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临床试验/NCT06228534
NCT06228534已完成早期 1 期

Root Coverage With Tunneling Technique With Connective Tissue Versus Coronal Advancement Flap Technique. A 3- and 6-month Follow-up of a Randomized Clinical Trial.

Luis Alberto Chauca Bajaña2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年1月15日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
20
试验地点
2
主要终点
coronal advancement flap technique

研究概览

简要总结

This is a randomized triple-blind clinical trial. This comparative clinical study investigates the efficacy of root coverage using two periodontal techniques: the tunneling technique and the coronal advancement technique. The objective is to evaluate and compare the clinical, esthetic and patient perception outcomes after undergoing each procedure. Participants with specific gingival recessions will be included, and follow-up will be performed to measure root coverage, keratinized tissue gain and other relevant parameters. In addition, a detailed analysis of the morbidity associated with each technique will be performed. This study aims to provide valuable information to guide oral health professionals in choosing the most appropriate technique for the treatment of gingival recessions.

详细描述

Donor area Surgeries were initiated in all participants by removing connective tissue from the mucosa of the palate using the deepithelialized free gingival graft technique.

Receiving area

  • TUN + CTG (test group)

Zabalegui et al. detailed the surgical procedure as follows:

The tunnel is created by making a partial-thickness incision in each recession area that will be addressed in the procedure. Special attention is paid to the manipulation of the tissue beyond the mucogingival junction, in order to obtain a tunnel without tension that facilitates the insertion of the graft.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Non-smoking
  • No systemic diseases, no pregnancy
  • No active periodontal disease
  • Bacterial plaque and bleeding Score ≤9%.
  • No medication that interferes with periodontal tissue health or scarring.
  • Teeth without root canal treatments
  • No contraindication to periodontal surgery
  • Presence of at least one type I and II Miller O RT1 - RT2 recession defect with at least 4 recessions in the upper or lower jaw that clearly shows the amelocementary limit.
  • Work will be done on upper central incisors, upper lateral incisors, upper canines and upper premolars.
  • For the coronal advancement technique, multiple or unitary gingival recessions will be used

排除标准

  • SMOKING PATIENT
  • PATIENT WITH A SYSTEMIC DISEASE
  • WITH PERIODONTAL DISEASE
  • GINGIVAL RECESSION CLASS III OR RT3
  • PATIENT WITH EDENTULISM
  • PATIENT WITHOUT AMELOCEMENTARY LIMIT

结局指标

主要结局

coronal advancement flap technique

时间窗: A 6 month follow-up

Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)

tunneling technique

时间窗: A 6 month follow-up

Periodontal status and smoking habits (% of bleeding and bacterial plaque) Type ode recesión (I o II) Recession location (upper and lower jaw) Preoperative preparation Treatment in the intervention group Post-surgical treatment Suture time mRC ± SD (%) (recubrimiento radicular) Aesthetic Root Cover Score (RES) percentage of root coverage (RC, %) and percentage of defects with complete root coverage (CRC, %)

次要结局

  • tunneling technique(A 3 - 6 month follow-up)
  • coronal advancement flap technique(A 3 - 6 month follow-up)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Luis Alberto Chauca Bajaña

specialist in periodontics and surgical implantology, master in research, PHD (C)

Universidad de Guayaquil

研究点 (2)

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