Treatment of gum recession using a new collagen matrix
Use of a Novel Volume-stable Collagen Matrix (VCMX) in the Treatment of Single Gingival Recession Associated With Non-carious Cervical Lesion Partially Restored. A Randomized Clinical Trial
This study is testing a new collagen treatment for gum recession to see if it works better than standard methods for adults with certain types of gum issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 60 Years |
| Sex | All |
| Sponsor | Universidade Estadual Paulista Júlio de Mesquita Filho Academic / other |
| Locations | 1 site (São José Dos Campos, SP) |
| Trial ID | NCT05916716 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a novel volume-stable collagen matrix (VCMX) in treating single gingival recession associated with non-carious cervical lesions. The approach combines a restorative procedure with a coronally advanced flap (CAF) and the application of VCMX, alongside antibiotics like amoxicillin. The study aims to assess the outcomes of this method compared to traditional treatments, focusing on both aesthetic and functional results. Eligible participants are adults with specific types of gum recession and no active periodontal disease.
Who should consider this trial
Good fit: Ideal candidates are adults over 20 years old who are systemically healthy and have specific types of gum recession without active periodontal disease.
Not a fit: Patients who have had prior periodontal surgery in the affected area, smokers, or those undergoing orthodontic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and less invasive option for patients suffering from gum recession and associated dental issues.
How similar studies have performed: While there is limited research on this specific approach, previous studies have shown promise in using biomaterials for similar dental conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * adult \> 20 years old; * systemically healthy * no signs of active periodontal disease; * full-mouth plaque and bleeding score ≤20%; * Gingival recession type RT1 associated with NCCL B+ on a vital canine or premolar; Exclusion Criteria: * Patients who had had periodontal surgery on the study area; * Smokers patients; * Pregnant or lactating patients; * Ongoing orthodontic treatment; * Patients taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure
Where this trial is running
São José Dos Campos, SP
- Sao Paulo State University — São José Dos Campos, Sp, Brazil (Recruiting)
Study contacts
- Study coordinator: Mauro P Santamaria, PhD
- Email: mauro.santamaria@unesp.br
- Phone: (12) 39479055
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.