An interventional study of Coronally advanced flap and i-PRF based bioactive matrix and Coronally advanced flap and subepithelial connective tissue graft in Gingival Graft, Recession, Gingival and Platelet Rich Fibrin, sponsored by G. d'Annunzio University. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by G. d'Annunzio University · Not applicable, Interventional, and Treatment
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.
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 48 is above the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →G. d'Annunzio University is the lead sponsor of 67 studies on the registry; 22 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria Age ≥ 18 years Systemically healthy non-smokers Willingness to provide 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, , etc.) Use of medications Pregnancy or attempting to become pregnant Use of medications known to cause gingival enlargement
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Coronally advanced flap (CAF) with a bioactive matrix (equine collagen soaked in i-PRF and wrapped in a double L-PRF membrane)
Biological: Coronally advanced flap and i-PRF based bioactive matrix
CAF with a de-epithelialized subepithelial connective tissue graft harvested from the palate
Procedure: Coronally advanced flap and subepithelial connective tissue graft
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.
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.
Gingival thickness (GT)
Measured mid-buccally, 2 mm apical to the gingival margin, using a endodontic file with a rubber stopper
Time frame: 3 months and 6 months
Mean root coverage (mRC)
percentage of baseline recession depth (RECd) covered
Time frame: 3 months and 6 months
Started Feb 2024 (actual). Primary completion is estimated for Feb 2028, 48 months after the start.
Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 48 months is above that.
Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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G. d'Annunzio University