Comparison of d-PTFE Membrane With Titanium-mesh in Vertical Ridge Augmentation: A Split Mouth, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Changes in Vertical Bone Height
研究概览
简要总结
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.
详细描述
E) Study Procedures Visit 1: Screening (Approximately 30 mins) Informed consent will be obtained by the principal investigator or a co-investigator. The subjects will be instructed to read the informed consent form (ICF), given ample time to have any questions answered, and then instructed to sign the ICF. Subject will be given a copy of the ICF.
Subject will be asked to complete demographic information and a medical history.
Inclusion/exclusion criteria will be evaluated.
The pre-operative height of the bony crest will be evaluated on the pre-existing radiographs from the referring clinic if they are less than 6 months old. If recent radiographs do not exist, radiographs will be taken at this visit. It is standard of care to have radiographs from within the past 6 months prior to surgery.
Visit 2: Surgery (Approximately 180 mins) Medical history will be reviewed as standard of care. Eligibility and subject withdrawal criteria will be reviewed to ensure the subject still qualifies for the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age or older
- •Non-smokers
- •Existence of bilateral vertical/horizontal ridge deformities (Seibert Class III)
- •The length of the edentulous span is from two or more teeth
排除标准
- •The patients will not be admitted in the study if any of the following exclusion criteria are met:
- •Patients who have an infectious disease (self reported - HIV, tuberculosis or hepatitis)
- •Known allergies to the research-related materials
- •Patients who have compromised healing potential:
- •bone metabolic disease e.g., Paget's disease, osteoporosis, osteomalacia
- •uncontrolled diabetes: HbA1c >=7, values measured within six months (using the existing record in AxiUm or if the subject has the condition, but there is no report in AxiUm - a blood test record will be requested)
- •patient currently taking steroid medication
- •history of oral bisphosphonate intake greater than 3 years or any IV administration
- •Pregnant or lactating patients (self-reported), as part of TUSDM standard of care not to treat for non-emergency surgical procedures
- •Presence of surgical scar tissue from previous surgical procedure in the posterior mandible
- •Pathology present within the alveolar ridges in the posterior mandible, determined clinically or radiographically
- •History of radiation therapy to the mandible
- •Elective periodontal procedures are postponed during pregnancy, active infectious disease, bisphosphonate intake or uncontrolled diabetes as standard of care in the TUSDM department of periodontology. Diseases or conditions which have been shown to affect healing are excluded for research. Vertical ridge augmentation is not contraindicated with pregnancy and there is no known safely issues associated with it.
研究组 & 干预措施
All Study Participants - d-PTFE
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane.
干预措施: d-PTFE (Biological)
All Study Participants - Ti-mesh
The proposed study design is a randomized controlled trial, split mouth design, to compare the two different vertical augmentation procedures: Titanium mesh (Ti-mesh) technique and Guided Bone Regeneration (GBR) technique with a high-density polytetrafluoroethylene (d-PTFE) membrane
干预措施: Ti-mesh (Biological)
结局指标
主要结局
Changes in Vertical Bone Height
时间窗: from 6 months to 8 months following the procedure
intrasurgical clinical measurement in millimeter
次要结局
- Rate of Post-Operative Complications(Up to 6 months to 8 months following the procedure)
- Bone Core Histology(from 6 months to 8 months following the procedure)
研究者
Yumi Ogata
Associate Professor, Periodontology
Tufts University School of Dental Medicine