Control of Periodontal Infections

Periodontitis Clinical Trial

Official title:

Control of Periodontal Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01098448
• Other study ID #: NIDCR-012861
• Status: Completed
• Phase: Phase 3
• First received: April 1, 2010
• Last updated: April 1, 2010
• Start date: September 1999
• Est. completion date: December 2004

Study information

• Verified date: April 2010
• Source: The Forsyth Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardSweden: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: December 2004
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Locations

Country	Name	City	State
United States	The Forsyth Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
The Forsyth Institute	Boston University, Göteborg University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Attachment Level Gain		24 months	No
Secondary	Probing pocket depth reduction		24 months	No