Phase 4
N=42
Evaluation of Efficacy of Full-mouth Disinfection in Generalized Aggressive Periodontitis Patients
Aggressive Periodontitis
Bottom Line
View on ClinicalTrials.gov: NCT02466646 ↗Enrolled (actual)
42
Serious AEs
—
Results posted
Jun 2020
Primary outcome: Primary: Probing Depth — 4.55; 4.80; 4.90; 2.71 mm — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Klorhex® Gel, rinse and spray (Drug); Conventional IPT (Procedure); Full-mouth IPT (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Marmara University
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Probing Depth |
4.55; 4.80; 4.90; 2.71; 3.40; 3.04 | <0.01 sig |
| SECONDARY Gingival Crevicular Fluid Interleukin-1β and Interleukin-17 Levels (pg) |
2.53; 2.27; 2.15; 2.07; 2.11; 2.06 | >0.05 |
| SECONDARY Level of A. Actinomycetemcomitans |
3.65; 3.84; 3.63; 3.27; 3.73; 3.47 | 0.229 |
| SECONDARY Level of Porphyromonas Gingivalis |
4.64; 5.50; 5.47; 2.90; 3.60; 3.74 | 0.280 |
| SECONDARY Level of Fusobacterium Nucleatum |
4.67; 4.78; 4.66; 3.84; 3.99; 4.42 | 0.712 |
| SECONDARY Level of Parvimonas Micra |
4.96; 4.86; 4.70; 4.22; 4.34; 4.51 | 0.674 |
| SECONDARY Bleeding on Probing |
78.30; 89.28; 85.77; 38.87; 54.43; 48.90 | 0.006 sig |
| SECONDARY Plaque Index |
1.51; 1.76; 1.62; 0.67; 0.69; 0.84 | 0.373 |
| SECONDARY Gingival Index |
1.61; 1.80; 1.74; 1.17; 1.15; 1.24 | 0.528 |
| SECONDARY Clinical Attachment Level |
5.20; 5.67; 5.79; 4.54; 4.94; 5.10 | 0.208 |
| SECONDARY Level of Prevotella Intermedia |
4.24; 5.51; 4.84; 2.73; 3.70; 3.81 | 0.051 |
| SECONDARY Level of Campylobacter Rectus |
5.95; 6.19; 5.99; 4.63; 5.01; 5.25 | 0.647 |
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.
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
Data sourced from ClinicalTrials.gov (NCT02466646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.