The Forsyth Institute
Boston, Massachusetts, 02115, United States
NCT Number: NCT01098448
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.
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Notify Me20 year and older
All sexes
Interventional
Phase 3
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
scaling and root planing as a single therapy
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
periodontal surgery in residual pockets of >4mm
1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
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)
Time frame: 24 months
Time frame: 24 months
The Forsyth Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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