Evaluation of the Effect of Laser Biostimulation on Implant Covered With PRF in Controlled Diabetic Patients: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Per-implant bone density measurements
研究概览
简要总结
the goal of this clinical trial is to evaluate laser biostimulation effect on osseointegration of implant covered by PRF(platelet rich fibrin) in controlled diabetic patients with compromised healing potential.
METHODS: The study was conducted on type 2 controlled diabetic patients receiving 22 implants covered with PRF inserted in posterior maxilla or mandible. Implants were divided randomly into 2 groups. Group1: control group (received no laser irradiation), group2: received diode laser. Peri-implant new bone density and secondary stability were assessed using cone-beam computed tomography and Anycheck device respectively. Density was evaluated immediately post implant insertion and after 5 months, while implant stability was performed 5 months post implant insertion. Statistical analysis was executed significance level P ≤ 0.05.
详细描述
Study type:
randomized controlled clinical trial.
Study design:
Controlled type II diabetic patients with edentulous posterior areas were randomly selected from dental clinic of Medical and Scientific Centre of Excellence (MSCE), National Research Centre (NRC), Cairo, Egypt, according to inclusion and exclusion criteria to receive a total number of twenty-two dental implants. Implants were randomly distributed with 1:1 allocation ratio into two groups according to exposure to laser irradiation. Group 1 was not exposed to laser irradiation (control group), while group 2 was exposed to laser irradiation. Peri-implant new bone density was evaluated immediately post implant insertion and after 5 months, while secondary implant stability was performed 5 months post implant insertion.
This study was prosecuted with the Code of Ethics of the World Medical Association, they were stated in the Declaration of Helsinki in 1975. Medical Research Ethical Committee of the National Research Centre, Cairo, Egypt permitted this study with approval number (03430423). All patients were familiar with the study's treatment phases and signed a consent form. The study was conducted from January 2023 to March 2024
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Both the participants as in group 1 or control laser device is off (not active)while in group 2 laser device is active. Outcome Assessor is blinded as the cases is coded and unknown for the Assessor
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •nonsmoker patients,
- •age range 30 -60 years,
- •Glycosylated hemoglobin (Hb1C) ranges between 7-8,
- •no other systemic disease,
- •vital signs are normal (blood pressure, temperature, pulse rate, respiratory rate),
- •missing 1st or 2nd mandibular or maxillary premolars or molars,
- •lab investigations are within normal (CBC. liver function AST &ALT, kidney function urea &creatinine, Ca level, 25OH Vit D),
- •no need for alveolar bone grafting, and
- •no soft or hard tissue pathology.
排除标准
- •smoker patient,
- •Glycosylated hemoglobin (Hb1C) more than 8 or less than 7,
- •age less than 30 or more than 60,
- •presence of other systemic diseases,
- •vital signs are not normal,
- •lab investigations are not normal (CBC, liver function, kidney function),
- •need for alveolar bone grafting and
- •present soft or hard tissue pathology.
结局指标
主要结局
Per-implant bone density measurements
时间窗: at immediate day of surgery(baseline) and after 5 months for the same patients
Digital software program was used for quantitative mean bone density measurements of all the captured radiographs produced by CBCT for both groups. Multiplanar resolution screen (MPR) was selected showing radiographic images of the mandible and maxilla in sagittal and coronal views to quantify bone radiodensity in mesiodistal and buccolingual surfaces respectively , a constant exact area was selected for each view with area =1 5.2mm2, width = 2.00mm, and height = 7.60mm. Five readings of radiodensity in Hounsfield units (HU statistics) were collected by blind investigator for each peri-implant surface (mesial, distal, buccal, and lingual) with slice thickness of 0.5mm. Finally, the mean density values were calculated and tabulated concerning sagittal and coronal views in each implant
次要结局
- Implant stability measurements(only after 5 months from implant insertion)
研究者
Said Abd Allah Kamel Taha
Principal investigator
National Research Centre, Egypt