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

Aggressive Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02466646
• Other study ID #: SAG-C-DRP-280214-0043
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: May 2020
• Source: Marmara University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggression
• Aggressive Periodontitis
• Periodontitis

Intervention

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).

Procedure:
• Conventional IPT
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
• Full-mouth IPT
Initial periodontal treatment was performed in 2 sessions within 24 hours.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Marmara University

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing Depth		6 months after initial periodontal treatment
Secondary	Gingival Crevicular Fluid Interleukin-1ß and Interleukin-17 Levels (pg)		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Level of A. Actinomycetemcomitans		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Level of Porphyromonas Gingivalis		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Level of Fusobacterium Nucleatum		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Level of Parvimonas Micra		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	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.	Baseline, 3 and 6 months after initial periodontal treatment
Secondary	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	Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Gingival Index	Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome	Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Clinical Attachment Level		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Level of Prevotella Intermedia		Baseline, 3 and 6 months after initial periodontal treatment
Secondary	Level of Campylobacter Rectus		Baseline, 3 and 6 months after initial periodontal treatment