Clinical trial NCT02466646: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aggressive Periodontitis
Keywords: Periodontal Debridement
Gingival Crevicular Fluid
Aggressive Periodontitis
Interleukin-1beta
Interleukin-17
Bacteria
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2015-06-09
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Probing Depth
timeFrame: 6 months after initial periodontal treatment
Secondary outcomes:
measure: Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Level of A. Actinomycetemcomitans
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Level of Porphyromonas Gingivalis
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Level of Fusobacterium Nucleatum
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Level of Parvimonas Micra
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Bleeding on Probing
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Plaque Index
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Gingival Index
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Clinical Attachment Level
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Level of Prevotella Intermedia
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
measure: Level of Campylobacter Rectus
timeFrame: Baseline, 3 and 6 months after initial periodontal treatment
Other outcomes:
Locations:
Study officials:
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Basak Dogan, Prof. Dr.
role: STUDY_DIRECTOR
affiliation: Marmara University, Faculty of Dentistry, Department of Periodontology
name: Dilek Mamaklioglu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.