Evaluation and Comparison of clinical efficacy of indigenously designed and produced titanium dental implant system with hybrid threads and anti-rotational features with Straumann implant: A randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- 1. Implant Survival
研究概览
简要总结
A dental implant is an artificial tooth root made of a naturaland/or synthetic biomaterial. Biocompatibility of biomedical grade titanium alloy (Ti6Al4V) is wellestablished in clinical settings. Food and Drug Administration (FDA, US) hasalready approved Ti6Al4V as a biocompatible material with no reported healthissues in case of implant surgeries. In the presentstudy, a novel design of dental implant screw is innovated and manufacturedusing biomedical grade titanium alloy (Ti6Al4V). Further, this indigenous dentalimplant system is surface modified using sandblasting and acid etching inorder to enhance and promote the process of osseointegration. As a part of a clinical study, we would like to conduct a clinical study for thesedental implant screws fabricated using computer numerical control (CNC) machiningand electrical discharge machining (EDM), in humans. The ingenious implant will be compared with the commercially and clinically available Straumann implants. We would like to evaluatethe good clinical outcomes after the placement of the newly deisgned implants. The hypothesis of the study is that "Surface modifiedindigenouslydesigned and produced titanium dental implant system with hybrid threads andanti-rotational features demonstrate clinically relevant implant success rate."
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Absence of one/two tooth bilaterally in maxilla or mandible
- •Periodontal Healthy Adults above 18 years of age
- •Good general health of the individuals whose ASA score is 1-2
- •Absence of systemic diseases.
- •Sufficient bone volume with 4 months post- extraction healing time 6.Patient giving his/her informed consent and willing to participate in the study.
排除标准
- •Immunocompromised patients
- •Poor oral hygiene
- •Adults with parafunctional habits like bruxism etc.
- •Pregnant woman or breastfeeding.
- •Heavy smoker; more than 10 cigarettes in a day.
- •Patients on systemic corticosteroids for long term
- •Patients with history of radiation therapy in the head and neck region.
- •Refusal of patient to participate in the study.
结局指标
主要结局
1. Implant Survival
时间窗: At 6 and 12 months from baseline
2. Implant Success
时间窗: At 6 and 12 months from baseline
3. Mean Bone level as evaluated using radiograph
时间窗: At 6 and 12 months from baseline
次要结局
- 1. Mean osseointegration period(2. Dental Plaque Assessment)
