| CTRI Number |
CTRI/2023/04/051641 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
15/04/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Pilot Study to compare the Clinical Effectiveness of Dental Implant made in India with a Standard Benchmarked Implant |
|
Scientific Title of Study
|
A Pilot Study to Evaluate the Clinical Efficacy of Indigenously Designed and Manufactured
Titanium Dental Implant System with Hybrid Threads and Anti-rotational Features |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vibha Shetty |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Room no 6, First floor
Department Of Prosthodontics and Implantology
Faculty Of Dental Sciences
Ramaiah University of Applied Sciences
Bangalore
KARNATAKA
560054
India |
| Phone |
9845305455 |
| Fax |
|
| Email |
vibshetty6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vibha Shetty |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Room no 6, First floor
Department Of Prosthodontics and Implantology
Faculty Of Dental Sciences
Ramaiah University of Applied Sciences
Bangalore
KARNATAKA
560054
India |
| Phone |
9845305455 |
| Fax |
|
| Email |
vibshetty6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vibha Shetty |
| Designation |
Professor |
| Affiliation |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
| Address |
Room no 6, First floor
Department Of Prosthodontics and Implantology
Faculty Of Dental Sciences
Ramaiah University of Applied Sciences
Bangalore
KARNATAKA
560054
India |
| Phone |
9845305455 |
| Fax |
|
| Email |
vibshetty6@gmail.com |
|
|
Source of Monetary or Material Support
|
| Project is supported by Translational Centre of excellence on biomaterials for orthopedic and dental applications, Department of Biotechnology, New Delhi and TATA Steel New Materials
Business |
|
|
Primary Sponsor
|
| Name |
Translational Center of Excellence on Biomaterials for Orthopedic and Dental Applications |
| Address |
Translational Center of Excellence on Biomaterials for Orthopedic and Dental Applications, Department of Biotechnology, Govt. of India |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| TATA Steel New Materials Business |
TATA Steel New Materials Business |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vibha Shetty |
Faculty of Dental Sciences |
Room no. 6, First floor, Faculty of Dental Sciences
Ramaiah university of Applied Sciences
GNANAGANGOTHRI CAMPUS
New BEL Road, MSR Nagar
Bangalore - 560054
Bangalore
KARNATAKA |
9845305455
vibshetty6@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human trials of MS Ramaiah University of Applied Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z458||Encounter for adjustment and management of other implanted devices, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Straumann bone level tapered
implant |
Duration is for 1 year |
| Intervention |
Ti6Al4V based three-piece
dental implant system |
Duration of intervention is 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
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.
Presence of adequate bone around implant and vital structure.
Good to fair oral hygiene
|
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| mean crestal bone loss |
Baseline, 4 and 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Longevity of restoration and technical complication.
Marginal bone loss and probing depth of soft tissue.
Cone beam computed tomography (CBCT) analysis to quantify hard tissue stability or loss
around the crest of the coated implant.
Dental implant stability by using Resonance frequency analyser. |
Four and twelve months
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/05/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Abstract- The current status of the Indian population reveals that over half of the population has
experienced 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 is
around 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 our
country. More than 80% of dental surgeons are catering to the needs of 20% of the population in
urban areas, while almost no dental treatment facility is available to 80% of the population living in
the rural areas.
A dental implant is an artificial tooth root made of a natural and/synthetic biomaterial. The implant is
used to support a dental prosthesis (implant-supported crown, bridge or denture), that resembles
natural tooth. A typical dental implant system consists of metallic tooth root and attachment
components made of metal (preferably titanium alloy) to support a dental prosthesis. The system
consists 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 biocompatible
material with no reported health issues in case of implant surgeries. Therefore, it has been reported
that Ti6Al4V is one of the safest biomaterials in the context of cytocompatibility and post-implant
compatibility. Additionally, Ti6Al4V is approved as an excellent biocompatible material for surgical
implant applications by ASTM (ASTM F136, appendix X2).
In the light of these positive reports from literature, for the present study a novel design of dental
implant screw is innovated and manufactured using biomedical grade titanium alloy (Ti6Al4V). As a
part of clinical study, we would like to conduct an in vitro study for these dental implant screw
fabricated 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 in
enhancing the bone formation around implant after its implantation in human.
Methodology: The type of dental implant surgery depends on the type of the implant and
conditions of the jawbone. Dental implants require one or more surgical procedure based on the
type of loading and location of the missing tooth. Since it requires surgical procedures, the patient
condition will be evaluated thoroughly in the presence of a team of specialized doctors. After
reviewing the oral health, Cone Beam Computed Tomography (CBCT) scan will be used to
determine the bone quality and the implant orientation in the jawbone. This clinical trial will mostly
require two stage surgery and will be done when no immediate loading will be required. Local or
general anesthesia will be given depending on the need of the patients. Implantation site
preparation will be performed in the sterile conditions. Then a mid-crestal will be given and the gum
flap will be elevated to expose the crestal part of the bone ridge. After exposing the underlying bone
ridge, reference of adjacent teeth will be taken to prepare osteotomy at the implant site for future
prosthesis. Depending the density of bone, a series of drills from pilot drill to final drill will be done at
clinically acceptable speed range by using a surgical drilling unit with good control of torque and
irrigation of chilled saline to avoid the bone heating and necrosis of the bone. Pilot drilling will be
followed 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 or
rotary handpiece such that all the threads should get submerged into the bone. Following implant
insertion, the sterile cover screw will be screwed over the implant screw using allen keys. After
inserting the cover screw, the gum flap will be sutured back with resorbable suture. Implant will be
allowed to heal, with loading or micro movement, for a period to allow osseointegration (2 – 4
months). In the second stage surgery, the implant will be uncovered and healing abutment is
connected to form the gingival contour around it. After doing impression and fabrication of
prosthesis, prosthesis seated on the final abutment will be screwed over the implant screw by using
mechanical rachet at torque 30-35 N.cm. Then the gum tissue is closed around the abutment with
resorbable 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 months
to look for the issues like implant loosening, periodontal disease etc., which will lead to further bone
manipulation. |