Gingival GraftNCT07918326
i-PRF-Based Bioactive Matrix vs. Connective Tissue Graft in the Treatment of Gingival Recessions
A study testing Coronally advanced flap and i-PRF based bioactive matrix and Coronally advanced flap and subepithelial connective tissue graft in people with Gingival Graft and Recession, Gingival, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
This study aims to evaluate the efficacy of a novel bioactive matrix, consisting of an equine collagen core soaked in i-PRF and wrapped in L-PRF, used in combination with a coronally advanced flap as an alternative to the autologous connective tissue graft for the treatment of gingival recessions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Graft, Recession, Gingival, Platelet Rich Fibrin
- What is being tested?
- Coronally advanced flap and i-PRF based bioactive matrix and Coronally advanced flap and subepithelial connective tissue graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteItaly
- Study dates
- 12 Feb 2024to 16 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Inclusion criteria Age ≥ 18 years Systemically healthy non-smokers Willingness to provide informed consent and attend the study No antibiotic use within the previous 3 months No known allergies to the materials used in the study No periodontal plastic surgery at the defect site within the previous 12 months Full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) ≤ 20% Miller Class I or II (RT1) buccal gingival recessions at maxillary or mandibular incisors, canines or premolars, single or multiple Recession depth ≥ 2 mm Exclusion criteria Unstable systemic diseases Compromised healing potential (e.g. diabetes) Active infectious diseases (hepatitis, tuberculosis, HIV, etc.) Use of steroid medications Pregnancy or attempting to become pregnant Use of medications known to cause gingival enlargement
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department of Innovative Technologies in Medicine and Dentistry, University 'G. D'Annunzio' of Chieti
Chieti, Chieti, 66100
Michele Paolantonio, DDS, MS, 08713554158, michelepaolantonio@gmail.com
About this study
Official title: Efficacy of a Novel i-PRF-based Bioactive Matrix in the Treatment of Gingival Recessions: a Randomized Controlled Clinical Trial
This study aims to evaluate the efficacy of a novel bioactive matrix, consisting of an equine collagen core soaked in i-PRF and wrapped in L-PRF, used in combination with a coronally advanced flap as an alternative to the autologous connective tissue graft for the treatment of gingival recessions. In this randomized controlled clinical trial, 24 patients with Miller Class I or II recessions will be treated with either the bioactive matrix (test) or a subepithelial connective tissue graft (control), with calibrated and blinded examiners. The primary endpoints are mean and complete root coverage at 6 months, while secondary outcomes include clinical parameters and patient-reported outcome measures (PROMs) on post-operative discomfort and satisfaction, recorded at baseline, 3 and 6 months.
- Conditions
- Gingival Graft, Recession, Gingival, Platelet Rich Fibrin
- Being tested
- Coronally advanced flap and i-PRF based bioactive matrix, Coronally advanced flap and subepithelial connective tissue graft
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally advanced flap and i-PRF based bioactive matrixBiological
An equine collagen matrix is trimmed to the size of the site, soaked in autologous i-PRF and wrapped in a double layer of L-PRF membranes. The resulting bioactive matrix is secured to the de-epithelialized papillae with simple interrupted sutures and fully covered by the flap.
Coronally advanced flap and subepithelial connective tissue graftProcedure or surgery
A free epithelialized gingival graft is harvested from the palate, de-epithelialized with a 15c blade and sutured at the level of the CEJ. The graft height is based on the distance from the CEJ to the buccal bone crest. The flap is then advanced to fully cover it.
| Study group | Role | What they receive |
|---|---|---|
| CAF+iPRF based Bioactive Matrix | Experimental | Coronally advanced flap (CAF) with a bioactive matrix (equine collagen soaked in i-PRF and wrapped in a double L-PRF membrane) Receives: Biological: Coronally advanced flap and i-PRF based bioactive matrix |
| CAF+SCTG | Active comparator | CAF with a de-epithelialized subepithelial connective tissue graft harvested from the palate Receives: Procedure: Coronally advanced flap and subepithelial connective tissue graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival thickness (GT)
Measured mid-buccally, 2 mm apical to the gingival margin, using a endodontic file with a rubber stopper
Measured: 3 months and 6 months
Mean root coverage (mRC)
percentage of baseline recession depth (RECd) covered
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study start12 Feb 2024
- Primary completion16 Feb 2028 (estimated)
- Study completion16 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gingival GraftStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michele Paolantonio, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918326
- Sponsor's protocol ID
- 10012024
- Status last verified
- Nov 2026
- First submitted
- 12 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Novel i-PRF-based Bioactive Matrix in the Treatment of Gingival Recessions: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07918326
- Acronym / sponsor ID
- 10012024
- Conditions
- Gingival Graft, Recession, Gingival, Platelet Rich Fibrin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 16 Feb 2028 (estimated)
- Study completion
- 16 Feb 2028 (estimated)
- First posted
- 5 Nov 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.
This study aims to evaluate the efficacy of a novel bioactive matrix, consisting of an equine collagen core soaked in i-PRF and wrapped in L-PRF, used in combination with a coronally advanced flap as an alternative to the autologous connective tissue graft for the treatment of gingival recessions. In this randomized controlled clinical trial, 24 patients with Miller Class I or II recessions will be treated with either the bioactive matrix (test) or a subepithelial connective tissue graft (control), with calibrated and blinded examiners. The primary endpoints are mean and complete root coverage at 6 months, while secondary outcomes include clinical parameters and patient-reported outcome measures (PROMs) on post-operative discomfort and satisfaction, recorded at baseline, 3 and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAF+iPRF based Bioactive Matrix | Experimental | Biological: Coronally advanced flap and i-PRF based bioactive matrixCoronally advanced flap (CAF) with a bioactive matrix (equine collagen soaked in i-PRF and wrapped in a double L-PRF membrane) |
| CAF+SCTG | Active comparator | Procedure: Coronally advanced flap and subepithelial connective tissue graftCAF with a de-epithelialized subepithelial connective tissue graft harvested from the palate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Coronally advanced flap and i-PRF based bioactive matrixAn equine collagen matrix is trimmed to the size of the site, soaked in autologous i-PRF and wrapped in a double layer of L-PRF membranes. The resulting bioactive matrix is secured to the de-epithelialized papillae with simple interrupted sutures and fully covered by the flap. | Biological | CAF+iPRF based Bioactive Matrix |
| Coronally advanced flap and subepithelial connective tissue graftA free epithelialized gingival graft is harvested from the palate, de-epithelialized with a 15c blade and sutured at the level of the CEJ. The graft height is based on the distance from the CEJ to the buccal bone crest. The flap is then advanced to fully cover it. | Procedure or surgery | CAF+SCTG |
Primary outcome
Gingival thickness (GT)
Time frame: 3 months and 6 months
Measured mid-buccally, 2 mm apical to the gingival margin, using a endodontic file with a rubber stopper
Mean root coverage (mRC)
Time frame: 3 months and 6 months
percentage of baseline recession depth (RECd) covered
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
Department of Innovative Technologies in Medicine and Dentistry, University 'G. D'Annunzio' of Chieti
Chieti, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally advanced flap and i-PRF based bioactive matrix and Coronally advanced flap and subepithelial connective tissue graft in people with Gingival Graft and Recession, Gingival, run by G. d'Annunzio University at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 5 Nov 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival thickness (GT) (time frame: 3 months and 6 months). The study lists 2 primary outcomes in all. 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 5 Nov 2026.