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Clinical Trials/NCT07345520
NCT07345520CompletedPhase 3

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

Bulent Ecevit University1 site in 1 country60 target enrollmentStarted: December 1, 2022Last updated:
Interventions

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

Experimental

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

Active Comparator

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

Active Comparator

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

Sponsor
Bulent Ecevit University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Seyma Bozkurt Doğan

Prof. Dr.

Ankara Yildirim Beyazıt University

Study Sites (1)

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