Wound Healing and Patient-Reported Outcomes After Gingival Graft Harvesting From the Palate
Wound Healing and Patient-Reported Outcomes After Autogenous Gingival Graft Harvesting From the Palate: A Randomized Controlled Clinical Trial
Universitat Internacional de Catalunya
66 participants
Feb 3, 2025
INTERVENTIONAL
Conditions
Summary
The goal of this clinical trial is to evaluate whether two different techniques for treating palatal wounds-sutures and cyanoacrylate bioadhesive-can influence postoperative morbidity, clinical healing, and soft tissue dimensional changes in patients undergoing epithelialized gingival graft harvesting from the palate. The main questions it aims to answer are: Does the use of cyanoacrylate bioadhesive reduce postoperative morbidity compared to sutures? Does the choice of wound treatment technique affect clinical healing and three-dimensional changes in soft tissues? Researchers will compare the sutures (control group) to the cyanoacrylate bioadhesive (test group) to determine if the bioadhesive leads to improved postoperative outcomes. Participants will: Undergo epithelialized gingival graft harvesting from the palate. Receive either sutures or cyanoacrylate bioadhesive for wound closure. Be monitored for postoperative morbidity, clinical healing, and soft tissue dimensional changes.
Eligibility
Inclusion Criteria4
- 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 Criteria6
- 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.
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Interventions
Hemostatic sutures at the palatal donor site; 5-0 non-resorbable suspensory mattress sutures will be anchored to the soft tissues apical to the palatal wound area (5-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA).
Several drops of a high-viscosity cyanoacrylate bioadhesive will be applied (Cuantum Oral Adhesive, Cuantum Medical Cosmetics S.L., Spain) to create a uniform adhesive layer.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06806111