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Mucosal ErosionNCT06892496

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

A study testing Visual Analog scale (VAS) questionnaire, Vacuum-formed retainer (VFR) technique and 3-D printed acrylic resin stent (3DS) technique in people with Mucosal Erosion and Gingival Recession, run by Virginia Commonwealth University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mucosal Erosion, Gingival Recession
What is being tested?
Visual Analog scale (VAS) questionnaire, Vacuum-formed retainer (VFR) technique and 3-D printed acrylic resin stent (3DS) technique
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
7 Mar 2025to Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rafael Amorim Cavalcanti de Siqueira contact

8046288377

amorimcavalr@vcu.edu

Anamika Khosla contact

8048284868

khoslaar@vcu.edu

United States1 site, 1 recruiting
  • Virginia Commonwealth University

    Richmond, Virginia, 232398

    Rafael Amorim Cavalcanti de Siqueira, 804-628-8377, amorimcavalr@vcu.edu

    Anamika Khosla, 8048284868, khoslaar@vcu.edu

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

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.

Being tested
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
Keywords
soft tissue graft, pain, wound healing, CPS: Chairside polymer stent
Medical subject headings
Gingival Recession, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Visual Analog scale (VAS) questionnaireOther

    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) techniqueOther

    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) techniqueOther

    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) techniqueOther

    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 palateOther

    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 dimensionsOther

    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 StentOther

    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.

Study groups in NCT06892496
Study groupRoleWhat they receive
Vacuum-formed retainer (VFR): plastic deviceExperimentalSubjects 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.
Receives: Other: Visual Analog scale (VAS) questionnaire; Other: Vacuum-formed retainer (VFR) technique; Other: Photographs of the patient's palate; Other: Measuring graft dimensions
3-D printed acrylic resin stent (3DS): digitally designedExperimentalSubjects 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.
Receives: Other: Visual Analog scale (VAS) questionnaire; Other: 3-D printed acrylic resin stent (3DS) technique; Other: Photographs of the patient's palate; Other: Measuring graft dimensions
Flowable resin composite stent (FRC): mechanical barrierExperimentalAfter 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.
Receives: Other: Visual Analog scale (VAS) questionnaire; Other: Flowable resin composite stent (FRC) technique; Other: Photographs of the patient's palate; Other: Measuring graft dimensions
Chairside Polymer Stent:CPS: mechanical barrierExperimentalDuring 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.
Receives: Other: Visual Analog scale (VAS) questionnaire; Other: Photographs of the patient's palate; Other: Measuring graft dimensions; Other: Chairside Polymer Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: Up to 2 weeks post-operatively

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

    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.

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

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start7 Mar 2025
  3. Primary completionJan 2027 (estimated)
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study team will assign randomly which palatal post-operative protection technique the patient will undergo by utilizing a dedicated software (Research Randomizer). The study team will then initiate the fabrication of the palatal stent in cases where VFR or 3DS groups are assigned to the patient.
Masking
None (open label)
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06892496
Sponsor's protocol ID
HM20028832
Status last verified
Aug 2026
First submitted
7 Mar 2025
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Visual Analog scale (VAS) questionnaire, Vacuum-formed retainer (VFR) technique and 3-D printed acrylic resin stent (3DS) technique in people with Mucosal Erosion and Gingival Recession, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rafael Amorim Cavalcanti de Siqueira (8046288377, amorimcavalr@vcu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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