Pain Perception in Protection of the Palatal Donor Area After Harvesting a Free Gingival Graft Using Flowable Resin Versus a Self-adhesive Dressing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-30

Study Completion Date

2029-12-15

Brief Summary

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The use of a connective tissue graft harvested from the palate is currently one of the most effective and predictable alternatives for the correction of periodontal and peri-implant defects, but the discomfort generated in the palate is sometimes greater than mucogingival surgery. For this reason, we found the need to use different materials for palatal protection. In one group we will use light-cured fluid resin compared to another group a self-adhesive dressing to check which of these materials provides less postoperative pain generated by the harvest of a free gingival graft.

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Detailed Description

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The postoperative pain generated by the harvest of a free gingival graft for the correction of periodontal or peri-implant defects, it\'s greater when it is not adequately protected and until the reepithelialization of the area is complete. For this reason, it was decided to use two materials to compare the effectiveness in reducing postoperative pain in grafts larger than 15 mm. A control group will be treated with a hemostatic collagen sponge and photocured fluid resin, adhered to the palatal surfaces of the neighboring teeth using an adhesive protocol and X-shaped sutures. Another experimental group will be treated with a hemostatic sponge and placement of a self-adhesive dressing stabilized by X-shaped sutures to ensure its permanence in the mouth. The participants will fill out a daily visual analog scale form for 14 days until the removal of the materials. Finally, the results will be tabulated and compared to provide a conclusion of our study.

Conditions

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Perception of Pain Protection of the Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study includes 30 patients who will undergo periodontal or peri-implant surgery with collection of a connective tissue graft from the palate to assess the perceived postoperative pain according to both palatal protection techniques in reference to L. Tavelli et al. 2017. They will be divided into 2 randomized groups, 15 with photocured fluid resin protection and the remaining 15 with a self-adhesive and sutured dressing.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patient will not know what protection technique will be used during surgery, but the operator will know at the time prior to surgery with a randomization

Study Groups

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Control group

This group is defined by the use of a collagen hemostatic sponge and photocured fluid resin for the protection of the palatal donor area by means of an adhesive protocol to the palatal surfaces of the neighboring teeth and fixed with X-suture to improve its stability in the area. A visual analog scale examination will be performed to assess the postoperative pain generated in the palate from day 1 to 14 and ending with the removal of this protection.

Group Type EXPERIMENTAL

Protection of the palatal donor area with flowable resin

Intervention Type PROCEDURE

Use of fluid resin for protection of the palatal donor area to assess postoperative pain generated during14 days

Experimental group

This group is defined by the use of a collagen hemostatic sponge and a self-adhesive dressing for the protection of the palatal donor area and fixed with an X-shaped suture to improve its stability in the area. A visual analog scale examination will be performed to evaluate the postoperative pain generated in the palate from day 1 to 14 and ending with the removal of this protection.

Group Type EXPERIMENTAL

Protection of the palatal donor area with a self-adhesive dressing

Intervention Type PROCEDURE

Use of a self-adhesive dressing for protection of the palatal donor area to evaluate postoperative pain generated for 14 days

Interventions

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Protection of the palatal donor area with flowable resin

Use of fluid resin for protection of the palatal donor area to assess postoperative pain generated during14 days

Intervention Type PROCEDURE

Protection of the palatal donor area with a self-adhesive dressing

Use of a self-adhesive dressing for protection of the palatal donor area to evaluate postoperative pain generated for 14 days

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients over 18 years of age
* Patients with plaque control less than 20%
* Patients with bleeding on probing less than 10%
* Patients in need of periodontal or peri-implant surgery in the upper or lower jaw
* Not having previous surgeries in the donor area

Exclusion Criteria

* Pregnant or breastfeeding patients
* Patients with lesions in the palate
* Patients who use prostheses that cover the palate
* Patients with active periodontal disease
* Patients who smoke
* Patients with systemic diseases
* Torus palatinus
* Patients with a history of chemotherapy and radiotherapy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes