JB, Butler DP. Predisposing and operative factors: effect on the incidence of localized osteitis in mandibular third molar surgery. ORAL SURG ORAL MED ORAL PATHOL 1978; 46:206-14. 8. Sweet JB, Macynski RN. Effect of antimicrobial mouth rinses on the incidence of localized alveolitis and infection following mandibular third molar surgery. ORAL SURG ORAL MED ORAL 6.
PATHOL 9.
10.
11. 12. 13. 14. 15. 16. 17.
1985;59:24-6.
Lilly GE, Osbon DB, Rae1 EM, Samuels HS, Jones JC. Alveolar osteitis associated with mandibular third molar extractions. J Am Dent Assoc 1974;88:802-6. Swanson AE. A double-blind study on the effectivenessof tetracycline in reducing the incidence of fibronolytic alveolitis. J Oral Maxillofac Surg 1989;47:165-7. Rutledge JL, Marcoot RM. Terra-Cortril/Gelfoam for reduction of the incidence of localized osteitis following mandibular third molar removal. J Oral Med 1984;39:51-3. Lynch DP, Newland JR. Myospherulosis of oral hard and soft tissues. J Oral Maxillofac Surg 1984;42:349-355. Legarth J. Effect of chlorhexidine on the development of dry socket. ORAL SURG ORAL MED ORAL PATHOL 1977;59:24-6. Tjernberg A. Influence of oral hygiene measures on the development of alveolitis sicca dolorosa after surgical removal of mandibular molars. Int J Oral Maxillofac Surg 1979;8:430-4. Krekmanov L, Nordenram A. Postoperative complications after surgical removal of mandibular third molars. Int J Oral Maxillofac Surg 1986;15:25-9. Macgregor AJ. The topical antiseptic effect of chlorhexidine on the bacteria of third molar wounds and their complications. J Oral Surg 1971;24:481-5. Brewick JE, Lessin ME. Effects of a chlorhexidine gluconate oral rinse on the incidence of alveolar osteitis in mandibular third molar surgery. J Oral Maxillofac Surg 1990;48:444-8.
Reprint
requests:
James R. Ragno Jr. LTC, DC 9 12 Pineland Avenue #17 Hinesville, GA 3 13 13