Official Title
Control of Periodontal Infections
Phase
Phase 3Lead Sponsor
The Forsyth InstituteStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
PeriodontitisIntervention/Treatment
metronidazole procaine benzylpenicillin tetracycline ...Study Participants
187The purpose of this study is to test combined effects of scaling and root planing with periodontal surgery, systemically administered amoxicillin and metronidazole, and/or local tetracycline on pocket depth reduction and attachment level "gain" in patients with chronic periodontitis.
In this 2x2x2 factorial design study, 229 moderate to advanced chronic periodontitis patients stratified according to current smoking status were recruited in USA and Sweden. Patients were randomly assigned to 8 groups, all of which were treated by SRP plus none, one, two or three adjunctive treatments. Thus, patients were assigned to groups that did or did not receive Surg, LAb, SAb or LAb+SAb (All) providing 8 treatment combinations (Surg + All, Surg + SAb, Surg + LAb, Surg alone, SRP + All, SRP + SAb, SRP + LAb, SRP alone). Clinical, microbiological and immunological measurements were taken for 2 years (at baseline, 3, 6, 12, 18 and 24 months). To focus on changes diseased sites, analysis was restricted to sites with baseline pocket depth greater than 5 mm. (also, these were the only sites treated by LAb). In this report, main effects and interactions were evaluated for PD reduction and AL gain two years post therapy for 187 of patients. Mean values were computed for each treatment group and averages after 2 years were compared to baseline by ANOVA. Factorial ANCOVA was used to examine significance of differences between Surg or not, SAb or not and LAb or not for PD reduction and AL gain using baseline attachment level or pocket depth as covariates and including current smoking as a factor.
scaling and root planing as a single therapy
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
periodontal surgery in residual pockets of >4mm
1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
periodontal surgery in residual pockets >4mm, tetracycline ibers releasing approximately 1.7 mg/tooth in pockets >5mm, systemic metronidazlo (250mg tidx14d) and amoxicillin (500 mg bidx14d)
scaling and root planing as a solo therapy
Inclusion Criteria: greater than 20 years of age had a least 15 natural teeth in good general health at least 4 teeth with pockets > 6 mm at least 8 teeth with AL > 3 mm at baseline Exclusion Criteria: pregnant or nursing (if female) having antibiotic or periodontal therapy in the previous three months systemic conditions that would affect the course of periodontal disease systemic conditions that required antibiotic coverage allergic to drugs used in the study
