Control of Periodontal Infections

NCT ID: NCT01098448

Last Updated: 2010-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 187 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-09-30
• Study Completion Date: 2004-12-31

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.

Conditions

Periodontitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scaling and root planing

scaling and root planing as a solo therapy

Group Type: ACTIVE_COMPARATOR

scaling and root planing

Intervention Type: OTHER

scaling and root planing as a single therapy

Periodontal surgery

Group Type: EXPERIMENTAL

surgery

Intervention Type: OTHER

periodontal surgery in residual pockets of \>4mm

systemic antibiotics

Group Type: EXPERIMENTAL

systemic metronidazole and amoxicillin

Intervention Type: DRUG

systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14

Local delivery of tetracycline

Group Type: EXPERIMENTAL

local tetracycline

Intervention Type: DRUG

local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm

local antibiotic and systemic antibiotics

Group Type: EXPERIMENTAL

local antibiotics and systemic metronidazole and amoxicillin

Intervention Type: DRUG

1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)

local antibiotics and surgery

Group Type: EXPERIMENTAL

local tetracycline and periodontal surgery

Intervention Type: OTHER

local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm and periodontal surgery in residual pockets of \>4mm

systemic antibiotics and surgery

Group Type: EXPERIMENTAL

periodontal surgery and systemic metronidazole and amoxicillin

Intervention Type: OTHER

surgery in residual pockets \>4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)

local and systemic antibiotics and surgery

Group Type: EXPERIMENTAL

surgery, local tetracycline, systemic metronidazole and amoxicillin

Intervention Type: OTHER

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)

Interventions

scaling and root planing

scaling and root planing as a single therapy

Intervention Type: OTHER

local tetracycline

local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets \>5mm

Intervention Type: DRUG

systemic metronidazole and amoxicillin

systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14

Intervention Type: DRUG

surgery

periodontal surgery in residual pockets of \>4mm

Intervention Type: OTHER

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)

Intervention Type: DRUG

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

Intervention Type: OTHER

periodontal surgery and systemic metronidazole and amoxicillin

surgery in residual pockets \>4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)

Intervention Type: 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)

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Boston University

OTHER

Sponsor Role: collaborator

The Forsyth Institute

OTHER

Sponsor Role: lead

Responsible Party

The Forsyth Institute

Principal Investigators

J Max Goodson, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

The Forsyth Institute

Anne D Haffajee, BDS

Role: PRINCIPAL_INVESTIGATOR

The Forsyth Institute

Locations

The Forsyth Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

NIDCR-012861

Identifier Type: -

Identifier Source: org_study_id