Comparative evaluation of implant stability quotient and marginal bone loss in conventional and Ultraviolet light photofunctionalized dental implant retained mandibular overdenture in patients with moderately controlled Diabetes Mellitus a randomized controlled clinical study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- implant stability quotient and
研究概览
简要总结
This is paired split mouth randomised controlled trial comparing and evaluating the implant stability and marginal bone loss is of photofunctionalized implant and conventional implant in moderately controlled diabetic patients receiving mandibular overdenture. As a part of routine blood investigation for implant placement blood sugar levels and HbA1c levels shall be obtained. Patients will be recruited after giving participation participant information sheet in the simplified language and after taking the consent for the trial. A total of 26 implants in 13 moderately controlled diabetic patients, one photofunctionalized and other conventional implants will be randomly allocated in each patient’s left or right side of the mandible as per the computer-generated random numbers. Radiographic evaluation will be done with the help of three dimensional cone beam computed tomography to evaluate the length and width of available bone and accordingly, dimensions of dental implants will be selected for placement. Implants shall be placed with conventional surgical drilling protocol as advocated by the implant manufacturer. On all the placed implants gingival former will be planned and primary closure shall be achieved by sutures. The specimens of one group of implants will be treated using a customized photofunctionalization unit for 15 minutes and then placement will be done. The light source used will be a 125-watt to 250-watt medium-pressure mercury (Hg) lamp with dual lamp monitoring.The wavelength of the light used UV-C will be 250–260 nm As per the protocol, conventional loading shall be done after three months. Patients will be given conventional maxillary denture and lower implant supported ball attachment retained overdenture and outcomes will be measured by Implant stability instrument Resonance Frequency Analysis (RFA) at baseline 2 3 6 and 12 months and assessment of marginal bone level will be checked at baseline 2 3 6 and 12 months after implant placement with intraoral periapical radiograph. Results will be statistically evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •a Subjects 18 years and above b Completely edentulous upper and lower arches c Edentulous ridge classification as per American College of Prosthodontists (ACP) type III & type lV d Able to provide consent e Patients with moderately controlled type 2 diabetes mellitus f HbA1C value 6.9-8.0 g Patients whose consent for surgical placement of implants is obtained from physician treating them for diabetes.
排除标准
- •a Patients with systemic diseases or metabolic disorders other than diabetes if any which may impact study b Patients is currently a smoker or quit smoking less than 1 year c Pregnant and lactating women d Patients in whom bone grafting is indicated along with the placement of implants e Patients in whom immediate implants are placed f Patients who have received or are on chemotherapy or radiotherapy or drugs that interfere with implant integration g Patients having any surgical or congenital mandibular defects.
结局指标
主要结局
implant stability quotient and
时间窗: implant stability quotient and marginal bone loss at baseline 2 months 3 months 6 months and 12 months
marginal bone loss
时间窗: implant stability quotient and marginal bone loss at baseline 2 months 3 months 6 months and 12 months
次要结局
未报告次要终点
研究者
Dr Harshal Shailesh Jain
K M Shah Dental College and Hospital