A clinical trial to demonstrate the effectiveness in function of an indigenously developed dental implant system (NMITLI)
- Conditions
- Health Condition 1: null- Partial Edentulism
- Registration Number
- CTRI/2011/11/002149
- Lead Sponsor
- Maulana Azad Institute of Dental Sciences New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br/ ><br>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. <br/ ><br>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 Outcome Measures
Name Time Method 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