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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06593275
Enrollment
30
Registered
2024-09-19
Start date
2024-10-30
Completion date
2029-12-15
Last updated
2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perception of Pain, Protection of the Palate

Keywords

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

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.

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.

Interventions

PROCEDUREProtection 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

PROCEDUREProtection 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

Sponsors

Universidad de Especialidades Espiritu Santo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

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

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain perception in the palateParticipants will fill out forms from day 1 after surgery until day 14The 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.

Countries

Ecuador

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026