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

M

Marmara University

Status and phase

Completed
Phase 4

Conditions

Aggressive Periodontitis

Treatments

Procedure: Conventional IPT
Procedure: Full-mouth IPT
Drug: Klorhex® Gel, rinse and spray

Study type

Interventional

Funder types

Other

Identifiers

NCT02466646
SAG-C-DRP-280214-0043

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 35 years old

Volunteers

Accepts 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

42 participants in 3 patient groups

Full-mouth Disinfection IPT
Active Comparator group
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).
Treatment:
Drug: Klorhex® Gel, rinse and spray
Conventional IPT
Experimental group
Description:
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Treatment:
Procedure: Conventional IPT
Full-mouth IPT
Experimental group
Description:
Initial periodontal treatment was performed in 2 sessions within 24 hours.
Treatment:
Procedure: Full-mouth IPT

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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