VCMX, PRF and SCTG Treatment in the Gingival Recessions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-10-01

Brief Summary

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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

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Detailed Description

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Conditions

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Gingival Recession, Localized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A Parallel-Group, Randomized, Controlled Clinical Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Volume-Stable Collagen Matrix

Intervention Type BIOLOGICAL

Volume-Stable Collagen Matrix

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.

Group Type ACTIVE_COMPARATOR

Volume-Stable Collagen Matrix

Intervention Type BIOLOGICAL

Volume-Stable Collagen Matrix

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.

Group Type ACTIVE_COMPARATOR

Volume-Stable Collagen Matrix

Intervention Type BIOLOGICAL

Volume-Stable Collagen Matrix

Interventions

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Volume-Stable Collagen Matrix

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes