Clinical Evaluation of Dental Implant Stability Placed in Healed Bony Sites Using Oversized Drilling Versus Conventional Drilling Protocol: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Implant stability quotient (ISQ)
研究概览
简要总结
The goal of this [type of study: clinical trial] is to [investigate the influence of Oversized Drilling Versus Traditional for implant Stability and Crestal Bone Loss.] in [ Healthy Patient aged between 20 and 60 years with one missing tooth in the posterior mandible with sufficient bone dimensions].
The main question[s] it aims to answer are:
the influence of oversized drilling versus traditional drilling in the mandibular arch, in terms of implant stability and crestal bone levels. The effects of oversized protocol have not been fully explored on the more compact mandibular bone.
Participants will Control Group: Under-sized drilling group (UD):
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant. Intervention Group: oversized drilling (OD) Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
- Once the osteotomy is ready, the appropriate implant will be placed manually at first and then progressed using a ratchet.
- After the implant is correctly placed, a smart peg will be attached to the implant via hand screwing, to measure its stability using Ostell and four readings will be recorded: a mesial, distal, buccal and lingual reading.
- The smart peg will then be removed and will be replaced with a healing collar above the gingival margin.
- The flap will then be sutured back to its original position around the healing collar with an interrupted suture.
- A standardized digital periapical radiograph will be taken using a radiographic holder and a custom-made radiographic stent to determine the initial crestal bone level.
详细描述
• Pre-operative evaluation
Clinical examination:
- Evaluation of the general condition of the oral cavity of the patients will be performed to make sure it will comply with the criteria required to be enrolled in the study in terms of oral hygiene, pathological conditions, and inter-arch space.
- When the patients meet the clinical selection criteria, radiographic examination will follow.
Radiographic examination:
- A pre-operative periapical x-ray will be performed for each of the patients who met the clinical selection criteria to increase chances of eligibility prior to a pre-operative Cone Beam Computed Tomography (CBCT). This will be done to avoid unnecessary extra expenses of a CBCT and unnecessary radiation exposure.
- A pre-operative CBCT will be performed for each of the patients who met the clinical and primary radiographic selection criteria to ensure eligibility prior to the surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomly selected into either group using computer generated randomization using (www.randomizer.org).
The randomized numbers will be allocated to each site in each patient and will be placed in opaque, sealed and sequentially numbered envelopes. Patients will be randomly allocated to test and control groups using the randomization schedule.
Masking/blinding:
- Participants will be blinded.
- Blinding of the operator will not be applicable
- The outcome assessor will be blinded
- The biostatistician will be blinded
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with a single missing tooth in the posterior region of the mandibular arch.
- •Bone dimensions buccolingual (not less than 6mm) and apicocoronal (not less than 10mm)
- •Patients with healthy systemic condition. (Brightman. 1994)
- •Patients aged from 20 to 60 years old.
- •Good oral hygiene. (Wiesner et al. 2010)
- •Accepts 6 months follow-up period (cooperative patients)
排除标准
- •Patients with signs of acute infection related to the area of interest.
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as parafunctional habits or alcoholism (Lobbezoo et al. 2006).
- •Smokers (Bruno Ramos Chrcanovic et al. 2015) (25).
- •Pregnant women
- •Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy).
研究组 & 干预措施
Control Group: Under-sized drilling group (UD)
Manufacturer-recommended implant osteotomy preparation will be done according to the manufacturer guidelines with the final drill the same diameter of the implant.
干预措施: implant placment (Procedure)
Intervention Group: oversized drilling (OD)
Osteotomy preparations for the oversized drilling group will include an extra drill, which will be 0.2mm wider than the diameter of the implant.
干预措施: implant placment (Procedure)
结局指标
主要结局
Implant stability quotient (ISQ)
时间窗: 1 week, 2 weeks, 3 weeks, 4 weeks, 6 weeks, 8 weeks, and 12 weeks postoperatively.
resonance frequency analysis
次要结局
- • crestal bone levels (day of the surgery (baseline), at 3 and 6 months postoperatively) • pain • swelling • satisfaction • implant survival((day of the surgery (baseline), at 3 and 6 months postoperatively))
研究者
ِAmr Said Ahmed el sayed el shikh
Masters student
Cairo University