Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
Primary Purpose
Aggressive Periodontitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Klorhex® Gel, rinse and spray
Conventional IPT
Full-mouth IPT
Sponsored by
About this trial
This is an interventional treatment trial for Aggressive Periodontitis focused on measuring Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Full-mouth Disinfection IPT
Conventional IPT
Full-mouth IPT
Arm 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).
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Initial periodontal treatment was performed in 2 sessions within 24 hours.
Outcomes
Primary Outcome Measures
Probing Depth
Secondary Outcome Measures
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
Level of A. Actinomycetemcomitans
Level of Porphyromonas Gingivalis
Level of Fusobacterium Nucleatum
Level of Parvimonas Micra
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.
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
Gingival Index
Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
Clinical Attachment Level
Level of Prevotella Intermedia
Level of Campylobacter Rectus
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02466646
Brief Title
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
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marmara University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aggressive Periodontitis
Keywords
Periodontal Debridement, Gingival Crevicular Fluid, Aggressive Periodontitis, Interleukin-1beta, Interleukin-17, Bacteria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full-mouth Disinfection IPT
Arm Type
Active Comparator
Arm 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).
Arm Title
Conventional IPT
Arm Type
Experimental
Arm Description
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Arm Title
Full-mouth IPT
Arm Type
Experimental
Arm Description
Initial periodontal treatment was performed in 2 sessions within 24 hours.
Intervention Type
Drug
Intervention Name(s)
Klorhex® Gel, rinse and spray
Other Intervention Name(s)
FMD
Intervention 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).
Intervention Type
Procedure
Intervention Name(s)
Conventional IPT
Other Intervention Name(s)
Q-SRP
Intervention Description
Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
Intervention Type
Procedure
Intervention Name(s)
Full-mouth IPT
Other Intervention Name(s)
FM-SRP
Intervention Description
Initial periodontal treatment was performed in 2 sessions within 24 hours.
Primary Outcome Measure Information:
Title
Probing Depth
Time Frame
6 months after initial periodontal treatment
Secondary Outcome Measure Information:
Title
Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg)
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Level of A. Actinomycetemcomitans
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Level of Porphyromonas Gingivalis
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Level of Fusobacterium Nucleatum
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Level of Parvimonas Micra
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Bleeding on Probing
Description
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.
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Plaque Index
Description
Possible scores for Plaque Index range from 0 (no plaque) to 3 (visible plaque all around the tooth). Higher scores mean a worse outcome
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Gingival Index
Description
Possible score for Gingival Index range from 0 (healthy gingiva) to 3 (severe gingivitis with bleeding). Higher scores mean worse outcome
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Clinical Attachment Level
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Level of Prevotella Intermedia
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
Title
Level of Campylobacter Rectus
Time Frame
Baseline, 3 and 6 months after initial periodontal treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Dogan, Prof. Dr.
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dilek Mamaklioglu, Dr.
Organizational Affiliation
Marmara University, Faculty of Dentistry, Department of Periodontology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22220822
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.
Results Reference
background
PubMed Identifier
10397519
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.
Results Reference
background
PubMed Identifier
22126282
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.
Results Reference
background
Learn more about this trial
Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
We'll reach out to this number within 24 hrs