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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-09-30

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.

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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.

Conditions

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Aggressive Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Full-mouth Disinfection IPT

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).

Group Type ACTIVE_COMPARATOR

Klorhex® Gel, rinse and spray

Intervention Type DRUG

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

Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

Group Type EXPERIMENTAL

Conventional IPT

Intervention Type PROCEDURE

Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

Full-mouth IPT

Initial periodontal treatment was performed in 2 sessions within 24 hours.

Group Type EXPERIMENTAL

Full-mouth IPT

Intervention Type PROCEDURE

Initial periodontal treatment was performed in 2 sessions within 24 hours.

Interventions

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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).

Intervention Type DRUG

Conventional IPT

Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.

Intervention Type PROCEDURE

Full-mouth IPT

Initial periodontal treatment was performed in 2 sessions within 24 hours.

Intervention Type PROCEDURE

Other Intervention Names

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FMD Q-SRP FM-SRP

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes