- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07345520
VCMX, PRF and SCTG Treatment in the Gingival Recessions
January 7, 2026 updated by: Seyma Bozkurt Doğan, Bulent Ecevit University
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
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ankara, Turkey (Türkiye)
- Ankara Yıldırım Beyazit University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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;
- 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.
Exclusion criteria included:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Volume-Stable Collagen Matrix
|
|
Active Comparator: 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.
|
Volume-Stable Collagen Matrix
|
|
Active Comparator: 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.
|
Volume-Stable Collagen Matrix
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Mean Root Coverage
Time Frame: 12 months
|
Percentage of root coverage will be calculated as: Percentage of root coverage: [(preoperative recession depth - postoperative recession depth) ÷ preoperative recession depth] × 100
|
12 months
|
|
Recession depth
Time Frame: 12 month
|
RD will be measured from the cemento-enamel junction (CEJ) to the gingival margin and reported in millimeters (mm).
|
12 month
|
|
Probing depth
Time Frame: 12 months
|
Probing depth will be measured from the gingival margin to the base of the sulcus and reported in millimeters (mm).
|
12 months
|
|
Clinical attachment level
Time Frame: 12 months
|
Clinical attachment level will be measured from the cemento-enamel junction to the sulcus base and reported in millimeters (mm).
|
12 months
|
|
Keratinized gingiva width
Time Frame: 12 months
|
KGW will be measured from the mucogingival junction to the gingival margin and reported in millimeters (mm).
|
12 months
|
|
Gingival Thickness
Time Frame: 12 months
|
Gingival thickness (GT) will beevaluated at the mid-facial aspect, 2 mm apical to the gingival margin in the attached gingiva or alveolar mucosa, using a #15 endodontic spreader (Bahadır Diş, Istanbul, Turkey) with a rubber stopper under local anesthesia and reported in milimeters.
|
12 months
|
|
Postoperative Pain assessed using a Visual Analog Scale (VAS)
Time Frame: From the day of surgery through postoperative day 10 (11 days)
|
Postoperative pain will be assessed using a visual analog scale (VAS).
Patients were asked to record the highest perceived pain each day from the day of surgery through the 10th postoperative day (total of 11 days).
|
From the day of surgery through postoperative day 10 (11 days)
|
|
Dentin Hypersensitivity Score assessed using Air Stimulus (HSS)
Time Frame: Baseline, 6 months, and 12 months
|
Dentin hypersensitivity will be assessed using a 1-second air stimulus applied to the buccal surface of the treated tooth.
Patients rated the perceived hypersensitivity on a numerical rating scale ranging from 0 (no hypersensitivity) to 10 (unbearable hypersensitivity).
|
Baseline, 6 months, and 12 months
|
|
Pink Esthetic Score (PES) self-assessment
Time Frame: Baseline, 6 months, and 12 months
|
Esthetic outcomes will be evaluated using the Pink Esthetic Score (PES).
Patients self-assessed gingival contour, gingival color, and overall esthetic appearance using a numerical rating scale ranging from 0 (unpleasant) to 10 (excellent).
|
Baseline, 6 months, and 12 months
|
|
Postoperative Analgesic Consumption
Time Frame: From the day of surgery through postoperative day 10 (11 days)
|
Postoperative analgesic consumption will be assessed by recording the total number of analgesic tablets taken by patients from the day of surgery through the 10th postoperative day.
|
From the day of surgery through postoperative day 10 (11 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2022
Primary Completion (Actual)
October 1, 2024
Study Completion (Actual)
October 1, 2024
Study Registration Dates
First Submitted
November 23, 2025
First Submitted That Met QC Criteria
January 7, 2026
First Posted (Actual)
January 15, 2026
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 7, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21.12.2022/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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