Recruiting

Palatal Protection

Sponsor:

Virginia Commonwealth University

Code:

NCT06892496

Conditions

Mucosal Erosion

Gingival Recession

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visual Analog scale (VAS) questionnaire

Vacuum-formed retainer (VFR) technique

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

Flowable resin composite stent (FRC) technique

Photographs of the patient's palate

Study Details

Brief summary:

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.

Conditions

Mucosal Erosion

Gingival Recession

Study ID

NCT06892496

Start date

Mar 7, 2025

Status verified date

Aug, 2026

Completion date

Jan, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

56 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vacuum-formed retainer (VFR): plastic device

Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model of the jaw.. A resin model will be 3D printed generating the physical model. A palatal stent will be made out of thermoforming plastic in the model using a vacuum, The stent will cover the palate and the anterior and posterior teeth, including their occlusal and buccal surfaces bilaterally, to provide retention. On the day of the surgery, at the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. The previously made plastic palatal stent (VFR) will be placed in position and stabilized by mechanical retention using the palate and maxillary teeth, bilaterally. The subjects will be instructed to wear the stent uninterruptedly in the first 3 days and per their preference on the 4th day and after.

experimental: 3-D printed acrylic resin stent (3DS): digitally designed

Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model file of the patient's jaws. A palatal stent will be digitally designed. The stent will cover the palatal area to the maximum extent, respecting the limit between the hard and soft palate to avoid any discomfort or gag reflex by the subjects. At the final stage of the surgical procedure (after the graft placement and suture of the recipient site), a collagen sponge will be positioned in the palatal wound, and non-resorbable sutures will be placed above the sponge. 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.

experimental: Flowable resin composite stent (FRC): mechanical barrier

After the placement of the graft and the suture of the recipient site, a collagen sponge will be positioned in the palatal wound. Then, a layer of cyanoacrylate (PeriAcryl 90HV, GluStitch) will be placed above the sponge using a microbrush. Non-resorbable sutures will be placed covering the palatal dressing, with the suture knots facing the buccal surfaces of the maxillary posterior teeth. Finally, 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. Subjects will have both dental arches scanned using an intraoral optical scanner to generate the digital model for secondary analysis.

experimental: Chairside Polymer Stent:CPS: mechanical barrier

During the preoperative appoint, both dental arches scanned using an intraoral optical scanner scanner (TRIOS, 3Shape) to generate the digital model in .STL file of the patient's jaws. In this group, the .STL files of the digital models of patient's jaws are not necessary for the fabrication of the stent but will be stored for future analysis of secondary outcomes of the research that includes the healing of the palatal wound via volumetric and linear changes analysis. Before the graft has been harvested, 4 cubes of Zn-containing granules are placed into a warm water bath and manipulated into a 2mm disk and placed in the patient's mouth to be formed to fit the patient. After the graft has been harvested, 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.

Interventions

Visual Analog scale (VAS) questionnaire

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

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

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

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

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

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

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 outcome measure

  • Evaluate postoperative pain level after autogenous gingival graft comparing 3 different palatal dressing designs [ Time Frame: Up to 2 weeks post-operatively ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Rafael Amorim Cavalcanti de Siqueira

8046288377amorimcavalr@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 232398

Contacts

Rafael Amorim Cavalcanti de Siqueira

804-628-8377amorimcavalr@vcu.edu

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • soft tissue graft
  • pain
  • wound healing
  • CPS: Chairside polymer stent

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-08-05.