A clinical trial to demonstrate the effectiveness in function of an indigenously developed dental implant system [NMITLI]

Phase 1/2

Completed

Conditions: Partial loss of teeth, partial or complete edentulism,

Registration Number: CTRI/2019/06/019758

Lead Sponsor: Council of Scientific and Industrial Research under NMITLI Nationally Evolved Project

Brief Summary: The present study is a prospective randomized controlled non- inferiority clinical trial with a parallel group hybrid design. Under this project, an indigenous Dental implant was designed on the basis of scientific rationale and experimentally optimized to serve the treatment needs of an edentulous or partially edentulous Indian patient. The prototypes were developed in an in-house facility at IIT Delhi and the surface treatment protocols were developed. In addition, various other components including the surgical and prosthetic ancillaries were developed. The Implants were duly tested for biocompatibility studies (as per ISO 10993) norms and engineering tests for fatigue and other mechanical testing were done at IIT Delhi. A trial in rabbit model was also done to prove the safety and efficacy of the implants as per CPSCEA guidelines and Good laboratory practices and the tests were extremely encouraging.

The protocols were formulated as per the CDSCO guidance document for conducting clinical trials in India and the scientific literature available. The objectives of the study were to compare NMITLI Dental Implants with the standard control implants in single implant situations to analyze the survival rate of implants after one year in function, quantitatively analyze the peri-implant marginal bone loss surrounding the implants after one year in function, evaluate the mechanical complications related to implants and prosthetic restorations, study the outcome of implants in different prosthetic modalities as case series, and determine the undesirable side effects under normal conditions of use and assess whether they constitute any risk when weighed against the intended benefits of the NMITLI implant.

During the study period, a total of 233 implants were placed in 143 patients under various treatment heads (Single unit NMITLI implants with Cementable prosthesis: 134, Controls: 67; Multiunit implant supported bridge: 07 cases with 18 implants; Implant supported Mandibular overdentures: 07 cases with 14 implants)

The primary measure of evaluation was the 12-month survival rate of the implants. Statistical analysis was performed for 127 case and 61 control single site implants, that completed 1 year follow up after prosthetic rehabilitation. The case and control implant groups demonstrated a survival rate of 97% and 100%, respectively, at the end of 12 months. The mean crestal bone loss difference was significant between the two groups at baseline (p value < 0.05). However, at 6 and 12 months the difference between the test and control groups was observed to be insignificant (p value > 0.05).

Conclusion: The survival rate of the test group falls within the previous assumption of a 10% non-inferiority margin. With p value > 0.05, it could be safely stated that the null hypothesis may be accepted for the trial, and the developed implants are non-inferior to the standard implants at sample allocation ratio of 2:1.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 387

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.
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

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.
History and clinical evidence of parafunctional habits like bruxism and clenching.
Smoking greater than 10 cigarettes per day 6.
Alcohol or drug abuse.
Unfavourable skeletal inter-maxillary relation which includes severe Class II and Class III .
Unfavourable crown-height space less than 7 mm which would preclude cementable prosthesis.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the Marginal Bone Loss of the study implant in comparison to the control implant.	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.
To evaluate the survival rate of the study implant (NMITLI) at 1 year in function and	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 Outcome Measures

Name	Time	Method
implant stability by RFA	At stage 1,2 and prosthesis delivery
presence or absence of perimucositis, periimplantitis	at stage 2 surgery, after prosthesis at 3,6,9,12 months
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.	prosthesis delivery onwards at 3,6,9,12 months.
ImplantInsertion Torque	At stage 1 surgery

Trial Locations

Locations (1): Maulana Azad Institute of Dental Sciences, New Delhi
🇮🇳
Central, DELHI, India
Maulana Azad Institute of Dental Sciences, New Delhi
🇮🇳Central, DELHI, India
Prof Dr Mahesh Verma
Principal investigator
dpmaids@gmail.com