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NCT Number: NCT06593275

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Especialidades Espiritu Santo

Samborondón, Guayas, 09-01-952, Ecuador

Location contact

Antonio G Lanata, 5 level

CONTACT

[email protected]

+593983820084

Christian G Garcia, 3 level

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Especialidades Espiritu Santo

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2029
First posted
Sep 19, 2024
Registry last updated
Oct 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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