Soft Tissue Volume Augmentation of Localized Horizontal Ridge Defects Using Autologous Fat Grafting Versus Subepithelial Connective Tissue Graft (a Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Volumetric analysis to evaluate soft tissue volume changes
研究概览
简要总结
The aim of this study was to evaluate the effectiveness of autologous fat as a grafting material for soft tissue volume augmentation of localized horizontal ridge defects in humans.
详细描述
A total of 20 patients having 26 localized horizontal ridge defects were recruited for the study from the patient pool at the dental clinics of the faculty of dentistry, Alexandria University. Ridge defects were divided into two parallel groups:
Test group: localized ridge defects were augmented using autologous fat grafting Control group: localized ridge defects were augmented using conventional subepithelial connective tissue graft.
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 (Outcomes Assessor)
盲法说明
Neither the operator nor the participants could be blinded to the treatment type as the intervention procedures were markedly different between test and control groups. To enable blinding during outcome assessment, the stereolithography (STL) files of digitized casts were given a code different from that of the allocation procedure and were kept confidential. The volumetric analysis was performed and the groupings were shared with the biostatistician as groups A and B. Only during the interpretation the codes and groups were translated into test and control groups
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients had at least one localized horizontal ridge defect in a single tooth gap requiring soft tissue volume augmentation.
- •Teeth in the defect area have been extracted at least 3 months prior to enrolment
- •All patients were systemically healthy
- •Patients were non-smokers
- •Patients had abdominal fat accumulation allowing liposuction
- •Ability to understand the nature of the proposed surgery and ability to sign an informed consent form
排除标准
- •General contra-indications to surgical procedures
- •Systemic diseases like Diabetes Mellitus and autoimmune diseases
- •History of malignancy, chemotherapy or radiotherapy within the last 5 years
- •Concurrent medication affecting mucosal healing in general (e.g. steroids, large doses of anti-inflammatory drugs)
结局指标
主要结局
Volumetric analysis to evaluate soft tissue volume changes
时间窗: 3 months
To evaluate the volumetric changes of soft tissues, all the stone models will be digitized using a lab-based optical scanner. The digital surface models will be imported as STL files into the image analysis software for volumetric analysis. Digital cast models representing the different time points during the follow up will be superimposed using tooth surfaces as references. The relevant area for the measurements of volume changes will be defined and volume changes will be calculated by the same examiner according to previous studies
次要结局
- Width of Keratinized tissue(3 months)
- Probing depth(3 months)
- Clinical attachment loss (CAL)(3 months)
- Bleeding on probing(3 months)
研究者
Nourhan M.Aly
Instructor of Dental Public Health
University of Alexandria