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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Aggressive Periodontitis

Intervention / Treatment
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* Drug: Klorhex® Gel, rinse and spray
* Procedure: Conventional IPT
* Procedure: Full-mouth IPT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Full-mouth Disinfection IPT<br>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). | Drug: Klorhex® Gel, rinse and spray<br>* 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).<br>* Other names: FMD;|
| Experimental: Conventional IPT<br>Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals. | Procedure: Conventional IPT<br>* Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.<br>* Other names: Q-SRP;|
| Experimental: Full-mouth IPT<br>Initial periodontal treatment was performed in 2 sessions within 24 hours. | Procedure: Full-mouth IPT<br>* Initial periodontal treatment was performed in 2 sessions within 24 hours.<br>* Other names: FM-SRP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Probing Depth |  | 6 months after initial periodontal treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg) |  | Baseline, 3 and 6 months after initial periodontal treatment | 
| Level of A. Actinomycetemcomitans |  | Baseline, 3 and 6 months after initial periodontal treatment | 
| Level of Porphyromonas Gingivalis |  | 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 | 
| Bleeding on Probing | 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. | Baseline, 3 and 6 months after initial periodontal treatment | 
| Plaque Index | Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome | Baseline, 3 and 6 months after initial periodontal treatment | 
| Gingival Index | Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome | Baseline, 3 and 6 months after initial periodontal treatment | 
| Clinical Attachment Level |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria