Prof. Naresh Bhatnagar,
Professor of Mechanical Engineering,
Indian Institute of Technology, Delhi

Idea to Reality:Glimpses of Dental Implant System Development at IIT Delhi (2007-2024)

Abstract: The first design was developed by a synergistic effort of a team of doctors and engineers from the two partnering institutes under the aegis of CSIR-NMITLI program. The manufacturing of a complete dental implant system at IITD followed this with continuous inputs by the doctors from Maulana Azad Institute of Dental Sciences (MAIDS) Delhi since 2007. 

The first design was based on the premise of minimum stress generation (use of FEM techniques) during the insertion of a threaded Titanium Ti6Al4V implant into a human bone for better osseointegration, a multi-function abutment for reduced inventory and for all sizes of implants  (3.2 mm to 5.0 mm of diameter based on Indian anthropometry) to reduce cost. The innovations include the use of same prosthetic platform for all the implant diameters (3.2, 4.0, 4.5, 5.0), integrated platform switching and the development of a single component which serves as implant mount, implant impression, transfer coping and as the final straight abutment. The surface treatment technology for the implant was developed in house, which was the key for the success of this implant.

Patents: This resulted into several novel features of design and innovations, which led to the filing of an Indian Patent (2243/DEL/ 2007 ref 189/07), a PCT (PCT WO/2009/054005) and eventually a US Patent application (US2011/0117522A1) in May 2011. The US patent was finally awarded in Dec 2017 – a long journey for medical products: US Pat No. 9,833,300. Later on there are more patents on Lobular implant and Drug eluting Nano surface dental implants

Development of complete prosthetic and surgical kit: A surgical kit containing all types of surgical drills and other surgical components along with prosthetic components like analogs was also indigenously designed and developed under this project leading to design and fabrication of precise components on a 10-Axis CNC machine installed at IITD.

Preliminary efficacy and safety studies: The biological efficacy and safety was established with an animal study whose results were verified with Micro CT analysis and Histomorphometry at Sree Chitra Tirunal Institute for Medical Sciences & Technology (SCTIMST), Thiruvanthapuram and at Shriram Institute for Industrial research, Delhi. An initial clinical use of the implant was done at MAIDS with the registration at CTRI being – CTRI/2011/11/002149. The survival rate was 92% in case of IITD implants while it was 90% in case of control for Phase 1. Thus the preliminary success was established in efficacy and safety.  This led to the development of further component design including angular abutments, ball abutments, one stage implant, bi-cortical implants with refined processing, cleaning and packaging as per ISO14385 (GMP) for Phase 2 multi centric trials for more than 150 cases. 

After the success of this IITD product and underlying technology based on detailed research and on the fact that there was an almost 100% import including low cost Chinese, Korean and Israeli implants, CSIR called for expression of interest from national industry and IITD handed over this home grown interdisciplinary research based technology in 2017, the commercial launch was accomplished with now CE marked export from India. The destination of the long journey to overcome all the valleys of death is wonderful.
The glimpses of future 3rd and 4th Generation of implants will be shared in this seminar, along with other Medtech products to showcase interdisciplinary engineering innovations(if time permits).

Speaker Bio: Prof. Naresh Bhatnagar completed his PhD in 1992 from IIT Bombay and worked in Industry FIAT Auto before joining academics at IITD in 1998 in Mechanical Engineering Department. Last 26 years at IIT Delhi has seen him venturing into multidisciplinary research cutting across departments / centers/ institute and country in the areas of polymers, composites, material processing, machining, medical devices, etc leading to several products, biomedical implants, novel biomaterials, nano composites, microcellular polymers based porous plastic products, BVS scaffolds and new ways of testing and characterization of polymeric composites and related manufacturing technologies, apart from recent defense and security related products like Bullet Proof Jacket (BPJ), personal protection equipments for the nation. He has supervised 44 PhD (8 are ongoing), 90 M.Tech, 14 MDS (Master of Dental Surgery), 3 DM/MCh thesis in variety of areas related to materials, manufacturing, medical devices like Dental, Orthopedic, Cardiac, ENT and Cancer implants. He has published 200+ International peer reviewed journal articles and 200+ in international conferences with more then 25 Indian patents (1 US patent). He was the National Domain leader on “Defense & Security” of IMPRINT 1 India initiative. He is an invited expert member of several expert committees of CSIR, DST, DRDO, DBT, BPRND, MHA, NITI Aayog and UPSC.

He has transferred the following technologies to the industry:

  1. Hip protection Device for the Elderly (Tro-Guard) – to prevent the fracture of hip joint during a sudden fall  (available at Amazon.in by Ozla Healthcare http://www.ozlahealthcare.com/products.php?cid=Mjg
  1. Dental Implant System (i-Fix) – the first dental implant being manufactured in India with R&D support by IITD to IMPL, https://www.impllife.com/our-research-partners/
  2. Advance Ballistics for High Energy Defeat (ABHED) Bullet Proof Jacket to three Indian industries; MIDHANI, MKU and SMPP for mass manufacturing and supply to Indian Army and other Security agencies. https://www.linkedin.com/posts/iitdelhi_drdo-industry-academia-center-of-excellence-activity-7275484285229264897-gf6n?utm_source=share&utm_medium=member_desktop&rcm=ACoAADcit8kBPlyYXRMBKNoXe-IcBA7JxFoccRA

The other technologies ready for tech transfer are:

  1. Polycentric Polymeric Knee joint for Amputees
  2. Injection molded Drop lock knee joint for Polio and Cerebral Palsy patients
  3. Cementless femoral stems for THR
  4. Breast Cancer Tumor marker for adjuvant chemotherapy and breast preservation
  5. Ice Axe, Boot Crampons for Glaciated domains of Indian Army
  6. Blast Proof material system for vehicle and structures

The current research and development is as under:

  1. Bioresorbable Vascular Stents (BVS)
  2. Trans catheter Aortic Valve (TAVI/ TAVR)
  3. Indwelling Voice Prosthesis
  4. Drug Eluting Dental Implants