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NCT Number: NCT06892496

Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques

This study has been initiated to evaluate the question, "What is the best way to protect the palate after a gum graft is removed?" The overall objective is to determine if there is a difference in PROMs of donor site healing using different palatal post-operative protection techniques.

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Key information

Conditions

Mucosal Erosion Gingival Diseases Gingival Recession Mouth Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Periodontal Atrophy Periodontal Diseases Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

This study aims to determine if there is a difference in subject-reported outcome measures (PROMs) when different palatal post-operative protection techniques are used during healing after an autogenous soft-tissue graft is harvested from the palate for periodontal and peri-implant plastic surgery. The secondary objective is to evaluate if there is a difference in the healing of the palatal tissue via photographic and 3D linear and volumetric changes analysis after using the different protective techniques. Furthermore, the study will evaluate the time needed for fabrication and intraoral adjustment of each protective barrier and professional preference among the techniques utilized.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years of age
  • Healthy or Mild controlled systemic diseases with no functional limitations (ASA I or ASA II)
  • Sites with 1 to 3 teeth or implants requiring soft-tissue grafting
  • Minimum palatal thickness of 2 mm
  • Willing to participate and sign an informed consent

Exclusion criteria

  • Patients with systemic conditions that could impair wound healing (i.e. diabetes, immunosuppressive, chemotherapy, etc.)
  • Pregnant patients
  • Patients with bleeding disorders or taking anticoagulants
  • Smokers
  • Patients with a history of palatal graft harvesting

Treatment and study plan

Visual Analog scale (VAS) questionnaire

Other

A Visual Analog Scale (VAS) questionnaire is a type of self-report tool where respondents mark a point on a continuous line to indicate the intensity of a subjective experience, like pain, fatigue, or happiness, between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale; essentially, it measures the degree of a symptom along a visual continuum.

Vacuum-formed retainer (VFR) technique

Other

On the day of surgery, the stent will be positioned to cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. Vacuum-formed retainers are a common clinical practice used after harvesting a palatal graft, in order to provide a mechanical barrier to reduce post-operative pain.

3-D printed acrylic resin stent (3DS) technique

Other

On the day of surgery, the previously made palatal stent (3DS) will be placed in position and stabilized by mechanical retention in the palate and palatal surface of the maxillary teeth, bilaterally.

Flowable resin composite stent (FRC) technique

Other

On the day of surgery, a layer of flowable composite will be added, covering all the wound dimensions, restricted to the wound (no extension to the adjacent teeth). Flowable composite has been shown to help reduce pain using the same principal of providing a mechanical barrier to protect the palatal wound from the oral cavity

Photographs of the patient's palate

Other

At the 14-day, 30-day and 3-month follow-up visits, photographs of the patient's palate (Canon EOS 60D DSLR, Canon, USA) will be taken for healing evaluation as well as intraoral scans (TRIOS 4, 3Shape) of the palatal wound for linear and volumetric changes analysis.

Measuring graft dimensions

Other

The graft dimensions will be measured with the use of a periodontal probe and recorded on the data collection form. The professional preference in regard to technique applied and the time spent by the surgeon to adjust the stent intraorally will also be recorded in the same form.

Chairside Polymer Stent

Other

The stent will be placed directly in the roof of the mouth. Instructions will be provided to the patient about how to remove, place and clean the stent. The patients will be instructed to wear the stent for the first 3 days and per their personal preference on the 4th day and after.

Primary outcomes

  1. Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs

    Time frame: Up to 2 weeks post-operatively

    Evaluate postoperative pain level by documenting the number of pain pills taken during the initial two weeks of the healing process.

  2. Evaluate swelling and bleeding perception after autogenous gingival graft comparing 3 different palatal dressing designs

    Time frame: 2 weeks, 1 month and 3 months post-operative

    Using a Visual Analog scale (VAS) questionnaire indicating the subject's perception of swelling and bleeding following the graft. The VAS is a type of self-report tool where subjects mark a point on a continuous line to indicate the intensity of a subjective experience between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale. Essentially, it measures the degree of a symptom along a visual continuum.

  3. Evaluate the willingness to retreat by the subjects after autogenous gingival graft comparing 3 different palatal dressing designs

    Time frame: 2 weeks, 1 month and 3 months post-operative

    Using a Visual Analog scale (VAS) questionnaire indicating the subject's willingness to retreat following the graft. The VAS is a type of self-report tool where subjects mark a point on a continuous line to indicate the intensity of a subjective experience between two extreme anchor points (e.g., "no pain" at one end and "worst possible pain" at the other), allowing for a more nuanced response compared to a standard Likert scale. Essentially, it measures the degree of a symptom along a visual continuum.

Study contacts

Contact information is provided by the study sponsor or research team.

Anamika Khosla

CONTACT

[email protected]

8048284868

Rafael Amorim Cavalcanti de Siqueira

CONTACT

[email protected]

8046288377

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

Patient-reported Outcomes of Donor Site Healing Using Different Palatal Protection Techniques: a Randomized Controlled Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 24, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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