Health Condition 1: null- Partial Edentulism
Conditions
Interventions
Intervention1: Placement of Indigenously manufactured New Millennium Indian Technology Leadership Initiative (NMITLI)Dental Implant: Placement of Indigenously manufactured New Millennium Indian Techno
Sponsors
Maulana Azad Institute of Dental Sciences New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years. 2. Bilateral tooth edentulism in the posterior region (premolars or molars) in the maxilla or mandible presenting a tooth bound tooth edentulous span. 3. No active periodontal disease at the time of selection. Adequate oral hygiene. 4. Healing period of at least 16 weeks following extraction at the implant site. 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 0.5 mm of bone available circumferentially around the implant following placement. 6. Edentulous span opposed by natural dentition or fixed prosthetic restoration and with tooth to two teeth occlusion. 7. Patient willing to give informed consent.
Exclusion criteria
Exclusion criteria: 1. Systemic diseases that contraindicate surgery or compromise the prognosis. 2. History of radiation therapy 3. Patients on bisphosphonates medication 4. Bruxism and clenching. 5. Heavy smoking 6. Alcohol or drug abuse. 7. Unfavourable skeletal ? intermaxillary relation. 8. Crown height space of less than 7 mm. 9. Reduced mouth opening compromising the access to the area 10. Active Occluso-muscular ? Temporomandibular conditions. 11. Reduced compliance or poor oral hygiene. 12. Requirement of implant site modification (bone augmentation) or additional procedures like bone expansion or simultaneous sinus lift and sinus graft procedures. 13. Previous bone grafting procedures in the area of the missing teeth. 14. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The present study intends to evaluate the survival and success rates of NMITLI (New Millennium Indian Technology Leadership Initiative) dental implants in human subjects at 3, 6, and 12 months under function and compare it to a commercially available control implant (Xive, Dentsply Friadent).Timepoint: Resonance frequency Analysis (ISQ) will b done at the time of implant insertion, 1week, 2 week, 3 weeks , 4 weeks, and 12 weeks. Radiographic evaluation of Peri Implant bone levels using Rinn, XCP (Dentsply) will be done at the time of implant insertion, 1week, 2 week, 3 weeks , 4 weeks, and 12 weeks. Tests used to monitor health of peri implant soft tissues will be done after one month, on a monthly basis, till one year post placement of the crown. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the survivability of the study implant (NMITLI) post loading and comparing it to a commercially available established control implant (Frialit, Dentsply)Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactDr Farrukh Faraz
Outcome results
None listed