Wound Healing and Patient-Reported Outcomes After Gingival Graft Harvesting From the Palate

NCT06806111 | Recruiting DMC

• 1 other identifier: PER-ECL-2024-10
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Palatal Wound

Keywords

gingival graft harvesting; wound healing agent; postoperative pain; palatal healing; palatal volumetric changes

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks

Secondary Outcomes (11)

• Postoperative bleeding

  1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks.

• Discomfort at eating

  1 day, 3 days, 1 week, 2 weeks, 3 weeks, and 4 weeks

• Analgesic consumption

  during the first week

• Oral Health Impact Profile 5 questionnaire (OHIP5)

  At 8 weeks

• Epithelial gingival graft dimensions

  Per-operatively

Study Arms (2)

Suture

ACTIVE COMPARATOR

This is the control group. In this group, 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).

Procedure: Suture

Cyanoacrylate bioadhesive

EXPERIMENTAL

This is the test group. In this group, 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. No sutures will be placed.

Procedure: Cyanoacrylate bioadhesive

Interventions

Suture PROCEDURE

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).

Suture

Cyanoacrylate bioadhesive PROCEDURE

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.

Cyanoacrylate bioadhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitat Internacional de Catalunya: lead

Study Sites (1)

Clínica Universitària d'Odontologia - UIC Barcelona

Barcelona, Sant Cugat Del Valles, 08195, Spain

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Sutures

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Central Study Contacts

Lory Abrahamian, DDS, MSc, PhD Candidate

CONTACT

+34722528012; lory.abrahamian@uic.es

Gonzalo Blasi, DDS, MS, PhD

CONTACT

+34620387688; gonzaloblasi@uic.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 3, 2025
• Study Start: February 3, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: After publishing
• Access Criteria: Researchers must submit a formal data request outlining the purpose of their study, the specific data required, and the intended use.

Locations

ES (1)