Palatal Shield Technique for Graft Donor Site Healing

NCT07089433 | Completed DMC

• 1 other identifier: Palatal Shield
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Palatal Wound

Keywords

Free gingival graft; Wound healing; palatal stent

Outcome Measures

Primary Outcomes (3)

• Postoperative Pain

  Measured daily using a Visual Analog Scale (VAS) during the first postoperative week.

  The day of the intervention and every day for the first week

• General Patient Comfort

  Evaluated using standardized questionnaires assessing discomfort during daily activities such as eating and oral hygiene

  The day of the intervention, every day during the first week and 14 days after the intervention

• Patient Satisfaction

  Assessed using Likert scales and validated questionnaires

  The day of the intervention, every day during the first week and 14 days after the intervention

Secondary Outcomes (5)

• Clinical Healing of Donor Site

  At 7 and 14 days postoperatively.

• Postoperative Complications

  Every day during the first week

• Analgesic Use

  Day of the intervention and every day during the first week.

• Functional Recovery Time

  Every day during the first week and at day 14

• Oral Health-Related Quality of Life

  At day 14

Study Arms (2)

Test

EXPERIMENTAL

The palatal wound will be protected with composite resin

Procedure: Palatal stent as wound dressing

Control

ACTIVE COMPARATOR

The palatal wound will be covered with collagen sponge

Procedure: Conventional suturing

Interventions

Palatal stent as wound dressing PROCEDURE

The palatal wound after graft harvesting will be protected with a flowable composite resin adhesively secured to adjacent teeth

Test

Conventional suturing PROCEDURE

The wound will be covered with a collagen sponge that will be hold in place with sutures

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (≥18 years old) requiring periodontal or peri-implant mucogingival surgery involving palatal graft harvesting.
• Systemically healthy patients without medical conditions affecting wound healing.
• Patients free of active periodontal disease at the time of surgery.
• Patients able and willing to comply with postoperative instructions, complete questionnaires, and attend follow-up appointments.
• Patients providing informed written consent to participate in the study.

You may not qualify if:

• Patients with systemic diseases that could influence wound healing (e.g., diabetes, autoimmune disorders).
• Patients with active periodontal disease.
• Patients taking medications known to affect bleeding or healing (e.g., anticoagulants, immunosuppressants, steroids).
• Patients who are pregnant or breastfeeding.
• Patients who have undergone previous surgical interventions in the palatal donor area.
• Patients with allergies or hypersensitivity to composite resin materials or collagen-based products.
• Patients unable or unwilling to comply with postoperative instructions or follow-up visits.
• Patients with poor oral hygiene or uncontrolled plaque accumulation.

Sponsors & Collaborators

• University of Cagliari: lead

Study Sites (1)

Cagliari University Hospital

Cagliari, Cagliari, 09042, Italy

Location

MeSH Terms

Interventions

Bandages

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 20, 2025
• First Posted: July 28, 2025
• Study Start: July 1, 2023
• Primary Completion: April 30, 2025
• Study Completion: July 15, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)