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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods to protect the roof of the mouth after gum graft surgery. It compares three techniques: a 3-D printed acrylic resin stent (3DS), a flowable resin composite stent (FRC), and a vacuum-formed retainer (VFR). The goal is to determine which method promotes better healing and more comfortable recovery. Suitable participants have healthy mouths but require soft-tissue grafts for 1 to 3 teeth or implants. As an unphased trial, this study provides a unique opportunity to contribute to innovative dental care solutions.

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.

What prior data suggests that these palatal protection techniques are safe for gum recession treatment?

In a previous study, vacuum-formed retainers (VFRs) showed a small but insignificant loss in the connection between teeth and gums, indicating they are generally safe for gum health. Another study found that VFRs led to less plaque and better gum health compared to other retainers.

Research on flowable resin composite stents (FRC) suggests they help reduce pain after gum surgeries by protecting the wound. Studies have shown these stents are well tolerated by patients and aid healing without major side effects.

For the 3-D printed acrylic resin stent (3DS), direct evidence on safety is limited. However, similar materials used in other dental treatments have proven to be safe and effective.

Overall, the available data suggests these methods are generally safe for protecting the roof of the mouth after a gum graft. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these palatal protection techniques for gum recession because they offer innovative ways to safeguard the healing area after surgery. The 3-D printed acrylic resin stent (3DS) is customized to fit a patient's mouth precisely, providing maximum comfort and minimizing the risk of a gag reflex. The flowable resin composite stent (FRC) acts as a protective barrier that can help reduce pain by shielding the wound from the oral environment. The vacuum-formed retainer (VFR) technique uses a thermoformed plastic device for mechanical retention, ensuring stability and comfort. These methods promise to enhance healing and patient comfort compared to traditional protective methods like surgical dressings or temporary splints.

What evidence suggests that these palatal protection techniques are effective for gum recession?

This trial will compare three techniques for palatal protection after gum graft surgery. Studies have shown that a flowable resin composite stent (FRC), one technique in this trial, can reduce pain and improve healing by creating a protective layer over the wound. Another technique, the vacuum-formed retainer (VFR), is known for keeping teeth in place after braces, though it might slightly affect the gums over time. The third technique, the 3-D printed acrylic resin stent (3DS), is designed for a precise fit, aiding in the protection and healing of gum areas. Each method offers unique benefits for protecting the palate and promoting healing after gum surgery. ^{1 2 3 4 6}

Who Is on the Research Team?

Rafael Amorim Cavalcanti de Siqueira

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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

Minimum palatal thickness of 2 mm

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10102060/

Accurate gingival recession quantification using 3D digital ... The suggested method offers highly accurate monitoring of gingival margin changes and diagnosis of gingival recessions using 3D digital dental models.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36424472/

Accurate gingival recession quantification using 3D digital ... The suggested method offers highly accurate monitoring of gingival margin changes and diagnosis of gingival recessions using 3D digital dental models.

3. researchgate.net researchgate.net/publication/365726372_Accurate_gingival_recession_quantification_using_3D_digital_dental_models

(PDF) Accurate gingival recession quantification using 3D ... Conclusions The suggested method offers highly accurate monitoring of gingival margin changes and diagnosis of gingival recessions using 3D ...

4. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-021-01541-z

Propylene mesh versus acrylic resin stent for palatal wound ... Table 3 Results of clinical outcomes ... Treatment of multiple areas of gingival recession using a simple harvesting technique for autogenous ...

5. researchgate.net researchgate.net/publication/381262780_3D-printed_resin_composite_posterior_fixed_dental_prosthesis_a_prospective_clinical_trial_up_to_1_year

3D-printed resin composite posterior fixed dental prosthesis Objectives: This clinical trial evaluated the clinical behavior of 3D-printed posterior resin composite fixed dental prostheses (FDPs).

6. malacards.org malacards.org/card/gingival_recession

Gingival Recession Gingival recession, also known as gum recession, is the exposure of tooth roots due to loss of gum tissue or retraction of the gingival margin.