Control of Periodontal Infections

Phase 3

Completed

• Conditions: Periodontitis
• Interventions: Drug: systemic metronidazole and amoxicillin; Drug: local tetracycline; Other: scaling and root planing; Other: surgery; Drug: local antibiotics and systemic metronidazole and amoxicillin; Other: local tetracycline and periodontal surgery; Other: periodontal surgery and systemic metronidazole and amoxicillin; Other: surgery, local tetracycline, systemic metronidazole and amoxicillin

• Registration Number: NCT01098448
• Lead Sponsor: The Forsyth Institute

Brief 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.

Study Timeline

• Study Start: 1999-09
• Primary Completion: 2004-12
• Study Completion: 2004-12
• Status Verified: 2010-04
• Study First Submitted: 2010-04-01
• Study First Submitted QC: 2010-04-01
• Last Update Submitted: 2010-04-01
• Study First Posted: 2010-04-02
• Last Update Posted: 2010-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
systemic antibiotics	systemic metronidazole and amoxicillin	-
Local delivery of tetracycline	local tetracycline	-
Scaling and root planing	scaling and root planing	scaling and root planing as a solo therapy
Periodontal surgery	surgery	-
local antibiotic and systemic antibiotics	local antibiotics and systemic metronidazole and amoxicillin	-
local antibiotics and surgery	local tetracycline and periodontal surgery	-
systemic antibiotics and surgery	periodontal surgery and systemic metronidazole and amoxicillin	-
local and systemic antibiotics and surgery	surgery, local tetracycline, systemic metronidazole and amoxicillin	-

Primary Outcome Measures

Name	Time	Method
Clinical Attachment Level Gain	24 months

Secondary Outcome Measures

Name	Time	Method
Probing pocket depth reduction	24 months

Trial Locations

Locations (1)

The Forsyth Institute; 🇺🇸 Boston, Massachusetts, United States