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

NCT02466646 | Completed Phase 4 Results

• 1 other identifier: SAG-C-DRP-280214-0043
• Study Type: interventional
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Aggressive Periodontitis

Keywords

Periodontal Debridement; Gingival Crevicular Fluid; Aggressive Periodontitis; Interleukin-1beta; Interleukin-17; Bacteria

Outcome Measures

Primary Outcomes (1)

• Probing Depth

  6 months after initial periodontal treatment

Secondary Outcomes (11)

• Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)

  Baseline, 3 and 6 months after initial periodontal treatment

• Level of A. Actinomycetemcomitans

  Baseline, 3 and 6 months after initial periodontal treatment

• Level of Porphyromonas Gingivalis

  Baseline, 3 and 6 months after initial periodontal treatment

• Level of Fusobacterium Nucleatum

  Baseline, 3 and 6 months after initial periodontal treatment

• Level of Parvimonas Micra

  Baseline, 3 and 6 months after initial periodontal treatment

Study Arms (3)

Full-mouth Disinfection IPT

ACTIVE COMPARATOR

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

Conventional IPT

EXPERIMENTAL

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

Procedure: Conventional IPT

Full-mouth IPT

EXPERIMENTAL

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

Procedure: Full-mouth IPT

Interventions

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).

Also known as: FMD

Full-mouth Disinfection IPT

Conventional IPT PROCEDURE

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

Also known as: Q-SRP

Conventional IPT

Full-mouth IPT PROCEDURE

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

Also known as: FM-SRP

Full-mouth IPT

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Related 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.

  PMID: 22220822 BACKGROUND

• 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.

  PMID: 10397519 BACKGROUND

• 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.

  PMID: 22126282 BACKGROUND

MeSH Terms

Conditions

Aggressive Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Prof. Dr. Basak Dogan
• Organization: Marmara University Faculty of Dentistry, Department of Periodontology

basak.sdogan@gmail.com

00905332621170

Study Officials

• Basak Dogan, Prof. Dr.

  Marmara University, Faculty of Dentistry, Department of Periodontology

  STUDY DIRECTOR

• Dilek Mamaklioglu, Dr.

  Marmara University, Faculty of Dentistry, Department of Periodontology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: June 9, 2015
• Study Start: December 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 9, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05