Comparison of Volume Stable Collagen Matrix, Platelet-Rich Fibrin and Connective Tissue Graft in the Treatment of Multiple Gingival Recessions: A Randomized, Parallel Group, Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Percentage of Complete Root Coverage
Study Overview
Brief Summary
Comparison of Volume-Stable Collagen Matrix, Platelet-Rich Fibrin, and Subepithelial Connective Tissue Graft in the Treatment of Multiple Adjacent Gingival Recessions: A Parallel-Group, Randomized, Controlled Clinical Trial
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •were as follows:
- •≥2 mm buccal recessions affecting ≥2 adjacent maxillary teeth;
- •systemically and periodontally healthy;
- •non-smokers;
- •Miller Class I-II (no interproximal attachment or CEJ loss);
- •probing depth (PD) <3 mm;
- •identifiable CEJ;
- •full-mouth plaque index (PI) <20%(O'Leary et al., 1972) and gingival index (GI) score of 0(Löe, 1967) and
- •vital teeth to be treated.
Exclusion Criteria
- •caries/restorations/abrasions in the treated area, furcation involvement;
- •contraindications to surgery;
- •pregnancy or lactation;
- •medications compromising healing;
- •surgery in the same region within 2 years;
- •bleeding disorders;
- •requirement for antibiotic prophylaxis; and
- •collagen allergy.
Arms & Interventions
Volume Stable Collagen Matrix+Coronally Advanced Flap
The pre-prepared Volume Stable Collagen Matrix will be moistened with saline solution (SF) and placed beneath a coronally positioned flap at the recipient site during periodontal surgery.
Intervention: Volume-Stable Collagen Matrix (Biological)
Platelet-Rich Fibrin+Coronally Advanced Flap
Autologous platelet-rich fibrin (PRF) will be prepared from the patient's venous blood according to a standardized protocol and placed beneath a coronally advanced flap at the recipient site during periodontal surgery to enhance soft tissue healing and regeneration.
Intervention: Volume-Stable Collagen Matrix (Biological)
Subepithelial Connective Tissue Graft+Coronally Advanced Flap
A subepithelial connective tissue graft harvested from the patient's palate and placed beneath a coronally positioned flap at the recipient site during periodontal surgery.
Intervention: Volume-Stable Collagen Matrix (Biological)
Outcomes
Primary Outcomes
Percentage of Complete Root Coverage
Time Frame: 12 Months
Percentage of CRC will be calculated as: (number of teeth achieving complete root coverage) ÷ (total treated teeth)\] × 100
Secondary Outcomes
- Percentage of Mean Root Coverage(12 months)
- Recession depth(12 month)
- Probing depth(12 months)
- Clinical attachment level(12 months)
- Keratinized gingiva width(12 months)
- Gingival Thickness(12 months)
- Postoperative Pain assessed using a Visual Analog Scale (VAS)(From the day of surgery through postoperative day 10 (11 days))
- Dentin Hypersensitivity Score assessed using Air Stimulus (HSS)(Baseline, 6 months, and 12 months)
- Pink Esthetic Score (PES) self-assessment(Baseline, 6 months, and 12 months)
- Postoperative Analgesic Consumption(From the day of surgery through postoperative day 10 (11 days))
Investigators
Seyma Bozkurt Doğan
Prof. Dr.
Ankara Yildirim Beyazıt University