NCT07089433

Palatal Shield Technique for Graft Donor Site Healing

Completed NA Last updated 28 July 2025

What this trial tests

NA trial testing Palatal stent as wound dressing in Palatal Wound in 20 participants. Completed in 15 July 2025.

Timeline

1 July 2023

Primary endpoint
30 April 2025

15 July 2025

Quick facts

Lead sponsor	University of Cagliari
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	supportive care
Enrollment	20
Start date	1 July 2023
Primary completion	30 April 2025
Estimated completion	15 July 2025
Sites	1 location across Italy

Drugs / interventions tested

• Palatal stent as wound dressing
• Conventional suturing

Conditions studied

• Palatal Wound — all drugs for Palatal Wound →

Sponsor

University of Cagliari

Who can join

Eligibility, any sex, with Palatal Wound. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This randomized clinical trial aims to compare two techniques for managing the palatal donor site following gingival graft harvesting: a palatal stent made of flowable composite resin versus conventional suturing. The primary goal is to identify which method provides superior patient-reported outcomes (PROMs), thus optimizing postoperative comfort and overall patient well-being.

Systemically healthy patients, free of active periodontitis, requiring a palatal graft as part of periodontal or peri-implant mucogingival surgeries will be recruited and randomized into two groups. The experimental group will receive a palatal shield made of flowable composite resin adhesively secured to adjacent teeth, whereas the control group will undergo conventional suturing. In both groups, a collagen hemostatic sponge will be placed to aid hemostasis.

Primary endpoints include postoperative pain measured daily via Visual Analog Scale (VAS), general patient comfort during daily activities such as eating and oral hygiene, and overall patient satisfaction assessed using Likert scales or validated questionnaires.

Secondary endpoints involve clinical healing evaluated clinically and photographically at 7 and 14 days postoperatively, incidence of postoperative complications (e.g., prolonged bleeding, infections), analgesic consumption, functional recovery time, and oral health-related quality of life measured by the OHIP-14 questionnaire.

Statistical analysis will compare groups using appropriate parametric or non-parametric tests for continuous variables (pain scores, recovery time) and Chi-square or Fisher's exact tests for categorical variables. Pain progression over time will be assessed using repeated-measures ANOVA or an equivalent non-parametric test.

This study will help determine whether the palatal stent represents a superior alternative to conventional techniques in improving patient comfort, healing, and postoperative oral health-related quality of life in mucogingival surgical procedures.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.