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

Phase 4

Completed

• Conditions: Aggressive Periodontitis
• Interventions: Drug: Klorhex® Gel, rinse and spray; Procedure: Conventional IPT; Procedure: Full-mouth IPT

• Registration Number: NCT02466646
• Lead Sponsor: Marmara University

Brief 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.

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Study First Submitted: 2015-05-27
• Study First Submitted QC: 2015-06-04
• Study First Posted: 2015-06-09
• Results First Submitted: 2020-04-13
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-27
• Last Update Submitted: 2020-05-27
• Results First Posted: 2020-06-09
• Last Update Posted: 2020-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• No systemic diseases that could influence the outcome of the therapy
• No smoking
• No medications affecting periodontal tissues
• No pregnancy or lactation
• Presence of at least 15 teeth

Exclusion Criteria

• Received antibiotic treatment in the previous 3 months
• Smokers
• Pregnancy and lactation
• Received periodontal treatment in the previous 6 months
• Presence of less than 15 teeth
• Presence of systemic diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Full-mouth Disinfection IPT	Klorhex® Gel, rinse and spray	Initial 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).
Conventional IPT	Conventional IPT	Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Full-mouth IPT	Full-mouth IPT	Initial periodontal treatment was performed in 2 sessions within 24 hours.

Primary Outcome Measures

Name	Time	Method
Probing Depth	6 months after initial periodontal treatment

Secondary Outcome Measures

Name	Time	Method
Bleeding on Probing	Baseline, 3 and 6 months after initial periodontal treatment	Possible score for BOP range from %0 (no sites with bleeding on probing) to %100 (all sites with bleeding on probing). Higher scores mean worse outcome.
Gingival Index	Baseline, 3 and 6 months after initial periodontal treatment	Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
Clinical Attachment Level	Baseline, 3 and 6 months after initial periodontal treatment
Level of Porphyromonas Gingivalis	Baseline, 3 and 6 months after initial periodontal treatment
Level of A. Actinomycetemcomitans	Baseline, 3 and 6 months after initial periodontal treatment
Level of Prevotella Intermedia	Baseline, 3 and 6 months after initial periodontal treatment
Level of Campylobacter Rectus	Baseline, 3 and 6 months after initial periodontal treatment
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)	Baseline, 3 and 6 months after initial periodontal treatment
Level of Fusobacterium Nucleatum	Baseline, 3 and 6 months after initial periodontal treatment
Level of Parvimonas Micra	Baseline, 3 and 6 months after initial periodontal treatment
Plaque Index	Baseline, 3 and 6 months after initial periodontal treatment	Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome