Gingival RecessionNCT05819515
Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix
A study testing Tunneled coronally advanced flap in people with Gingival Recession, run by University of Michigan at 1 site in United States.
Trial summary
The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft. 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
- What is being tested?
- Tunneled coronally advanced flap
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2023to 27 Mar 2024
- Phase
- Interventional
- 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
- Periodontally and systemically healthy adults
- Full-mouth plaque score and full-mouth bleeding score ≤ 20%
- Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage
- No interproximal attachment/bone loss
- No prior experience of root coverage procedures within the last 1 year
- The patient must be able to perform good oral hygiene
Who cannot join
- Contraindications for undergoing periodontal surgery
- Teeth with more than Grade II mobility, or furcation involvement of Class III
- Patients pregnant or attempting to get pregnant (self-reported), or nursing women
- Untreated/active periodontitis, or other untreated acute infections at the surgical site
- Untreated malignancies at the surgical site
- Persistence of uncorrected gingival trauma from traumatic toothbrushing
Show all 11Show fewer
- Presence of severe tooth malposition, rotation or clinically significant super-eruption
- Self-reported current smoking more than 10 cigarettes/day or pipe or cigar smoking, or active tobacco chewing, or chronic vaping
- Patients with any known history of blood disorders or complications such as abnormal concentration of thrombin and factor XIII in plasma, or hemophilia
- Patients with significant co-morbidities, such as obesity, uncontrolled diabetes, immunosuppression, severe endocrine-induced bone diseases, signs of malnourishment, those receiving immunosuppressive therapy, poor tissue oxygenation or perfusion, and pre- or post-operative radiation
- Patients with known sensitivity to Polysorbate 20, Cefoxitin, Lincomycin, polymyxin B, Vancomycin
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan - Ann Arbor
Ann Arbor, Michigan, 48109
About this study
Official title: Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix, Compared to the Connective Tissue Graft: A Parallel-arm, Randomized, Controlled, Assessor-blind, Non-inferiority Clinical Trial
The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.
Read the detailed description
Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.
- Conditions
- Gingival Recession
- Being tested
- Tunneled coronally advanced flap
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tunneled coronally advanced flapProcedure or surgery
Describes the flap design for both treatment arms
| Study group | Role | What they receive |
|---|---|---|
| Connective Tissue Graft | Active comparator | A connective tissue graft from the patient's palate will be used Receives: Procedure: Tunneled coronally advanced flap |
| Allogenic Dermal Matrix with Platelet-Rich Fibrin | Experimental | An allogenic dermal matrix with the patient's platelet-rich fibrin will be used Receives: Procedure: Tunneled coronally advanced flap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean root coverage (mRC)
Measured as a percentage of the total baseline recession defect that coverage was obtained at.
Measured: Assessed at 6 months
Complete root coverage (CRC)
Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect
Measured: Assessed at 6 months
Keratinized tissue (KT) gain
Measured in mm
Measured: Assessed at 6 months
Gingival thickness (GT) gain
Measured in mm
Measured: Assessed at 6 months
Patient-reported outcomes (PROMs)
In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).
Measured: Measured from the day of the procedure up to a maximum of 1 month
Duration of surgical procedure
Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.
Measured: During surgery
Secondary outcomes (7)
Professionally evaluated esthetic score
Assessed using the Root coverage Esthetic Score (RES) system (from 0 lowest, to 10 highest)
Measured: Assessed at 6 months
Soft tissue volume changes over time
Assessed using 3D scanner imaging in the units of mm
Measured: Changes of from baseline (prior to treatment) compared with 3 and 6 months
Soft tissue volume changes over time
Assessed using dental ultrasonography in the units of mm
Measured: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Soft tissue blood flow changes over time
Assessed and quantified using dental ultrasonography
Measured: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Patient-reported esthetics
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Measured: Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results
Patient-reported satisfaction
Based on a visual analogue scale (VAS), measured as numbers from 0 (lowest) to 10 (highest).
Measured: Measured at 6 months to provide the satisfaction score in VAS scale
Patient-reported post-operative pain as measured with a mobile application
Measured using a mobile application at the recession grafted site, the donor site on the palate, and the donor site for the venopuncture.
Measured: From the day of the procedure until 1 month after the surgical time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start29 Apr 2023
- Primary completion27 Mar 2024
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gingival RecessionStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS MSD PhD, Principal investigator, University of MichiganShayan Barootchi, DMD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05819515
- Sponsor's protocol ID
- HUM00214311
- Status last verified
- Oct 2026
- First submitted
- 21 Mar 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.
PubMed 35175005Barootchi S, Giannobile WV, Tavelli L. PDGF-BB-enriched collagen matrix to treat multiple gingival recessions with the tunneled coronally advanced flap. Clin Adv Periodontics. 2022 Dec;12(4):224-232. doi: 10.1002/cap.10211. Epub 2022 Oct 24.
PubMed 35665500Tavelli L, Barootchi S. A Minimally Invasive Approach for the Treatment of Multiple Adjacent Gingival Recessions with a Volume-Stable Collagen Matrix: A Case Series. Int J Periodontics Restorative Dent. 2022 Mar-Apr;42(2):155-162. doi: 10.11607/prd.5747.
PubMed 35353081
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Gingival Recession Defects Using Platelet-Rich Fibrin With an Allogenic Dermal Matrix, Compared to the Connective Tissue Graft: A Parallel-arm, Randomized, Controlled, Assessor-blind, Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT05819515
- Acronym / sponsor ID
- HUM00214311
- Conditions
- Gingival Recession
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 27 Mar 2024 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 19 Apr 2023 (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.
The study aims to test the non-inferiority of an Allogenic Dermal Matrix with Platelet-Rich Fibrin for treatment of gingival recessions in comparison to the Connective Tissue Graft.
Detailed description
Currently the Connective Tissue Graft (CTG) is referred to as the gold standard in terms of the grafting material for the treatment of gingival recession defects. This study test the non-inferiority of the Allogenic Dermal Matrix (ADM) with Platelet-Rich Fibrin (PRF) to that of the CTG, in terms of the amount of root coverage obtained after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Connective Tissue Graft | Active comparator | Procedure: Tunneled coronally advanced flapA connective tissue graft from the patient's palate will be used |
| Allogenic Dermal Matrix with Platelet-Rich Fibrin | Experimental | Procedure: Tunneled coronally advanced flapAn allogenic dermal matrix with the patient's platelet-rich fibrin will be used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Periodontally and systemically healthy adults
- Full-mouth plaque score and full-mouth bleeding score ≤ 20%
- Presence of at least one 3 mm or deeper gingival recession, with at least 1.5 mm of Keratinized tissue, and 1 mm of gingival thickness) requiring surgical intervention for root coverage
- No interproximal attachment/bone loss
- No prior experience of root coverage procedures within the last 1 year
Key exclusion criteria (11 listed)
- Contraindications for undergoing periodontal surgery
- Teeth with more than Grade II mobility, or furcation involvement of Class III
- Patients pregnant or attempting to get pregnant (self-reported), or nursing women
- Untreated/active periodontitis, or other untreated acute infections at the surgical site
- Untreated malignancies at the surgical site
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 |
|---|---|---|
| Tunneled coronally advanced flapDescribes the flap design for both treatment arms | Procedure or surgery | Allogenic Dermal Matrix with Platelet-Rich Fibrin, Connective Tissue Graft |
Primary outcome
Mean root coverage (mRC)
Time frame: Assessed at 6 months
Measured as a percentage of the total baseline recession defect that coverage was obtained at.
Complete root coverage (CRC)
Time frame: Assessed at 6 months
Measured as a percentage of total treated sites, that obtained a full coverage of the recession defect
Keratinized tissue (KT) gain
Time frame: Assessed at 6 months
Measured in mm
Gingival thickness (GT) gain
Time frame: Assessed at 6 months
Measured in mm
Patient-reported outcomes (PROMs)
Time frame: Measured from the day of the procedure up to a maximum of 1 month
In terms of pain/discomfort at the palatal donor site or patient's arm. Measured using a scale from 0 (lowest) to 10 (highest).
Duration of surgical procedure
Time frame: During surgery
Including the length of surgical procedure, drawing of blood, and preparation of PRF, harvesting of the autogenous CTG. Measured in minutes.
7 secondary outcomes
Professionally evaluated esthetic score
Time frame: Assessed at 6 months
Soft tissue volume changes over time
Time frame: Changes of from baseline (prior to treatment) compared with 3 and 6 months
Soft tissue volume changes over time
Time frame: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Soft tissue blood flow changes over time
Time frame: Measured throughout the study to assess changes from immediate post-op (right after the completion of surgical appointment) until the final recall at 6 months
Patient-reported esthetics
Time frame: Measured at baseline and at 6 months, and compared between these time points to provide subjective esthetic results
Patient-reported satisfaction
Time frame: Measured at 6 months to provide the satisfaction score in VAS scale
Patient-reported post-operative pain as measured with a mobile application
Time frame: From the day of the procedure until 1 month after the surgical time point
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 16 Oct 2026.
- Background: PubMed 35175005Barootchi S, Tavelli L. Tunneled coronally advanced flap for the treatment of isolated gingival recessions with deficient papilla. Int J Esthet Dent. 2022 Feb 17;17(1):14-26.
- Background: PubMed 35665500Barootchi S, Giannobile WV, Tavelli L. PDGF-BB-enriched collagen matrix to treat multiple gingival recessions with the tunneled coronally advanced flap. Clin Adv Periodontics. 2022 Dec;12(4):224-232. doi: 10.1002/cap.10211. Epub 2022 Oct 24.
- Background: PubMed 35353081Tavelli L, Barootchi S. A Minimally Invasive Approach for the Treatment of Multiple Adjacent Gingival Recessions with a Volume-Stable Collagen Matrix: A Case Series. Int J Periodontics Restorative Dent. 2022 Mar-Apr;42(2):155-162. doi: 10.11607/prd.5747.
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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.
Hom-Lay Wang, DDS MSD PhD principal investigator
University of Michigan
Shayan Barootchi, DMD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tunneled coronally advanced flap in people with Gingival Recession, run by University of Michigan at 1 site in United States.
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 6 inclusion and 11 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 16 Oct 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 United States. 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.
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?
Mean root coverage (mRC) (time frame: Assessed at 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05819515, which also lists 3 linked publications.
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 16 Oct 2026.