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

May 27, 2020 updated by: Marmara University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

42

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Drug: 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).
Other Names:
  • FMD
Experimental: Conventional IPT
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Procedure: Conventional IPT
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Other Names:
  • Q-SRP
Experimental: Full-mouth IPT
Initial periodontal treatment was performed in 2 sessions within 24 hours.
Procedure: Full-mouth IPT
Initial periodontal treatment was performed in 2 sessions within 24 hours.
Other Names:
  • FM-SRP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Probing Depth
Time Frame: 6 months after initial periodontal treatment
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)
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Level of A. Actinomycetemcomitans
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Level of Porphyromonas Gingivalis
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Level of Fusobacterium Nucleatum
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Level of Parvimonas Micra
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Bleeding on Probing
Time Frame: 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.
Baseline, 3 and 6 months after initial periodontal treatment
Plaque Index
Time Frame: 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
Baseline, 3 and 6 months after initial periodontal treatment
Gingival Index
Time Frame: 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
Baseline, 3 and 6 months after initial periodontal treatment
Clinical Attachment Level
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Level of Prevotella Intermedia
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment
Level of Campylobacter Rectus
Time Frame: Baseline, 3 and 6 months after initial periodontal treatment
Baseline, 3 and 6 months after initial periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marmara University

Investigators

  • Study Director: Basak Dogan, Prof. Dr., Marmara University, Faculty of Dentistry, Department of Periodontology
  • Principal Investigator: Dilek Mamaklioglu, Dr., Marmara University, Faculty of Dentistry, Department of Periodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 27, 2015

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

June 9, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAG-C-DRP-280214-0043

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Aggressive Periodontitis

Clinical Trials on Klorhex® Gel, rinse and spray

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe