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

October 7, 2024 updated by: Antonio Lanata Flores, Universidad de Especialidades Espiritu Santo
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Samborondon, Guayas, Ecuador, 09-01-952
        • Universidad de Especialidades Espiritu Santo
        • Contact:
        • Contact:
          • Christian G Garcia, 3 level

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Procedure: 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
Experimental: 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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain perception in the palate
Time Frame: Participants will fill out forms from day 1 after surgery until day 14
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Especialidades Espiritu Santo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 30, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2029

Study Registration Dates

First Submitted

September 9, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 10, 2024

Last Update Submitted That Met QC Criteria

October 7, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-ODONT-002B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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