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

U

Universidad de Especialidades Espiritu Santo

Status

Not yet enrolling

Conditions

Perception of Pain
Protection of the Palate

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06593275
2024-ODONT-002B

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Control group
Experimental group
Description:
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.
Treatment:
Procedure: Protection of the palatal donor area with flowable resin
Experimental group
Experimental group
Description:
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.
Treatment:
Procedure: Protection of the palatal donor area with a self-adhesive dressing

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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