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

NCT06593275 | Not Yet Recruiting

• 1 other identifier: 2024-ODONT-002B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Perception of Pain; Protection of the Palate

Keywords

protection of the palate; pain palate; flow resine; self-adhesive dressing

Outcome Measures

Primary Outcomes (1)

• Postoperative pain perception in the palate

  The harvesting of a connective tissue graft from the palate is the gold standard for periodontal and peri-implant surgery, in which the patient reports greater discomfort in this area if it is not properly protected. From this point of view, randomized patients who will receive protection with fluid resin or self-adhesive dressing will be required to fill out a visual analog scale form in which 0 is the minimum pain presented and 10 the maximum pain. The results will be tabulated to make a comparison between both techniques and to verify which one presented the least postoperative pain.

  Participants will fill out forms from day 1 after surgery until day 14

Study Arms (2)

Control group

EXPERIMENTAL

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.

Procedure: Protection of the palatal donor area with flowable resin

Experimental group

EXPERIMENTAL

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.

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

Interventions

Protection of the palatal donor area with flowable resin PROCEDURE

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

Control group

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

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

Universidad de Especialidades Espiritu Santo

Samborondón, Guayas, 09-01-952, Ecuador

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 30, 2024
• Primary Completion: December 15, 2024
• Study Completion (Estimated): December 15, 2029
• Last Updated: October 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)