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Locally delivered minocycline in adjunctive to scaling and root planing (SRP) is more effective in mean pocket depth reduction than SRP alone in treating smokers with chronic periodontitis
THERAPY
A RTICLE A NALYSIS & E VALUATION Original Article
Level of Evidence
Question
Source of Funding
Design
Locally delivered minocycline in adjunctive to scaling and root planing (SRP) is more effective in mean pocket depth reduction than SRP alone in treating smokers with chronic periodontitis Paquette D, Oringer R, Lessem J, Offenbacher S, Genco R, Persson GR, Santucci EA, Williams RC. Locally delivered minocycline microspheres for the treatment of periodontitis in smokers. J Clin Periodontol 2003;30(9):787Q94.
1b
Is minocycline microspheres in conjunction with scaling & root planing (SRP) more effective in periodontal therapy in smokers than SRP alone? Information not available
Randomized single-blinded clinical trial
Summary SUBJECTS A total of 271 smokers (aged z30 years) with chronic periodontitis were recruited from 18 centers. Smokers were identified by self-reporting use of tobacco products within the last 6 months. Patients with periodontitis were identified as having at least 4 teeth with 6 to 9 mm probing depths with bleeding on probing. The majority of the subjects were male (56.1%) and Caucasian (81.2%).
J Evid Base Dent Pract 2004;4:218-9 D 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2004.07.018
218
THERAPY All subjects were treated by scaling and root planing (SRP). Then each subject was randomly assigned into 1 out of 3 treatment groups, ie, no further treatment (SRP alone), vehicle control (SRP plus vehicle), and test (SRP plus minocycline microspheres). Vehicle or minocycline was administered into every 5+ mm pocket at baseline, and then re-applied into the same pockets at 3 and 6 months. No additional SRP was performed in any group through the period of the study. The total of the study length was 9 months.
MAIN OUTCOME MEASURE Mean probing pocket depths were calculated from all probing depths measured at 6 sites/tooth using North Carolina #15 probe (rounded down to the nearest millimeter). MAIN RESULTS At 1 month, pocket depth reduction in test group (1.11 mm) was significantly greater than those in control and vehicle control (0.92 mm). However, at 3 months, the differences in pocket depth reductions between groups became statistically insignificant. With the readministration of medications at 3 and 6 months, the differences in pocket depth reduction among groups reached statistical significance again at 6 and 9 months. The mean difference between test and control groups was 0.28 mm at 9 months. CONCLUSIONS The authors concluded that local delivery minocycline microspheres in adjunctive to SRP were more effective in pocket depth reduction than SRP alone in smokers with chronic periodontitis.
Commentary and Analysis This multi-center randomized single-blinded clinical trial was conducted in 18 centers. The obvious benefit of a multi-center study is the diversity of population, thus one might generalize the results from the study to general population. However, with a total of 271 subjects in 18 centers, the number of subjects in each center might be only less than 15 patients, ie, 5 subjects in each group. This small number of patients from each center may not be sufficient to represent the population in each region. The majority of the subjects in this study was Caucasian (81.2%), thus the results from this study can be applied to this group more than other ethnic groups. Though the mean differences in pocket reduction among groups were statistically significant, one must realize the diminished clinically significant difference
Journal of Evidence-Based Dental Practice Volume 4, Number 3
between groups (0.28 mm). Moreover, there were no statistically significant differences in changes of clinical attachment level among groups. There were many advantages of the design of this clinical trial. Each patient received SRP at baseline with no restriction in time or use of local anesthetic. It might be expected that all root surfaces were well cleaned. The blinded examiners and randomization strongly decreased the bias toward groups. The intra-class coefficients were high (ranged from 0.81 to 0.98). However, there were no inter-class coefficients reported, assuming there was no calibration of the examiners among 18 centers. Because the data were pulled together in statistical analysis, it is doubtful that the un-calibrated examiners would affect the differences showed in this study. The analysis based on intent-to-treat population was also the advantage of this study. The major drawback of the design of this study was the inequity of treatment between groups during the maintenance period. In the control group, there was no further treatment after the original SRP at baseline. In contrast, the test group received minocycline micropheres application at baseline, 3 months, and 6 months. Thus, this design favored the test group to both control groups. The effect of this bias was noticeable in the results at 1 and 3 months. The differences in pocket reduction at 1 month were statistically significant. The differences became insignificant at 3 months. After readministration of the medication, the test group returned to be superior to the control groups at 6 and 9 months. It would have been more convincing if the control group received SRP during the maintenance period as well. In summary, the conclusion of the significant benefit of using minocycline micropheres in adjunctive to SRP in treatment of periodontitis in smokers was still questionable. Reviewer: Dr. Pintippa Bunyaratavej Chiang Mai University Faculty of Dentistry Department of Periodontology
Paquette et al 219
A RTICLE A NALYSIS & E VALUATION Original Article
Level of Evidence
Question
Source of Funding
Design
Locally delivered minocycline in adjunctive to scaling and root planing (SRP) is more effective in mean pocket depth reduction than SRP alone in treating smokers with chronic periodontitis Paquette D, Oringer R, Lessem J, Offenbacher S, Genco R, Persson GR, Santucci EA, Williams RC. Locally delivered minocycline microspheres for the treatment of periodontitis in smokers. J Clin Periodontol 2003;30(9):787Q94.
1b
Is minocycline microspheres in conjunction with scaling & root planing (SRP) more effective in periodontal therapy in smokers than SRP alone? Information not available
Randomized single-blinded clinical trial
Summary SUBJECTS A total of 271 smokers (aged z30 years) with chronic periodontitis were recruited from 18 centers. Smokers were identified by self-reporting use of tobacco products within the last 6 months. Patients with periodontitis were identified as having at least 4 teeth with 6 to 9 mm probing depths with bleeding on probing. The majority of the subjects were male (56.1%) and Caucasian (81.2%).
J Evid Base Dent Pract 2004;4:218-9 D 2004 Elsevier Inc. All rights reserved. doi:10.1016/j.jebdp.2004.07.018
218
THERAPY All subjects were treated by scaling and root planing (SRP). Then each subject was randomly assigned into 1 out of 3 treatment groups, ie, no further treatment (SRP alone), vehicle control (SRP plus vehicle), and test (SRP plus minocycline microspheres). Vehicle or minocycline was administered into every 5+ mm pocket at baseline, and then re-applied into the same pockets at 3 and 6 months. No additional SRP was performed in any group through the period of the study. The total of the study length was 9 months.
MAIN OUTCOME MEASURE Mean probing pocket depths were calculated from all probing depths measured at 6 sites/tooth using North Carolina #15 probe (rounded down to the nearest millimeter). MAIN RESULTS At 1 month, pocket depth reduction in test group (1.11 mm) was significantly greater than those in control and vehicle control (0.92 mm). However, at 3 months, the differences in pocket depth reductions between groups became statistically insignificant. With the readministration of medications at 3 and 6 months, the differences in pocket depth reduction among groups reached statistical significance again at 6 and 9 months. The mean difference between test and control groups was 0.28 mm at 9 months. CONCLUSIONS The authors concluded that local delivery minocycline microspheres in adjunctive to SRP were more effective in pocket depth reduction than SRP alone in smokers with chronic periodontitis.
Commentary and Analysis This multi-center randomized single-blinded clinical trial was conducted in 18 centers. The obvious benefit of a multi-center study is the diversity of population, thus one might generalize the results from the study to general population. However, with a total of 271 subjects in 18 centers, the number of subjects in each center might be only less than 15 patients, ie, 5 subjects in each group. This small number of patients from each center may not be sufficient to represent the population in each region. The majority of the subjects in this study was Caucasian (81.2%), thus the results from this study can be applied to this group more than other ethnic groups. Though the mean differences in pocket reduction among groups were statistically significant, one must realize the diminished clinically significant difference
Journal of Evidence-Based Dental Practice Volume 4, Number 3
between groups (0.28 mm). Moreover, there were no statistically significant differences in changes of clinical attachment level among groups. There were many advantages of the design of this clinical trial. Each patient received SRP at baseline with no restriction in time or use of local anesthetic. It might be expected that all root surfaces were well cleaned. The blinded examiners and randomization strongly decreased the bias toward groups. The intra-class coefficients were high (ranged from 0.81 to 0.98). However, there were no inter-class coefficients reported, assuming there was no calibration of the examiners among 18 centers. Because the data were pulled together in statistical analysis, it is doubtful that the un-calibrated examiners would affect the differences showed in this study. The analysis based on intent-to-treat population was also the advantage of this study. The major drawback of the design of this study was the inequity of treatment between groups during the maintenance period. In the control group, there was no further treatment after the original SRP at baseline. In contrast, the test group received minocycline micropheres application at baseline, 3 months, and 6 months. Thus, this design favored the test group to both control groups. The effect of this bias was noticeable in the results at 1 and 3 months. The differences in pocket reduction at 1 month were statistically significant. The differences became insignificant at 3 months. After readministration of the medication, the test group returned to be superior to the control groups at 6 and 9 months. It would have been more convincing if the control group received SRP during the maintenance period as well. In summary, the conclusion of the significant benefit of using minocycline micropheres in adjunctive to SRP in treatment of periodontitis in smokers was still questionable. Reviewer: Dr. Pintippa Bunyaratavej Chiang Mai University Faculty of Dentistry Department of Periodontology
Paquette et al 219