Volume-stable collagen matrix vs graft for multiple gingival recessions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial compares a volume-stable xenogeneic collagen matrix used with a coronally advanced flap to the standard autogenous subepithelial connective tissue graft with a coronally advanced flap for treating multiple gingival recessions. Participants are adults with at least two Cairo RT1 recessions and 2 mm or more of recession depth, recruited at the University of São Paulo's Ribeirão Preto campus. Primary endpoint is change in gingival recession depth from baseline to 12 months; secondary endpoints include keratinized tissue width, probing depth, clinical attachment level, gingival thickness, root coverage percentage, esthetic outcomes, dentin hypersensitivity, postoperative comfort, and patient satisfaction, assessed via clinical measurements, patient-reported outcomes, photographs, and digital volumetric analysis. The trial aims to determine if the collagen matrix provides comparable root coverage with potentially less donor-site morbidity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 years or older.
* Presence of at least two Cairo RT1 gingival recessions in anterior teeth and/or premolars.
* Gingival recession depth greater than or equal to 2 mm.
* Presence of at least 2 mm of keratinized gingiva apical to the gingival recession.
* Indication for root coverage treatment due to esthetic concern and/or dentin hypersensitivity.
* Sites with non-carious cervical lesions may be included if they are previously restored and, after restoration, present residual gingival recession greater than or equal to 2 mm.
* Good plaque control, defined as full-mouth plaque score and full-mouth marginal gingival bleeding score below 20%.

Exclusion Criteria:

* Current smokers or individuals who stopped smoking less than 12 months before enrollment.
* Decompensated systemic diseases.
* Pregnancy or lactation.
* Active periodontal disease.
* Untreated root caries.
* Previous mucogingival surgery in the study area.

Where it's running

• School of Dentistry of Ribeirão Preto, University of Sao Paulo
  Ribeirão Preto, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Arthur Belem Novaes Jr, DDS, PhD — University of Sao Paulo
• Study coordinator: Edgar Daniel Vargas Quiroga, DDS, MSc
• Email: edgar.vargasquiroga@usp.br
• Phone: +551633153000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.