Comparing two techniques for gum tissue grafting
Comparison of Free Gingival Graft and Linear Incision Techniques to Obtain Connective Tissue Graft in the Treatment of Multiple Gingival Recessions: a 12-month Non-inferiority Randomized Trial
This study is testing two different gum grafting techniques to see which one works better for covering exposed tooth roots in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Federal University of Rio Grande do Sul Academic / other |
| Locations | 1 site (Porto Alegre, RS) |
| Trial ID | NCT06365983 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a randomized controlled non-inferiority trial involving 24 healthy adults aged 18 or older who require root coverage for multiple gum recessions. Participants will undergo a bilateral root coverage procedure using two different grafting techniques: a free gingival graft on one side and a linear incision technique on the other. The study aims to evaluate the effectiveness of these two methods in achieving successful root coverage. Prior to the procedure, patients will receive oral hygiene instructions and preparatory dental care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with multiple RT1-type gum recessions requiring root coverage.
Not a fit: Patients with systemic conditions affecting healing, active periodontitis, or those who are current or ex-smokers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective technique for gum tissue grafting, improving patient outcomes in periodontal care.
How similar studies have performed: Other studies have explored similar grafting techniques, but this specific comparison is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients aged 18 or older requiring root coverage in bilateral multiple recessions involving at least two teeth on each side of the mouth will be included. The number of teeth to be covered must be equal on both sides to avoid imbalance in patient-centered comparisons. Recessions should be RT1 type according to the 2017 Workshop on the Classification of Periodontal Conditions and Diseases (Jepsen et al. 2018) and without non-carious cervical lesions. Exclusion Criteria: Individuals will not be considered eligible if they: * Present any form of immunological compromise; * Have diseases or systemic conditions contraindicating surgical procedures or affecting periodontal healing pattern, such as diabetes and autoimmune diseases; * Present active periodontitis, defined by presence of \>=10% subgingival bleeding and probing depth and clinical attachment loss proximal \>4mm (Tonetti et al. 2018); * Are current or ex-smokers; * Have allergies to ibuprofen and chlorhexidine digluconate.
Where this trial is running
Porto Alegre, RS
- Alex Nogueira Haas — Porto Alegre, Rs, Brazil (Recruiting)
Study contacts
- Study coordinator: Cássio Cardona Orth, Msc
- Email: cassio.orth@gmail.com
- Phone: 11999791876
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.