Health Condition 1: K084- Partial loss of teeth Health Condition 2: null- partial or complete edentulism
Conditions
Interventions
Intervention1: Placement & restoration of indigenously manufactured New Millenium Indian Technology Leadership Initiative (NMITLI) Dental Implant: -Single Tooth Implant with Screw Retained Prosthesi
Sponsors
Council of Scientific and Industrial Research under NMITLI Nationally Evolved Project
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 65 years. 2. Partial or complete edentulism in the maxilla or mandible. 3. Adequate oral hygiene. 4. No active periodontal disease at the time of selection. 5. Healing period of at least 16 weeks following extraction at the implant site. 6. 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 implant following placement. 7. Edentulous span opposed by natural dentition or prosthetic restoration. 8. 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 Anethesiologists 2. History of radiation therapy 3. Patients on intra venous bisphosphonates medication or on oral bisphosphonates for greater than 3 years or with concominant steroids. 4. History and clinical evidence of parafunctional habits like bruxism and clenching. 5. Smoking greater than 10 cigarettes per day 6. Alcohol or drug abuse. 7. Unfavourable skeletal inter-maxillary relation which includes severe Class II and Class III . 8. Unfavourable crown-height space less than 7 mm which would preclude cementable prosthesis. 9. Reduced mouth opening compromising the access to the area 10. Active Occluso-muscular â?? Temporomandibular conditions. 11. Reduced compliance or poor oral hygiene. 12. Current Pregnancy or female patient intending to get pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the Marginal Bone Loss of the study implant in comparison to the control implant. To evaluate the survival rate of the study implant (NMITLI) at 1 year in function andTimepoint: i) From Stage 1 Surgery (BASELINE) to the day of prosthesis delivery. ii) From day of prosthesis delivery to one year after prosthetic loading (function). In this intermediate period, values at 3 months and 6 months and 9 months shall be taken. | — |
Secondary
| Measure | Time frame |
|---|---|
| implant stability by RFATimepoint: At stage 1,2 and prosthesis delivery;ImplantInsertion TorqueTimepoint: At stage 1 surgery;P I ,Probing Depth ,BOP ,GI, impl. Mobility & Discomfort ,Suppuration , PES and Jemt Papilla Index ,Abutment (abt.) fracture, abt. Screw Fracture , prst screw fracture ,Fracture of framework ,Fracture of veneering material ,Loss of retention of prosthesis ,Loss of occlusal screw hole restoration ,abt. screw loosening, prst. screw loosening.Timepoint: prosthesis delivery onwards at 3,6,9,12 months.;presence or absence of perimucositis, periimplantitisTimepoint: at stage 2 surgery, after prosthesis at 3,6,9,12 months | — |
Countries
India
Contacts
Public ContactDr Farrukh Faraz
Maulana Azad Institute of Dental Sciences,New Delhi
Outcome results
None listed