A randomized clinical study to evaluate the effect of Photobiomodulation therapy using blue light emitting diode in comparison with low level laser on hard and soft tissue healing around dental implants.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- primary stability of dental implant
研究概览
简要总结
Dental implants are the most modern way to replace missing teethwith high success rate. Bone formation at the bone-implant interfaceis critical factor in implant success. Photobiomodulation therapyhas been applied in various clinical situations and has become an attractivealternative to enhance wound healing and bone formation. It involves theapplication of a monochromatic light with a low energy density which inducesnon thermal photochemistry effects on cellular level. But there are very fewclinical studies evaluating its effect on hard and soft tissue around dentalimplants. Also laser equipment being expensive, is not readily available in alldental setups. An alternative cheaper option could be the use of routine dentalcuring light (blue LED).The present study aims at evaluating the effect of BlueLED and LLLT on the hard and soft tissue around dental implants. The study willinvolve 3 groups; control group (no therapy), study group 1 (LLLT) and studygroup 2 (blue LED therapy). The parameters that will be evaluated are primaryand secondary stability of implants, bone density and soft tissue healingaround dental implants at different time intervals. The results will bestatistically analysed to evaluate the outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Males or females requiring replacement of single missing tooth with dental implant.
- •Patients age between 20-45 years.
- •Those who will provide informed consent.
- •Extraction done at least 2 months prior to implant placement.
- •Patients not requiring bone augmentation procedures.
排除标准
- •History of
- •leukocyte dysfunction or deficiencies
- •bleeding disorders
- •neoplastic disease requiring radiation or chemotherapy
- •metabolic bone disorder
- •uncontrolled endocrine disorders
- •HIV infection
- •uncontrolled diabetes
- •patients on immunosuppressive therapy.
- •Alcoholism or drug abuse or heavy smokers and tobacco chewers.
- •History of aggressive periodontitis.
- •Irradiation history
- •Unhealed extraction socket
- •Pregnant women.
结局指标
主要结局
primary stability of dental implant
时间窗: 3 months
次要结局
- bone density around dental implant(3 months)