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Palatal Shield Technique for Graft Donor Site Healing

NCT07089433 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-28

No results posted yet for this study

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

Interventions

PROCEDURE

Palatal stent as wound dressing

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

PROCEDURE

Conventional suturing

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

Sponsors & Collaborators

  • University of Cagliari

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-01
Primary Completion
2025-04-30
Completion
2025-07-15

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089433 on ClinicalTrials.gov