A dental implant, when connected to the jawbone, acts as a base to support one or more artificial tooth.
For most implants in the market, the process to install them is tedious, and bone regrowth and healing takes two to three months, making it a painful experience for patients.
And titanium, which dental implants are made of, comes in a dense solid form, allowing the bone cells to grow only around the implant.
A breakthrough by two Universiti Teknologi Mara (UiTM) researchers recently promises a better alternative ― implants made of bio-compatible nickel-titanium (NiTi) alloy, which are cheaper, effective and easier to install.
The product is a result of collaborative efforts between Associate Professor Dr Muhammad Hussain Ismail, Associate Professor Dr Rohana Ahmad and a local medical device start-up company called Nitium Technology.
The first of its kind, the implant’s NiTi elements bear the closest resemblance to the mechanical properties of human bone.
The implant’s threaded design and its porous structure produces sufficient roughness in ensuring stability and strength.
Dr Rohana, a lecturer at UiTM’s Dental Faculty, said: “This porous implant promotes bone in-growth ― the process where bone cells grow into the pores ― therefore achieving faster and better implant stability.
“This, in turn, will speed up bone regeneration to approximately six weeks.”
Dr Rohana, who is a dental prostheses (prosthodontics) consultant, added that her team hoped to produce shorter implants to be used in areas of the jaw where there is bone deficiency.
“This especially applies to the back of the upper jaw. The upper jaw usually has lower bone quality and is associated with lower implant success rate.
“Hence, we hope our implants will be the solution to this problem,” she said.
The dental implant material is the brainchild of Hussain, who completed his PhD research in porous NiTi and metal injection moulding at the University of Sheffield in the United Kingdom in 2012.
The collaboration was set in motion when Hussain showcased his bone-replacement material at the Malaysian Technology Development Corporation’s Graduate Entrepreneurship Programme (Symbiosis) 2014.
Hussain, who is now UiTM Mechanical Engineering Faculty deputy dean, said: “At that point of time, I didn’t have any specific implant in mind. My PhD research was on a cylindrical sample of NiTi alloy that could be used to make any medical implant.”
At Symbiosis 2014, a partnership was formed between the researcher and Nitium Technology founder and chief executive officer, Muhammad Asif Ahmad Khushaini, to commercialise the alloy.
Asif, 30, who holds a Masters in Theoretical and Mathematical Physics from UiTM, said he always aspired to lead a hard-tech start-up.
“When I met Hussain at Symbiosis, where I was introduced to his discovery, I knew this would be a great opportunity. To date, there is no notable hard-tech start-up in Southeast Asia, so the race to be the first is on,” said Asif, who manages the company with his co-founder, Zul Iman Mohd Yusuf.
After deciding that dental implants would be their first project, Nitium Technology sought Rohana’s expertise.
The first step was to conduct a bio-compatibility study, which determined whether a new medical device could be used without adverse effects or pose biological risks to organic tissues.
The bio-compatibility study was conducted at UiTM, Universiti Kebangsaan Malaysia (UKM), Sirim QAS International and a clinical research organisation in India.
Hussain manufactured his prototypes using the powder metallurgy method ― a process of turning metal into fine powder, which could be sintered or heated to form objects.
“The powder metallurgy method used to make our implant has reduced the production cost by 60 per cent,” he said.
However, they had to overcome challenges in getting the bio-compatibility test off the ground.
Hussain said: “One of the most important aspects in powder metallurgy is particle size. When we first tried to replicate the formulation, things turned out not as we expected. We mixed the mould in UiTM. I remember during the first prototype production in 2016, we had to work until two in the morning during the fasting month.
“The metal injection process was conducted at Sirim Shah Alam and later Sirim Penang, where they had the vacuum furnace that we needed.
“In Malaysia, only three such machines exist and Sirim Penang is the only place where we could sinter 200 to 300 pieces of prototypes at one time,” said the deputy dean.
Asif added: “For pre-clinical studies, we have to produce more than 100 prototypes. At that time, I was about to go to South Korea to join the K-Startup Grand Challenge, so we needed to bring some prototypes there.”
However, as the product was still in an early stage, Nitium Technology had to pull out of the programme.
Hussain, who made some modifications in the second prototype, said: “We modified the powder particle size and binder characteristics. Thankfully, it resulted in very good flow and excellent pore distribution, thus we produced more than 200 pieces for the second prototype.”
Last year, the start-up was invited to rejoin the South Korean programme, and Nitium Technology successfully made to the list of the world’s top 40 start-ups.
“It was then that we met investor Anderson Kang, who became the chief executive officer of our company’s subsidiary, Nitium Technology Korea,” said Asif.
The team proceeded to evaluate the suitability of the second prototype in an animal study. The study was more stringent and had to be conducted in a Good Laboratory Practice-certified laboratory.
Dr Rohana said: “We carried out the study in Universiti Sains Malaysia (USM) under strict regulations. Samples of the implants were inserted into a rabbit’s femur or thigh bone.”
The prosthodontist said the challenges they faced during that stage included a high cost and the animals’ sensitive nature.
“The implants were placed in the animals for three months. Rabbits have lower bone density than humans, so we had to be very careful.
“After the period, we conducted a histological study to see how the bone cells had grown into the porous structure. We also used micro-computed tomography to see the bone growth.
“We’re still analysing the results and from what we have seen, the cells have responded very well. The results will be published in a scientific journal. Before using a new product, any dentist would want to see the evidence,” said Dr Rohana.
Through the South Korean Tech Incubator Programme for Start-up (TIPS), Nitium Technology had secured funding from the South Korean government and a venture capital called Bigbang Angels for an upcoming clinical study.
In collaboration with the Seoul National University Dental Hospital, the start-up is planning a preparation programme for dentists called the Dental Implant Academy.
Hosting 40 dentists from Malaysia, Indonesia, Thailand and the Philippines, the academy will act as another means of revenue for this project.
To date, the project has received approximately RM3.8 million capital from Malaysia’s Cradle Fund, the Malaysian Education Ministry’s Prototype Development Research Grant Scheme, the then Science, Technology and Innovation Ministry’s social innovation fund and TIPS.
Upon completion, the dental implant is expected to be launched next year to an estimated market size of US$8.3 billion (RM34.4 billion).
Asif said: “We will be focusing on two regions ― East Asia and Southeast Asia ― before venturing to other parts of the world.”
The Health Ministry’s Oral Health Programme Annual Report 2016 reported that 21.4 per cent of Malaysians aged 75 and above are edentulous, or do not have natural teeth anymore.