Healing and comfort after taking a gum graft from the palate
Wound Healing and Patient-Reported Outcomes After Autogenous Gingival Graft Harvesting From the Palate: A Randomized Controlled Clinical Trial
This trial will test whether using a cyanoacrylate bioadhesive instead of sutures to close the palate donor site reduces pain and improves healing in adults having a gingival graft taken from the palate.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 66 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitat Internacional de Catalunya Academic / other |
| Locations | 1 site (Barcelona, Sant Cugat Del Valles) |
| Trial ID | NCT06806111 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial compares two wound-closure techniques—traditional sutures versus a cyanoacrylate bioadhesive—after epithelialized gingival graft harvesting from the palate. Participants will be followed for postoperative morbidity, clinical healing, patient-reported pain and eating discomfort, bleeding, analgesic use, and three-dimensional soft-tissue volumetric changes. Investigators will also look for correlations between healing dynamics and patient factors such as anatomy, demographics, and surgical variables. The trial is conducted at the Clínica Universitària d'Odontologia, UIC Barcelona, with standardized clinical and imaging assessments.
Who should consider this trial
Good fit: Adults over 18 who are systemically healthy, have healthy periodontal status (FMPS and FMBS ≤ 20%), and have no prior soft tissue harvesting are the intended candidates.
Not a fit: People with diabetes or other metabolic diseases, heavy smokers (≥10 cigarettes/day), those on medications that impair healing, pregnant or lactating individuals, patients with removable maxillary prostheses, or those in active orthodontic therapy are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the bioadhesive approach could lower postoperative pain and bleeding, reduce analgesic use, and speed or improve palatal wound healing compared with sutures.
How similar studies have performed: Smaller studies and reports in oral surgery have shown tissue adhesives can reduce bleeding and discomfort, but high-quality randomized data specifically for palatal donor-site healing are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Systemically healthy individuals older than 18 years old; * Healthy periodontal status according to the AAP/EFP definition; * Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%; * No history of soft tissue harvesting. Exclusion Criteria: * Pregnancy or lactation; * Self-reported smoking ≥10 cigarettes/day; * Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus); * Any medication that may interfere with wound healing; * Removable maxillary prostheses; * Ongoing orthodontic therapy.
Where this trial is running
Barcelona, Sant Cugat Del Valles
- Clínica Universitària d'Odontologia - UIC Barcelona — Barcelona, Sant Cugat Del Valles, Spain (Recruiting)
Study contacts
- Study coordinator: Lory Abrahamian, DDS, MSc, PhD Candidate
- Email: lory.abrahamian@uic.es
- Phone: +34722528012
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.