Palatal Protection Techniques for Gum Recession

Overseen By Rafael Amorim Cavalcanti de Siqueira

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Must not be taking: Anticoagulants

Disqualifiers: Diabetes, Immunosuppressive, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Immediate post-operative period

42 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulants (blood thinners), you may not be eligible to participate.

Is the use of fiber-reinforced composite resin techniques generally safe for humans?

The articles reviewed focus on the use of fiber-reinforced composite resin (FRC) in dental applications, such as temporary dentures and periodontal splints. While they do not specifically address safety, these techniques are commonly used in dentistry, suggesting they are generally considered safe when applied by skilled professionals. ^{1 2 3 4 5}

How does the 3-D printed acrylic resin stent (3DS) technique for gum recession differ from other treatments?

The 3-D printed acrylic resin stent (3DS) technique for gum recession is unique because it uses advanced 3-D printing technology to create a custom-fit stent, which can be more precise and comfortable compared to traditional methods. This approach may reduce the need for complex laboratory procedures, making the treatment process quicker and potentially more accessible for patients. ^{6 7 8 9 10}

What is the purpose of this 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.

Research Team

Rafael Amorim Cavalcanti de Siqueira

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

This trial is for adults at least 18 years old with healthy gums or mild gum disease who need a soft-tissue graft on 1 to 3 teeth or implants and have a thick enough palate. Participants must be willing to sign consent, not smoke, not be pregnant, and can't have conditions that affect healing like diabetes.

Inclusion Criteria

I need soft-tissue grafting for 1 to 3 teeth or implants.

Minimum palatal thickness of 2 mm

Willing to participate and sign an informed consent

Exclusion Criteria

Smokers

I have had tissue taken from the roof of my mouth for a graft.

Pregnant patients

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo autogenous soft-tissue graft surgery with different palatal protection techniques applied post-operatively

Immediate post-operative period

1 visit (in-person)

Initial Follow-up

Participants are monitored for postoperative pain, swelling, and bleeding perception using VAS questionnaires

2 weeks

1 visit (in-person)

Extended Follow-up

Participants' willingness to retreat and healing progress are evaluated at 1 month and 3 months post-operatively

3 months

2 visits (in-person)

Treatment Details

Interventions

• 3-D printed acrylic resin stent (3DS) technique
• Flowable resin composite stent (FRC) technique
• Vacuum-formed retainer (VFR) technique

Trial Overview The study tests three different techniques to protect the palate after a gum graft: using a vacuum-formed retainer (VFR), a custom-made 3-D printed stent (3DS), or applying flowable resin composite (FRC). It measures how well each method helps the donor site heal through questionnaires, measurements, and photographs.

Participant Groups

Group I: Vacuum-formed retainer (VFR): plastic device Experimental Treatment 4 Interventions

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.

Group II: Flowable resin composite stent (FRC) Experimental Treatment 4 Interventions

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.

Group III: 3-D printed acrylic resin stent (3DS): Experimental Treatment 4 Interventions

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.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Replacement of a maxillary central incisor using a polyethylene fiber-reinforced composite resin fixed partial denture: a clinical report. [2008]

2. United States pubmed.ncbi.nlm.nih.gov

Four-Year Clinical Evaluation of GFRC-RBFPDs as Periodontal Splints to Replace Lost Anterior Teeth. [2018]

3. Israel pubmed.ncbi.nlm.nih.gov

[Fiber-reinforced composite in fixed prosthodontics]. [2015]

4. United States pubmed.ncbi.nlm.nih.gov

3D-WOVEN FIBER-REINFORCED COMPOSITE FOR CAD/CAM DENTAL APPLICATION. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Alternative fabrication method for chairside fiber-reinforced composite resin provisional fixed partial dentures. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Soft palate obturator prosthesis made with visible light-cured resin. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Prosthetic rehabilitation of the cleft palate patient. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Long-term outcome analysis of two treatment methods for cleft palate: combined levator retropositioning and pharyngeal flap versus double-opposing Z-plasty. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Efficacy of a new membrane obturator prosthesis in terms of speech, swallowing, and the quality of life of patients with acquired soft palate defects: study protocol of the VELOMEMBRANE randomized crossover trial. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Provisional restoration for a patient with cleft lip and palate: a clinical report. [2019]