NCT07345520

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 15, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

November 23, 2025

Last Update Submit

January 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Percentage of Complete Root Coverage

    Percentage of CRC will be calculated as: (number of teeth achieving complete root coverage) ÷ (total treated teeth)\] × 100

    12 Months

Secondary Outcomes (10)

  • 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

  • +5 more secondary outcomes

Study Arms (3)

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.

Biological: Volume-Stable Collagen Matrix

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.

Biological: Volume-Stable Collagen Matrix

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.

Biological: Volume-Stable Collagen Matrix

Interventions

Volume-Stable Collagen Matrix

Platelet-Rich Fibrin+Coronally Advanced FlapSubepithelial Connective Tissue Graft+Coronally Advanced FlapVolume Stable Collagen Matrix+Coronally Advanced Flap

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥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;
  • GT ≥1 mm;
  • KGW ≥2 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.

You may not qualify if:

  • smokers;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Yıldırım Beyazit University

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A Parallel-Group, Randomized, Controlled Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 23, 2025

First Posted

January 15, 2026

Study Start

December 1, 2022

Primary Completion

October 1, 2024

Study Completion

October 1, 2024

Last Updated

January 15, 2026

Record last verified: 2026-01

Locations