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

Virginia Commonwealth University (VCU)

Status: Enrolling

Conditions: Gingival Recession; Mucosal Erosion

Treatments: Other: Visual Analog scale (VAS) questionnaire; Other: Flowable resin composite stent (FRC) technique; Other: Vacuum-formed retainer (VFR) technique; Other: Photographs of the patient's palate; Other: 3-D printed acrylic resin stent (3DS) technique; Other: Measuring graft dimensions

Study type: Interventional

Funder types: Other

Identifiers

NCT06892496

HM20028832

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 3 patient groups

Vacuum-formed retainer (VFR): plastic device

Experimental group

Description:

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.

Treatment:

Other: Measuring graft dimensions

Other: Photographs of the patient's palate

Other: Vacuum-formed retainer (VFR) technique

Other: Visual Analog scale (VAS) questionnaire

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

Experimental group

Description:

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.

Treatment:

Other: Measuring graft dimensions

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

Other: Photographs of the patient's palate

Other: Visual Analog scale (VAS) questionnaire

Flowable resin composite stent (FRC)

Experimental group

Description:

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.

Treatment:

Other: Measuring graft dimensions

Other: Photographs of the patient's palate

Other: Flowable resin composite stent (FRC) technique

Other: Visual Analog scale (VAS) questionnaire