search
Back to results

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

Primary Purpose

Aggressive Periodontitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Klorhex® Gel, rinse and spray
Conventional IPT
Full-mouth IPT
Sponsored by
Marmara University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aggressive Periodontitis focused on measuring Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Full-mouth Disinfection IPT

    Conventional IPT

    Full-mouth IPT

    Arm Description

    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).

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

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

    Outcomes

    Primary Outcome Measures

    Probing Depth

    Secondary Outcome Measures

    Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
    Level of A. Actinomycetemcomitans
    Level of Porphyromonas Gingivalis
    Level of Fusobacterium Nucleatum
    Level of Parvimonas Micra
    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.
    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
    Gingival Index
    Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
    Clinical Attachment Level
    Level of Prevotella Intermedia
    Level of Campylobacter Rectus

    Full Information

    First Posted
    May 27, 2015
    Last Updated
    May 27, 2020
    Sponsor
    Marmara University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02466646
    Brief Title
    Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2012 (undefined)
    Primary Completion Date
    September 2014 (Actual)
    Study Completion Date
    September 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Marmara University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aggressive Periodontitis
    Keywords
    Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Full-mouth Disinfection IPT
    Arm Type
    Active Comparator
    Arm Description
    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).
    Arm Title
    Conventional IPT
    Arm Type
    Experimental
    Arm Description
    Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
    Arm Title
    Full-mouth IPT
    Arm Type
    Experimental
    Arm Description
    Initial periodontal treatment was performed in 2 sessions within 24 hours.
    Intervention Type
    Drug
    Intervention Name(s)
    Klorhex® Gel, rinse and spray
    Other Intervention Name(s)
    FMD
    Intervention Description
    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
    Procedure
    Intervention Name(s)
    Conventional IPT
    Other Intervention Name(s)
    Q-SRP
    Intervention Description
    Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
    Intervention Type
    Procedure
    Intervention Name(s)
    Full-mouth IPT
    Other Intervention Name(s)
    FM-SRP
    Intervention Description
    Initial periodontal treatment was performed in 2 sessions within 24 hours.
    Primary Outcome Measure Information:
    Title
    Probing Depth
    Time Frame
    6 months after initial periodontal treatment
    Secondary Outcome Measure Information:
    Title
    Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Level of A. Actinomycetemcomitans
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Level of Porphyromonas Gingivalis
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Level of Fusobacterium Nucleatum
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Level of Parvimonas Micra
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Bleeding on Probing
    Description
    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.
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Plaque Index
    Description
    Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Gingival Index
    Description
    Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Clinical Attachment Level
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Level of Prevotella Intermedia
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment
    Title
    Level of Campylobacter Rectus
    Time Frame
    Baseline, 3 and 6 months after initial periodontal treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Basak Dogan, Prof. Dr.
    Organizational Affiliation
    Marmara University, Faculty of Dentistry, Department of Periodontology
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Dilek Mamaklioglu, Dr.
    Organizational Affiliation
    Marmara University, Faculty of Dentistry, Department of Periodontology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    22220822
    Citation
    Aimetti M, Romano F, Guzzi N, Carnevale G. Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. J Clin Periodontol. 2012 Mar;39(3):284-94. doi: 10.1111/j.1600-051X.2011.01795.x. Epub 2012 Jan 4.
    Results Reference
    background
    PubMed Identifier
    10397519
    Citation
    Mongardini C, van Steenberghe D, Dekeyser C, Quirynen M. One stage full- versus partial-mouth disinfection in the treatment of chronic adult or generalized early-onset periodontitis. I. Long-term clinical observations. J Periodontol. 1999 Jun;70(6):632-45. doi: 10.1902/jop.1999.70.6.632.
    Results Reference
    background
    PubMed Identifier
    22126282
    Citation
    de Lima Oliveira AP, de Faveri M, Gursky LC, Mestnik MJ, Feres M, Haffajee AD, Socransky SS, Teles RP. Effects of periodontal therapy on GCF cytokines in generalized aggressive periodontitis subjects. J Clin Periodontol. 2012 Mar;39(3):295-302. doi: 10.1111/j.1600-051X.2011.01817.x. Epub 2011 Nov 30.
    Results Reference
    background

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs