跳至主要内容
临床试验/NCT06435780
NCT06435780
招募中
不适用

Evaluation of a Novel Technique Versus Conventional Subepithelial Connective Tissue Graft in Treatment of Ridge Contour Defects. A Randomized Controlled Clinical Trial

Misr International University1 个研究点 分布在 1 个国家目标入组 50 人2023年4月1日
干预措施DIPRF

概览

阶段
不适用
干预措施
DIPRF
疾病 / 适应症
Defect in Alveolar Ridge
发起方
Misr International University
入组人数
50
试验地点
1
主要终点
Ridge contour thickness gain
状态
招募中
最后更新
3个月前

概览

简要总结

The aim of the study is to clinically and radiographically evaluate and compare two techniques to augment soft tissues: the conventional subepithelial connective tissue graft technique and a novel denuded interpositional pedicled rolled flap technique (DIPRF) These techniques will be used to augment edentulous ridges that are recommended for rehabilitation by an implant or a fixed restoration.

详细描述

Fifty patients with soft tissue ridge contour defects in the maxillary premolar region and recommended for rehabilitation by an implant or a fixed restoration will be enrolled. Patients will be allocated randomly into two groups; group 1 (test group) will have augmentation for their soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF); group 2 (control group) will be augmented by the conventional subepithelial connective tissue graft technique. Clinical volumetric change evaluation and ridge thickness analysis using digitally calibrated casts and CBCT analysis with a fusion software will be performed for every site as well as periodontal evaluation and patient centered outcomes, including pain and satisfaction after the procedure will be recorded for both techniques. For each site, an impression will be used to pour a cast that will be digitally scanned and vertical and horizontal ridge contours dimensions(tissue volumetric changes) will be recorded. These measurements will be obtained before the surgical procedure, 2 weeks, and 3 and 6 months post-surgical. CBCT analysis will be performed pre-operatively to confirm the diagnosis and eligibility of the case as having only soft tissue defect without bone defects, and 6 months postoperatively to analyze the amount of soft tissue gain in the two groups.

注册库
clinicaltrials.gov
开始日期
2023年4月1日
结束日期
2026年12月31日
最后更新
3个月前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Ahmed Abo El Futtouh

Clinical Director of International Implantology Program (IIP)

Misr International University

入排标准

入选标准

  • Adults above the age of 18 to 50 years.
  • Males and females as confirmed by asking the female patients about whether they are pregnant or not
  • Patient's with Seibert classification class I requiring future rehabilitation of one or more premolar region and sound adjacent teeth.
  • Soft tissue thickness on the palatal tissues more than 6mm at the site of harvesting the graft.
  • Presence of Mandibular posterior teeth opposing the tooth to be replaced for occlusion.
  • Clinically healthy soft tissues with no signs of clinical pathology of the soft tissue.
  • Good oral hygiene.
  • Patient accepts to sign an informed consent.
  • ASA I or ASA II Patient.

排除标准

  • Patients with ridge defects due to bone defect
  • Smoker patients who smoke more than 10 cigarettes per day
  • Pregnant females

研究组 & 干预措施

Experimental group

Augmentation of soft tissue by a novel Denuded interpositional pedicled rolled flap technique (DIPRF)

干预措施: DIPRF

Control group

Will be augmented by the conventional subepithelial connective tissue graft technique.

干预措施: DIPRF

结局指标

主要结局

Ridge contour thickness gain

时间窗: 6 months

Ridge contour will be assessed using CBCT analysis using fusion software. The differences between measurement times will indicate the amount of bone gain

研究点 (1)

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