Evaluating ways to protect the palate after gum graft removal
Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial
This study is testing different ways to protect the mouth after gum surgery to see which method helps with healing and pain for patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT06892496 on ClinicalTrials.gov |
What this trial studies
This study evaluates different techniques for protecting the palate after harvesting a soft-tissue graft for periodontal surgery. It aims to assess patient-reported outcome measures (PROMs) related to healing and pain using various protective methods, including a vacuum-formed retainer, a 3D printed acrylic resin stent, and a flowable resin composite stent. Additionally, the study will analyze the healing of palatal tissue through photographic and 3D volumetric changes, as well as the time required for fabrication and adjustments of each technique.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with healthy or mildly controlled systemic diseases requiring soft-tissue grafting.
Not a fit: Patients with systemic conditions that impair wound healing, such as diabetes or those undergoing chemotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved healing and reduced pain for patients undergoing gum graft procedures.
How similar studies have performed: While similar studies have explored post-operative care techniques, this specific approach to palatal protection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age * Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II) * Sites with 1 to 3 teeth or implants requiring soft-tissue grafting * Minimum palatal thickness of 2 mm * Willing to participate and sign an informed consent Exclusion Criteria: * Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.) * Pregnant patients * Patients with bleeding disorders or taking anticoagulants * Smokers * Patients with a history of palatal graft harvesting
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Rafael Amorim Cavalcanti de Siqueira — Virginia Commonwealth University
- Study coordinator: Rafael Amorim Cavalcanti de Siqueira
- Email: amorimcavalr@vcu.edu
- Phone: 8046288377
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.