| CTRI Number |
CTRI/2022/06/043437 [Registered on: 22/06/2022] Trial Registered Prospectively |
| Last Modified On: |
20/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A randomized controlled clinical trial to evaluate the clinical efficacy of indigenously designed and produced titanium dental implant |
|
Scientific Title of Study
|
Evaluation and Comparison of clinical efficacy of indigenously designed and produced titanium dental implant system with hybrid threads and anti-rotational features with Straumann implant: A randomized controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Departmentof Periodontology and Implant Dentistry,
Room 103, Ground Floor,
Sharad Pawar Dental College and Hospital,
Sawangi (Meghe) Wardha Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Jaiswal |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Departmentof Periodontology and Implant Dentistry,
Room 103, Ground Floor,
Sharad Pawar Dental College and Hospital,
Sawangi (Meghe) Wardha Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9960713010 |
| Fax |
|
| Email |
priyanka.banode@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhairavi Kale |
| Designation |
Assistant Professor |
| Affiliation |
Datta Meghe Institute of Medical Sciences |
| Address |
Departmentof Periodontology and Implant Dentistry,
Room 103, Ground Floor,
Sharad Pawar Dental College and Hospital,
Sawangi (Meghe) Wardha Maharashtra 442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975650669 |
| Fax |
|
| Email |
bhairavikale25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Medical Sciences, Sawangi (Meghe), Wardha
Maharashtra
442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Medical Sciences |
| Address |
Sawangi (Meghe), Wardha
Maharashtra
442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhairavi Kale |
Department of Periodontology and Implant Dentistry |
Room No: 103,
Ground Floor,
Sharad Pawar Dental College and Hopsital,
Sawangi (M), Wardha
442001
Wardha
MAHARASHTRA |
9975650669
bhairavikale25@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIMS Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Straumann® Implant |
The Straumann® Bone Level implant (SLA treated) with tapered profile of same dimensions (diameter and length) as indigenous implants will be used as control group implants |
| Intervention |
The new titanium implant system |
The new implant system with a tapered screw profile of 4.7 mm diameter and 12 mm-6 mm length will be used for implantation. The implant system will be permanently fixed in the oral cavity to restore the tooth function and aesthetics. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Absence of one/two tooth bilaterally in maxilla
or mandible
2. Periodontal Healthy Adults above 18 years of
age
3. Good general health of the individuals whose
ASA score is 1-2
4. Absence of systemic diseases.
5. Sufficient bone volume with 4 months post-
extraction healing time
6.Patient giving his/her informed consent and
willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Immunocompromised patients
2. Poor oral hygiene
3. Adults with parafunctional habits like bruxism
etc.
4. Adults with allergy to titanium or titanium
alloys.
5. Pregnant woman or breastfeeding.
6. Heavy smoker; more than 10 cigarettes in a
day.
7. Patients on systemic corticosteroids for
long term
8. Patients with history of radiation therapy
in the head and neck region.
9. Refusal of patient to participate in the
study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Implant Survival
2. Implant Success
3. Mean Bone level as evaluated using radiograph |
At 6 and 12 months from baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Mean osseointegration period
2. Dental Plaque Assessment
3. Papillary Bleeding Index
4. Periodontal Pocket Depth |
At 3, 6 and 12 months from baseline |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
27/06/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A dental implant is an artificial tooth root made of a natural
and/or synthetic biomaterial. 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. In the present
study, a novel design of dental implant screw is innovated and manufactured
using biomedical grade titanium alloy (Ti6Al4V). Further, this indigenous dental
implant system is surface modified using sandblasting and acid etching in
order to enhance and promote the process of osseointegration. As a part of a clinical study, we would like to conduct a clinical study for these
dental implant screws fabricated using computer numerical control (CNC) machining
and electrical discharge machining (EDM), in humans. The ingenious implant will be compared with the commercially and clinically available Straumann implants. We would like to evaluate
the good clinical outcomes after the placement of the newly deisgned implants. The hypothesis of the study is that "Surface modified
indigenously
designed and produced titanium dental implant system with hybrid threads and
anti-rotational features demonstrate clinically relevant implant success rate." |