A Comparison of Single-Stage Full-Mouth Disinfection With Quadrant-Based Scaling and Root Planing in Patients With Uncontrolled Type 2 Diabetes and Severe Periodontitis: An Assessment of Its Impact on Quality of Life
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pamukkale University
- Enrollment
- 82
- Locations
- 1
Study Overview
Brief Summary
This study evaluated the effects of a single-stage full mouth disinfection (FMD) protocol versus a quadrant-based tooth surface cleaning and root planing (Q-SRP) protocol on changes in clinical periodontal parameters over a 3-month period, as well as on the social, psychological and functional well-being of patients with poorly controlled type 2 diabetes and severe periodontitis.
Detailed Description
In this study, Q-SRP was administered to one group of patients with uncontrolled diabetes and severe periodontitis, whilst the TAD protocol was implemented in the other group. All clinical procedures were carried out in accordance with standard protocols. Post-treatment assessments were carried out at the 1-month and 3-month follow-up periods; all clinical periodontal measurements recorded at baseline, along with the OHIP-14 and OIDP questionnaires, were repeated in the same manner. This enabled a comparative analysis of the efficacy of the treatment methods applied and the clinical changes over time.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Individuals with poorly controlled diabetes and HbA1c levels between 7% and 9%
- •At least 15 natural teeth and, from a periodontal perspective: probing pocket depth (PPD) ≥ 6 mm, clinical attachment loss (CAL) ≥ 5 mm, radiographic bone loss extending to the middle or apical third of the root, and periodontitis-related tooth loss of ≤ 4 in different quadrants
Exclusion Criteria
- •Individuals who were pregnant or breastfeeding
- •Patients with a history of acute or chronic infection within the past 6 months
- •Patients who had undergone periodontal treatment within the past 6 months
- •Patients receiving systemic antibiotic therapy during the same period
- •Patients using non-steroidal anti-inflammatory drugs, phenytoin, calcium channel blockers or cyclosporine
- •Patients undergoing hormone therapy
- •Individuals who had used antibiotics or anti-inflammatory drugs regularly during the 3-month period following the start of the study
- •İndividuals with medical or psychological conditions that could affect the accurate understanding and completion of the questionnaires
Investigators
Emine Ece Barlay
Research Assistant
Pamukkale University