Clinical Trials Directory

Trials / Completed

CompletedNCT02466646

Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients

Evaluation of Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels and Periodontal Pathogens After Full-Mouth Disinfection Initial Periodontal Treatment in Generalized Aggressive Periodontitis Patients

Status
Completed
Phase
Phase 4
Study type
Interventional
Enrollment
42 (actual)
Sponsor
Marmara University · Academic / Other
Sex
All
Age
18 Years – 35 Years
Healthy volunteers
Accepted

Summary

The purpose of this study is to determine whether full-mouth disinfection is effective in the initial periodontal treatment of generalized aggressive periodontitis on clinical parameters, gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17) and periodontal pathogen levels compared with conventional initial periodontal treatment and full-mouth initial periodontal treatment. The investigators' hypothesis is to test whether full-mouth disinfection in the initial periodontal treatment of generalized aggressive periodontitis enhance the clinical, biochemical and microbiological parameters in comparison to conventional initial periodontal treatment and full-mouth initial periodontal treatment.

Detailed description

The present study aimed to compare the efficacy of conventional initial periodontal treatment (C-IPT), full-mouth disinfection IPT (FMD-IPT) and full-mouth IPT (FM-IPT) and the levels of gingival crevicular fluid interleukin-1β (IL-1β) and interleukin-17 (IL-17), Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Parvimonas micra and Campylobacter rectus in patients with generalized aggressive periodontitis (GAgP) over 6-months period. Forty-two GAgP patients were randomly assigned into 3 groups. IPT was performed in a quadrant-wise manner at 1-week intervals in C-IPT, in 2 sessions within 24 hours in FM-IPT, and in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours in FMD-IPT. FMD-IPT group also used daily 0,2% chlorhexidine for 3 weeks. At baseline, 3 and 6 months clinical parameters consisting of plaque index, gingival index, probing depth, bleeding on probing and clinical attachment level were recorded, gingival crevicular fluid and microbiological samples were collected. Gingival crevicular fluid levels of IL-1β and IL-17 were analyzed using ELISA. The quantitative real-time polymerase chain reaction method was used for the quantitative detection of periodontal pathogens.

Conditions

Interventions

TypeNameDescription
DRUGKlorhex® Gel, rinse and sprayInitial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).
PROCEDUREConventional IPTInitial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
PROCEDUREFull-mouth IPTInitial periodontal treatment was performed in 2 sessions within 24 hours.

Timeline

Start date
2012-12-01
Primary completion
2014-09-01
Completion
2014-09-01
First posted
2015-06-09
Last updated
2020-06-09
Results posted
2020-06-09

Source: ClinicalTrials.gov record NCT02466646. Inclusion in this directory is not an endorsement.