Gingival Recession, LocalizedPhase 3NCT07345520
VCMX, PRF and SCTG Treatment in the Gingival Recessions
A Phase 3 study testing Volume-Stable Collagen Matrix in people with Gingival Recession, Localized, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Recession, Localized
- What is being tested?
- Volume-Stable Collagen Matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Oct 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥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;
Show all 10Show fewer
- 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.
Who cannot join
- 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;
Show all 9Show fewer
- bleeding disorders;
- requirement for antibiotic prophylaxis; and
- collagen allergy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Gingival Recession, Localized
- Being tested
- Volume-Stable Collagen Matrix
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volume-Stable Collagen MatrixBiological
Volume-Stable Collagen Matrix
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Biological: Volume-Stable Collagen Matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Complete Root Coverage
Percentage of CRC will be calculated as: (number of teeth achieving complete root coverage) ÷ (total treated teeth)] × 100
Measured: 12 Months
Secondary outcomes (10)
Percentage of Mean Root Coverage
Percentage of root coverage will be calculated as: Percentage of root coverage: [(preoperative recession depth - postoperative recession depth) ÷ preoperative recession depth] × 100
Measured: 12 months
Recession depth
RD will be measured from the cemento-enamel junction (CEJ) to the gingival margin and reported in millimeters (mm).
Measured: 12 month
Probing depth
Probing depth will be measured from the gingival margin to the base of the sulcus and reported in millimeters (mm).
Measured: 12 months
Clinical attachment level
Clinical attachment level will be measured from the cemento-enamel junction to the sulcus base and reported in millimeters (mm).
Measured: 12 months
Keratinized gingiva width
KGW will be measured from the mucogingival junction to the gingival margin and reported in millimeters (mm).
Measured: 12 months
Gingival Thickness
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.
Measured: 12 months
Postoperative Pain assessed using a Visual Analog Scale (VAS)
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).
Measured: From the day of surgery through postoperative day 10 (11 days)
Dentin Hypersensitivity Score assessed using Air Stimulus (HSS)
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).
Measured: Baseline, 6 months, and 12 months
Pink Esthetic Score (PES) self-assessment
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).
Measured: Baseline, 6 months, and 12 months
Postoperative Analgesic Consumption
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.
Measured: From the day of surgery through postoperative day 10 (11 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Dec 2022
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival Recession, LocalizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Parallel-Group, Randomized, Controlled Clinical Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seyma Bozkurt Doğan, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07345520
- Sponsor's protocol ID
- 21.12.2022/12
- Status last verified
- Jan 2026
- First submitted
- 23 Nov 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07345520
- Acronym / sponsor ID
- 21.12.2022/12
- Conditions
- Gingival Recession, Localized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A Parallel-Group, Randomized, Controlled Clinical Trial
| Arm | Type | Receives |
|---|---|---|
| Volume Stable Collagen Matrix+Coronally Advanced Flap | Experimental | Biological: Volume-Stable Collagen MatrixThe 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. |
| Platelet-Rich Fibrin+Coronally Advanced Flap | Active comparator | Biological: Volume-Stable Collagen MatrixAutologous 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. |
| Subepithelial Connective Tissue Graft+Coronally Advanced Flap | Active comparator | Biological: Volume-Stable Collagen MatrixA subepithelial connective tissue graft harvested from the patient's palate and placed beneath a coronally positioned flap at the recipient site during periodontal surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- ≥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;
Key exclusion criteria (9 listed)
- smokers;
- caries/restorations/abrasions in the treated area, furcation involvement;
- contraindications to surgery;
- pregnancy or lactation;
- medications compromising healing;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Volume-Stable Collagen MatrixVolume-Stable Collagen Matrix | Biological | Platelet-Rich Fibrin+Coronally Advanced Flap, Subepithelial Connective Tissue Graft+Coronally Advanced Flap, Volume Stable Collagen Matrix+Coronally Advanced Flap |
Primary outcome
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
10 secondary outcomes
Percentage of Mean Root Coverage
Time frame: 12 months
Recession depth
Time frame: 12 month
Probing depth
Time frame: 12 months
Clinical attachment level
Time frame: 12 months
Keratinized gingiva width
Time frame: 12 months
Gingival Thickness
Time frame: 12 months
Postoperative Pain assessed using a Visual Analog Scale (VAS)
Time frame: 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
Pink Esthetic Score (PES) self-assessment
Time frame: Baseline, 6 months, and 12 months
Postoperative Analgesic Consumption
Time frame: From the day of surgery through postoperative day 10 (11 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
Related trials for Gingival Recession, Localized
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Recruiting
Palatal Wound Healing After Free Gingival Graft Harvest in Diabetic Patients: A Clinical Trial
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
Soft Tissue Augmentation, Gingival Recession Localized Moderate
Not yet recruiting
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
Diabetes Mellitus, Gingival Recession, Generalized
Not yet recruiting
Clinical and Histological Evaluation of Subepithelial Connective Tissue Graft Maturation at Different Healing Timepoints, With and Without Topical Application of a Polynucleotide- and Hyaluronic Acid-Based Gel
Gingival Recession, Generalized, Gingival Recession, Localized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Volume-Stable Collagen Matrix in people with Gingival Recession, Localized, run by Bulent Ecevit University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Complete Root Coverage (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.