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.
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.
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;
Parallel
Suture
Procedure/SurgeryHemostatic 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).
Cyanoacrylate bioadhesive
Procedure/SurgerySeveral 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.
Postoperative pain
Minimum and maximum values \[0-100\] Higher scores mean worse outcome (more pain) A questionnaire will be prepared and handed to patients on the day of the surgery. Patients will be instructed to answer the questions at the same time of the day and refer only to the palatal wound. Postoperative pain will be assessed using a Visual Analog Score (VAS) at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks postoperatively.
Postoperative bleeding
YES/NO question, Yes meaning there is bleeding A questionnaire will be prepared and handed to patients on the day of the surgery. Patients will be instructed to answer the questions at the same time of the day and refer only to the palatal wound. Post-operative bleeding will be assessed dichotomously (YES/NO) at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks.
Discomfort at eating
Minimum and maximum values \[0-100\] Higher scores mean worse outcome (more discomfort) A questionnaire will be prepared and handed to patients on the day of the surgery. Patients will be instructed to answer the questions at the same time of the day and refer only to the palatal wound. Discomfort at eating will be assessed by using a VAS at 1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks postoperatively.
Analgesic consumption
Number of Ibuprofen pills taken during the first week postoperatively Higher number means worse outcome (more painkillers) A questionnaire will be prepared and handed to patients on the day of the surgery. Patients will be instructed to answer the questions at the same time of the day and refer only to the palatal wound. Analgesic consumption (n) will be reported during the first week postoperatively.
Oral Health Impact Profile 5 questionnaire (OHIP5)
At the final follow-up visit (8 weeks), patients will be handed an Oral Health Impact Profile 5 questionnaire (OHIP5) to assess the influence of the intervention on their quality of life. The Spanish version of the validated OHIP5 consists of the following questions: Have you had difficulty biting food because of problems with your teeth, mouth, or dentures? Have you had painful discomfort in your mouth? Have you felt discomfort about the appearance of your teeth, mouth, or dentures? Have you noticed less taste in your food because of problems with your teeth, mouth, or dentures? Have you had difficulty doing your usual work because of problems with your teeth, mouth, or dentures? Responses will be marked on the following scale: 0-never; 1-hardly ever; 2 occasionally; 3-fairly often; and 4-very often.
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