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临床试验/NCT05688293
NCT05688293招募中不适用

Gingival Recession (RT1) Treatment With Different Gingival Augmentation Surgeries Compared With Untreated Contralateral Sites: A Randomized Controlled Clinical Study

Misr International University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年2月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Gingival phenotype change

研究概览

简要总结

Thin gingival phenotype is one of the major causative factors of gingival recession type 1 which can result in hypersensitivity, discomfort, and compromised esthetics. This study assess the efficacy of increasing the gingival thickness from thin gingival phenotype to thick gingival phenotype in the treatment of patients suffering from gingival recession (RT1) and maintenance of results using either connective tissue graft or de-epithelized free gingival graft after non-surgical periodontal debridement compared to non-surgical periodontal debridement alone.

详细描述

This parallel arm randomized controlled clinical trial study will include systematically free patients with thin gingival phenotype. They will be randomly allocated to three equal groups. Group A (test group, n=10) will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique, Group B (test group, n=10) will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft, while group C (control group, n=10) will receive non-surgical periodontal treatment only. After 3, 6 and 12 months gingival biotype will be clinically assessed (1ry outcome). This parameter will be recorded at baseline, 3, 6 and 12 months. The 2ry outcomes will include recording of recession depth, plaque index, bleeding on probing, keratinized tissue width . Postoperative pain and swelling will be recorded daily by the patient for the 1st two weeks post-surgically. Postoperative instructions and medication will be given to the patient. All readings will be carried out by a calibrated outcome assessor who will be masked. Follow-up will be performed to assess the outcomes and to ensure performing proper oral hygiene. Data collected will be tabulated and statistically analyzed.

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
Double (Participant, Outcomes Assessor)

盲法说明

the patient won't know the type of the procedures done to him The outcome assessor won't know which group he the is assessing it's results

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Medically free patients (American Society of Anesthesiologists I; ASA I)
  • Patients diagnosed with recession (RT1)
  • Fair oral hygiene
  • Patient accepting to provides an informed consent and the follow-up

排除标准

  • Carious teeth and teeth with periapical infection.
  • Patients diagnosed with periodontitis
  • Pregnant and lactating females

研究组 & 干预措施

Free gingival Graft

Active Comparator

Patients will receive non-surgical periodontal treatment and partially de-epithelized free gingival graft

干预措施: Free gingival graft (Procedure)

Connective tissue graft

Active Comparator

Patients will receive non-surgical periodontal treatment and connective tissue graft using tunneling technique

干预措施: Connective tissue graft (Procedure)

Non surgical procedure

Active Comparator

Patients will receive non-surgical periodontal treatment only

干预措施: Non surgical (Procedure)

结局指标

主要结局

Gingival phenotype change

时间窗: at baseline 3,6 and 12 months

determination of the change in gingival thickness in mm using periodontal probe

次要结局

  • Keratinized tissue width(at baseline 3,6 and 12 months)
  • Root coverage esthetic score (RES)(at baseline 3,6 and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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