跳至主要内容
临床试验/NCT06593275
NCT06593275尚未招募不适用

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

Universidad de Especialidades Espiritu Santo2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
2
主要终点
Postoperative pain perception in the palate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Postoperative pain perception in the palate

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Universidad de Especialidades Espiritu Santo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Lanata Flores

Assistant Professor

Universidad de Especialidades Espiritu Santo

研究点 (2)

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