A Pilot Study to compare the Clinical Effectiveness of Dental Implant made in India with a Standard Benchmarked Implant
- Conditions
- Encounter for adjustment and management of other implanted devices,
- Registration Number
- CTRI/2023/04/051641
- Lead Sponsor
- Translational Center of Excellence on Biomaterials for Orthopedic and Dental Applications
- Brief Summary
Abstract- The current status of the Indian population reveals that over half of the population hasexperienced tooth loss. The level of complete edentulism in general population varies from 14-16%mostly in the 60-year age group. Higher edentulism in both urban and rural elderly population isaround 91.2% in elderly above the age of 65 years. Over and above, fastest growing population,rapid westernization and a lack of resources are increasing the burden of oral diseases in ourcountry. More than 80% of dental surgeons are catering to the needs of 20% of the population inurban areas, while almost no dental treatment facility is available to 80% of the population living inthe rural areas.A dental implant is an artificial tooth root made of a natural and/synthetic biomaterial. The implant isused to support a dental prosthesis (implant-supported crown, bridge or denture), that resemblesnatural tooth. A typical dental implant system consists of metallic tooth root and attachmentcomponents made of metal (preferably titanium alloy) to support a dental prosthesis. The systemconsists of an ‘implant’ part which goes into the bone and provides a stable anchorage, and an‘abutment’ part which connects the prosthetic crown to the implant.Biocompatibility of biomedical grade titanium alloy (Ti6Al4V) is well established in clinical settings.Food and Drug Administration (FDA, US) has already approved Ti6Al4V as a biocompatiblematerial with no reported health issues in case of implant surgeries. Therefore, it has been reportedthat Ti6Al4V is one of the safest biomaterials in the context of cytocompatibility and post-implantcompatibility. Additionally, Ti6Al4V is approved as an excellent biocompatible material for surgicalimplant applications by ASTM (ASTM F136, appendix X2).In the light of these positive reports from literature, for the present study a novel design of dentalimplant screw is innovated and manufactured using biomedical grade titanium alloy (Ti6Al4V). As apart of clinical study, we would like to conduct an in vitro study for these dental implant screwfabricated using computer numerical control (CNC) machining and electrical discharge machining(EDM), in human. We would like to evaluate the clinical efficacy of these implant dental screw inenhancing the bone formation around implant after its implantation in human.Methodology: The type of dental implant surgery depends on the type of the implant andconditions of the jawbone. Dental implants require one or more surgical procedure based on thetype of loading and location of the missing tooth. Since it requires surgical procedures, the patientcondition will be evaluated thoroughly in the presence of a team of specialized doctors. Afterreviewing the oral health, Cone Beam Computed Tomography (CBCT) scan will be used todetermine the bone quality and the implant orientation in the jawbone. This clinical trial will mostlyrequire two stage surgery and will be done when no immediate loading will be required. Local orgeneral anesthesia will be given depending on the need of the patients. Implantation sitepreparation will be performed in the sterile conditions. Then a mid-crestal will be given and the gumflap will be elevated to expose the crestal part of the bone ridge. After exposing the underlying boneridge, reference of adjacent teeth will be taken to prepare osteotomy at the implant site for futureprosthesis. Depending the density of bone, a series of drills from pilot drill to final drill will be done atclinically acceptable speed range by using a surgical drilling unit with good control of torque andirrigation of chilled saline to avoid the bone heating and necrosis of the bone. Pilot drilling will befollowed by the depth drilling and osteotomy widening. After the final assessment of prepared osteotomy, the sterile implant (Ti6Al4V) will be screwed in at very low speed using hand rachet orrotary handpiece such that all the threads should get submerged into the bone. Following implantinsertion, the sterile cover screw will be screwed over the implant screw using allen keys. Afterinserting the cover screw, the gum flap will be sutured back with resorbable suture. Implant will beallowed to heal, with loading or micro movement, for a period to allow osseointegration (2 – 4months). In the second stage surgery, the implant will be uncovered and healing abutment isconnected to form the gingival contour around it. After doing impression and fabrication ofprosthesis, prosthesis seated on the final abutment will be screwed over the implant screw by usingmechanical rachet at torque 30-35 N.cm. Then the gum tissue is closed around the abutment withresorbable stitch. After 5-6 months (or as required) of insertions of complete implant assembly,patients will be scheduled for a serials follow-up visit at intervals of four months and twelve monthsto look for the issues like implant loosening, periodontal disease etc., which will lead to further bonemanipulation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 20
- Absence of mandibular first molar unilaterally.
- Bounded edentulous space with natural teeth with minimum period of 4 months after extraction.
- More than 2 mm thickness of keratinised tissue around planned edentulous site.
- Presence of opposing natural dentition with normal occlusion.
- Good to fair oral hygiene.
No systemic disease Presence of any local risk factor like insufficient crown space or infected site History of smoking Bruxism and other parafunctional oral habits Lactating and pregnant women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mean crestal bone loss Baseline, 4 and 12 months
- Secondary Outcome Measures
Name Time Method Longevity of restoration and technical complication. Marginal bone loss and probing depth of soft tissue.
Trial Locations
- Locations (1)
Faculty of Dental Sciences
🇮🇳Bangalore, KARNATAKA, India
Faculty of Dental Sciences🇮🇳Bangalore, KARNATAKA, IndiaDr Vibha ShettyPrincipal investigator9845305455vibshetty6@gmail.com