Lateral Ridge Augmentation Using Cross-linked or Non-cross-linked Collagen Membrane: a Pilot Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Linear measurements outcomes
研究概览
简要总结
The objective of the present trial is to test clinically, radiographically and histologically , in a lateral alveolar ridge augmentation model (without simultaneous implant placement) the efficiency in supporting bone formation of a glutaraldehyde cross-linked collagen membrane compared to a non-cross-linked collagen membrane with the use of a composite autograft-xenograft mix prepared in a 1:3 ratio
详细描述
This study is a pilot one, no sample size calculation has been performed. Random allocation was done by the sequentially sealed envelope method.
Interventions
Pre-operative preparation:
- Scaling and root planning and delivering proper hygiene instructions.
- Fabrication of the occlusal stent/radiographic guide (Silicone impression of the concerned arch and pouring of the model. Denture teeth are added on the edentulous space of the cast. A 2 mm thickness clear resin sheet is adapted to the cast with a vacuum forming machine. The borders of the stent are trimmed with a tungsten carbide bur to remove the parts that are covering the soft tissues. At the level of the surgical site, the intaglio of the guide is reduced in a way to prevent any interference with the swollen soft tissues during the one-week CBCT assessment. In the middle of each denture tooth, 2 mm cylindrical holes are created occlusally. Gutta-percha is inserted in these holes to serve as radio-opaque markers and as reference points for per-operative measurements.
- Pre-operative Cone Beam CT (CBCTpreop) with the radiographic guide/occlusal stent in the mouth
Surgical intervention:
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 patients are blind to the allocation. The radiographic volumetric changes and the histomorphometrical analysis are assessed by blind examiners.
Random allocation was done by the sequentially sealed envelope method. At the time of membrane placement during the surgery, the envelope corresponding to the case sequence number is opened specifying the group allocation.
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy patients, non-smokers or smokers<10 cigarettes/day.
- •Age between 20 and
- •Full mouth bleeding score (FmBS) <20 %.
- •Full mouth plaque score (FmPS) <15%.
- •Presence of a residual alveolar ridge with residual bone width < 5 mm and adequate
- •bone height in the maxilla and the mandible.
- •Tooth extraction performed at least 6 weeks before surgery.
- •Presence of enough teeth to support an occlusal stent/radiographic guide.
排除标准
- •Systematic diseases.
- •History of radiotherapy in the head and neck region in the last 5 years.
- •Active periodontitis on the remaining teeth.
- •Pregnancy.
- •Allergy to collagen.
- •Intake of medications that may have an effect on bone turnover and mucosal healing (i.e., tetracycline within the last month, steroids within the last 6 months, bisphosphonates or fluorides at bone therapeutic levels, vitamin D and metabolites at therapeutic levels within the last 6 months).
结局指标
主要结局
Linear measurements outcomes
时间窗: 6 - 9 months
the ridge mapping changes in linear measurements between initial ridge width and reentry ridge width at 1, 3 and 5 mm from the ridge crest
次要结局
- Volumetric measurements outcome(6 - 9 months)
- the percentage of graft volume resorption.(6 - 9 months)
- Linear measurements outcomes on DICOM data(6 - 9 months)
- Soft tissue healing(6 - 9 months)
- Periodontal Probe Penetration (PP)(6 - 9 months)
- Histology(6 - 9 months)
- Histomorphometry: percentage of new bone formation(6 - 9 months)
- Histomorphometry: percentage of remaining graft particles(6 - 9 months)
- Histomorphometry: percentage of connective tissue(6 - 9 months)
研究者
Mario Haddad
Principal Investigator
Saint-Joseph University