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

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ClinicalTrials.gov Identifier: NCT02466646
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : June 9, 2020
Last Update Posted : June 9, 2020
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Aggressive Periodontitis Drug: Klorhex® Gel, rinse and spray Procedure: Conventional IPT Procedure: Full-mouth IPT Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: FM-SRP




Primary Outcome Measures :
  1. Probing Depth [ Time Frame: 6 months after initial periodontal treatment ]

Secondary Outcome Measures :
  1. Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg) [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  2. Level of A. Actinomycetemcomitans [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  3. Level of Porphyromonas Gingivalis [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  4. Level of Fusobacterium Nucleatum [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  5. Level of Parvimonas Micra [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  6. 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.

  7. 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

  8. 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

  9. Clinical Attachment Level [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  10. Level of Prevotella Intermedia [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]
  11. Level of Campylobacter Rectus [ Time Frame: Baseline, 3 and 6 months after initial periodontal treatment ]


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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466646


Sponsors and Collaborators
Marmara University
Investigators
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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:
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Responsible Party: Marmara University
ClinicalTrials.gov Identifier: NCT02466646    
Other Study ID Numbers: SAG-C-DRP-280214-0043
First Posted: June 9, 2015    Key Record Dates
Results First Posted: June 9, 2020
Last Update Posted: June 9, 2020
Last Verified: May 2020
Keywords provided by Marmara University:
Periodontal Debridement
Gingival Crevicular Fluid
Aggressive Periodontitis
Interleukin-1beta
Interleukin-17
Bacteria
Additional relevant MeSH terms:
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Periodontitis
Aggressive Periodontitis
Aggression
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms