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NCT Number: NCT02466646

Evaluation of Efficacy of Full-mouth Disinfection 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.

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Key information

Conditions

Aggressive Periodontitis Mouth Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Klorhex® Gel, rinse and spray

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).

Other names: FMD

Conventional IPT

Procedure

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

Other names: Q-SRP

Full-mouth IPT

Procedure

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

Other names: FM-SRP

Primary outcomes

  1. Probing Depth

    Time frame: 6 months after initial periodontal treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 9, 2015
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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