Clinical trial NCT01098448: Control of Periodontal Infections
Official title: Control of Periodontal Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Periodontitis
Keywords: Amoxicillin
antibiotics
chronic periodontitis
local drug delivery
metronidazol
randomized controlled trial
subgingival scaling
surgery
tetracycline
moderate to advanced chronic periodontitis
Lead sponsor: The Forsyth Institute
Sponsor class: OTHER
Collaborators: name: Göteborg University
name: Boston University
First posted: 2010-04-02
Enrollment: 187
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Attachment Level Gain
timeFrame: 24 months
Secondary outcomes:
measure: Probing pocket depth reduction
timeFrame: 24 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: The Forsyth Institute
state: Massachusetts
Study officials:
affiliation: The Forsyth Institute
name: J Max Goodson, DDS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Forsyth Institute
name: Anne D Haffajee, BDS
role: PRINCIPAL_INVESTIGATOR
References: