Using a collagen matrix to treat single gum recession
Functionalization of a Volume-stable Collagen Matrix (VCMX) Using Injectable Platelet Rich Fibrin (i-PRF) for the Treatment of Single Gingival Recession
This study is testing a new way to treat gum recession using a special collagen matrix and platelet-rich fibrin to see if it helps people heal better with less pain and fewer complications than traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universidade Estadual Paulista Júlio de Mesquita Filho Academic / other |
| Locations | 1 site (São José Dos Campos, São Paulo) |
| Trial ID | NCT05916742 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a volume-stable collagen matrix biofunctionalized with injectable platelet-rich fibrin (i-PRF) as an alternative to traditional connective tissue grafts for treating single gingival recessions. The goal is to enhance the healing process while minimizing complications such as bleeding and postoperative pain. Participants will undergo a coronally advanced flap procedure combined with the collagen matrix and i-PRF to assess the effectiveness of this innovative approach. The study aims to improve patient acceptance and outcomes in periodontal surgery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a single gingival recession on vital canines or premolars, experiencing dentin hypersensitivity or aesthetic concerns.
Not a fit: Patients who smoke, are pregnant, or have contraindications for periodontal surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more effective treatment option for patients with gingival recession.
How similar studies have performed: Other studies have shown promising results with similar biofunctionalized collagen matrices, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Presence of RT1 (Cairo et al., 2011) buccal single gingival recession (GR) on vital upper or lower canines and premolars with intact root surface (visible CEJ). * Presence of dentin hypersensitivity (HD) and/or esthetic concerns related to GR. * Adults \> 18 years old. * Systemically health. * No signs of active periodontal disease. * Full-mouth plaque and bleeding score ≤ 20%. * Written informed consent given. Exclusion Criteria: * Smoking. * Contraindication for periodontal surgery. * Pregnancy. * Presence of orthodontic braces. * Medications known to interfere with periodontal healing. * Use of anticoagulants.
Where this trial is running
São José Dos Campos, São Paulo
- São Paulo State University — São José Dos Campos, São Paulo, Brazil (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.