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VCMX, PRF and SCTG Treatment in the Gingival Recessions

B

Bulent Ecevit University

Status and phase

Completed
Phase 3

Conditions

Gingival Recession, Localized

Treatments

Biological: Volume-Stable Collagen Matrix

Study type

Interventional

Funder types

Other

Identifiers

NCT07345520
21.12.2022/12

Details and patient eligibility

About

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

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria were as follows:

  1. ≥2 mm buccal recessions affecting ≥2 adjacent maxillary teeth;
  2. systemically and periodontally healthy;
  3. non-smokers;
  4. Miller Class I-II (no interproximal attachment or CEJ loss);
  5. probing depth (PD) <3 mm;
  6. GT ≥1 mm;
  7. KGW ≥2 mm;
  8. identifiable CEJ;
  9. full-mouth plaque index (PI) <20%(O'Leary et al., 1972) and gingival index (GI) score of 0(Löe, 1967) and
  10. vital teeth to be treated.

Exclusion criteria included:

  1. smokers;
  2. caries/restorations/abrasions in the treated area, furcation involvement;
  3. contraindications to surgery;
  4. pregnancy or lactation;
  5. medications compromising healing;
  6. surgery in the same region within 2 years;
  7. bleeding disorders;
  8. requirement for antibiotic prophylaxis; and
  9. collagen allergy.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 3 patient groups

Volume Stable Collagen Matrix+Coronally Advanced Flap
Experimental group
Description:
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.
Treatment:
Biological: Volume-Stable Collagen Matrix
Platelet-Rich Fibrin+Coronally Advanced Flap
Active Comparator group
Description:
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.
Treatment:
Biological: Volume-Stable Collagen Matrix
Subepithelial Connective Tissue Graft+Coronally Advanced Flap
Active Comparator group
Description:
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.
Treatment:
Biological: Volume-Stable Collagen Matrix

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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