The Efficacy of Low-Level Diode Laser Therapy on the Acceleration of Osseointegration and Mucosal Phenotype Around Delayed Dental Implant: 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
- 1
- 主要终点
- Change in marginal bone loss
研究概览
简要总结
Good quality soft tissue determines the possibility not only to obtain full primary wound closure during the bone defect reconstruction, but also assures effective implant treatment and stability of peri-implant condition.Moreover, it is very important to assure the proper emergence profile of the implant supported restorations, which give the opportunity to achieve the highest aesthetic appearance. In the long-term, the correct width and thickness of the attached keratinized tissue is the key point to ensure the stable position of the mucosal line around the implant's neck. The promising outcomes of laser on soft and hard tissue have been demonstrating in a variety of studies. Therefore, the aim of this clinical study is to evaluate the efficacy of LLDLT on enhancing osseointegration and on the peri-implant mucosal tissue around delayed dental implants.
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
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are systemically medically free.
- •Ability to maintain good oral hygiene as evidenced in recall visits.
- •Sufficient mesiodistal and interocclusal space and have an intact buccal bone contours which does not require bone augmentation procedures.
- •Adequate bone quality.
- •Keratinized tissue ≥ 2mm.
- •Thickness of the gingiva ≥ 1 mm.
排除标准
- •Presence of any systemic disease that could influence the outcome of the therapy.
- •Presence of any risk factor e.g.; smoker, pregnant, lactating patients or any disease affect bone healing.
- •Previous history of periodontal surgical treatment in quadrant selected for the study.
- •Restorations or caries in the area to be treated and non-vital tooth.
- •Adjacent teeth are tilted or rotated.
- •Patients taking medications known to cause affect bone quality.
- •Traumatic occlusion or Para-functional habits such as clenching or bruxism.
- •Participation in other clinical trials.
研究组 & 干预措施
Without laser
干预措施: Dental implant (Other)
With laser
干预措施: Dental implant + LLDL (Other)
结局指标
主要结局
Change in marginal bone loss
时间窗: 2 weeks, 1month, 2 months, and 6 months
To assess the change in marginal bone loss, the linear distance from a fixed reference point-typically the implant shoulder or CEJ-to the highest level of bone-to-tooth/implant contact is measured.
Change in in implant stability
时间窗: Immediately after surgery, 2 months and 6months postoperative.
Ostell device will be used to assess implant stability
次要结局
- Change in bone density(2 weeks, 1month, 2 months, and 6 months)
研究者
Hams Hamed Abdelrahman
Lecturer of Dental Public Health and biostatistical consultanat
Alexandria University