CTRI/2023/07/054793尚未招募1 期
Evaluation of efficacy and safetyof indigenously manufactured Nano-surface dental implants - NI
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Age: 18 to 65 years.
- •2. Partially edentulous maxilla or mandible.
- •3. Adequate oral hygiene. The patient has to qualify for good or fair score as per Oral Hygiene Index- Simplified by Green & Vermillion1964. (OHI-S).
- •4. No active periodontal disease at the time of selection. The periodontal condition is considered acceptable when the full mouth bleeding on probing (BOP) score is less than 20%.
- •5. Sufficient Bone volume at the proposed implant site, as assessed via clinical and radiological examination, with a minimum of 2 mm safety margin from limiting anatomical landmarks and at least 1 mm of bone available buccally and lingually beyond the proposed implant. The span should allow at least 1.5 mm distance between the implant and adjacent tooth/teeth following placement.
- •6. Edentulous span opposed by natural dentition or prosthetic restoration.
- •7. Patient willing to give informed consent.
排除标准
- •1. Systemic diseases that contraindicate surgery or compromise the prognosis according to criteria given by American society of Anesthesiologists
- •2. History of radiation therapy
- •3. Patients on intravenous bisphosphonates medication or on oral bisphosphonates for greater than 3 years or with concomitant steroids.
- •4. History and clinical evidence of parafunctional habits like bruxism and clenching.
- •5. Smoking more than 10 cigarettes per day. Alcohol or drug abuse.
- •6. Unfavourable skeletal inter-maxillary relation including severe Class II and Class III.
- •7. Unfavourable crown-height space less than 7 mm which would preclude cementable prosthesis.
- •8. Reduced mouth opening compromising the access to the area.
- •9. Active Occluso-muscular â?? Temporomandibular conditions.
- •10. Reduced compliance or poor oral hygiene.
- •11. Current Pregnancy or female patient intending to get pregnant during the course of the study.
研究者
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