A pilot study to assess the safety and efficacy of developed nano-surface dentalimplants.
- Conditions
- Health Condition 1: K084- Partial loss of teeth
- Registration Number
- CTRI/2023/07/054793
- Lead Sponsor
- Council of Scientific and Industrial Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome variable â?? Implant survival rate at 1 yearTimepoint: 6 months, 1 year
- Secondary Outcome Measures
Name Time Method Implant Insertion TorqueTimepoint: At implant surgery;Implant stability by RFATimepoint: at implant insertion, 4, 8, & 12 weeks;Peri implant Probing DepthTimepoint: At 6 months & 1 year;Peri-implant crestal bone levelTimepoint: At Baseline, 6 months, & 1 year;PI, BOP ,GI, impl. Mobility & <br/ ><br>Discomfort, Suppuration, or any other Biological complicationsTimepoint: During 1 year follow up;Prosthetic Evaluation- Any prosthetic complications such as abutment screw loosening, fracture of abutment screw, prosthesis, abutment, implant.Timepoint: During 1 year