Clinical trial NCT06593275: Pain Perception in Protection of the Palatal Donor Area After Harvesting a Free Gingival Graft Using Flowable Resin Versus a Self-adhesive Dressing
Official title: Pain Perception in Protection of the Palatal Donor Area After Harvesting a Free Gingival Graft Using Flowable Resin Versus a Self-adhesive Dressing
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Perception of Pain
Protection of the Palate
Keywords: protection of the palate
pain palate
flow resine
self-adhesive dressing
Lead sponsor: Universidad de Especialidades Espiritu Santo
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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\&#39;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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain perception in the palate
timeFrame: Participants will fill out forms from day 1 after surgery until day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Samborondon
country: Ecuador
facility: Universidad de Especialidades Espiritu Santo
state: Guayas
Study officials:
References: