NCT01098448

Control of Periodontal Infections

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 187 (actual)
• Sponsor: The Forsyth Institute · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The 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.

Detailed description

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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
OTHER	scaling and root planing	scaling and root planing as a single therapy
DRUG	local tetracycline	local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm
DRUG	systemic metronidazole and amoxicillin	systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
OTHER	surgery	periodontal surgery in residual pockets of \>4mm
DRUG	local antibiotics and systemic metronidazole and amoxicillin	1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
OTHER	local tetracycline and periodontal surgery	local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm and periodontal surgery in residual pockets of \>4mm
OTHER	periodontal surgery and systemic metronidazole and amoxicillin	surgery in residual pockets \>4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
OTHER	surgery, local tetracycline, systemic metronidazole and amoxicillin	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)

Timeline

• Start date: 1999-09-01
• Primary completion: 2004-12-01
• Completion: 2004-12-01
• First posted: 2010-04-02
• Last updated: 2010-04-02

Locations

1 site across 1 country: United States