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A pilot study to assess the safety and efficacy of developed nano-surface dental implants.

Evaluation of efficacy and safety of indigenously manufactured Nano-surface dental implants - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/07/054793
Enrollment
60
Registered
2023-07-05
Start date
Unknown
Completion date
Unknown
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K084- Partial loss of teeth

Interventions

Intervention1: Placement & restoration of indigenously developed Nano-surface dental implant in partially edentulous patients, under New Millennium Indian Technology Leadership Initiative (NMITLI) of

Sponsors

Council of Scientific and Industrial Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Primary outcome variable â?? Implant survival rate at 1 yearTimepoint: 6 months, 1 year

Secondary

MeasureTime frame
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 & 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

Countries

India

Contacts

Public ContactProf Dr Farrukh Faraz

Maulana Azad Institute Of Dental Sciences

nmitliphase2@gmail.com01123233925

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026