| CTRI Number |
CTRI/2026/01/100965 [Registered on: 13/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two dental implant system. |
|
Scientific Title of Study
|
Comparative evaluation of implant stability, clinical and CBCT outcomes of two different implant systems in partially edentulous patients- a randomized clinical trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dhanshri Bawa |
| Designation |
Post graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02 Department of
Periodontology,
SMBT Dental
College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9867888827 |
| Fax |
|
| Email |
dhanashribawa01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Purushottam Rakhewar |
| Designation |
Head of Department and PG Guide |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02 Department of
Periodontology,
SMBT Dental
College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9370017343 |
| Fax |
|
| Email |
drpsrakhewar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhanshri Bawa |
| Designation |
Post graduate student |
| Affiliation |
SMBT Dental College and Hospital |
| Address |
G-02 Department of
Periodontology,
SMBT Dental
College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA
422608
India |
| Phone |
9867888827 |
| Fax |
|
| Email |
dhanashribawa01@gmail.com |
|
|
Source of Monetary or Material Support
|
| SMBT Dental College and Hospital, Sangamner, Ahmednagar, Maharashtra, India, 422608 |
|
|
Primary Sponsor
|
| Name |
Dr Dhanshri Bawa |
| Address |
G-02 Department of
Periodontology,
SMBT Dental College and Hospital, Ghulewadi , Sangamner, Ahmednagar, Maharashtra, India, 422608 |
| 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 Dhanshri Bawa |
SMBT Dental College and Hospital, Sangamner |
G-02 Department of
Periodontology,
SMBT Dental
College and Hospital, Sangamner
Ahmadnagar
MAHARASHTRA |
9867888827
dhanashribawa01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Committee on Ethics, SMBT Dental college , sangamner |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adin Implant System |
Following the administration of local anaesthesia, a horizontal crestal incision will be made, and mucoperiosteal flaps will be reflected, with careful attention to preserving as much interproximal soft tissue as possible. Sequential osteotomy will be carried out, and a suitably sized ADIN implant body will be placed using a ratchet.
The implant will be covered with a cover screw. The mucoperiosteal flaps will be
repositioned and secured using non-absorbable black silk surgical sutures. Interrupted sutures will be placed to ensure closure.
Surgery will be performed at 2 stages :
Stage 1 – implant body will be placed covered by cover screw.
Stage 2 – cover screw will be detached and healing abutment will be positioned (4 months after stage 1 surgery) 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared.
All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery.
To assess the implant stability, clinical and CBCT changes and the resultant outcome after placement of ADIN implant at baseline, stage 2, during loading and 1 year follow up clinically, at baseline and 1 year follow up CBCT. |
| Comparator Agent |
Implantswiss Implant System |
Following the administration of local anaesthesia, a horizontal crestal incision will be made, and mucoperiosteal flaps will be reflected, with careful attention to preserving as much interproximal soft tissue as possible. Sequential osteotomy will be carried out, and a suitably sized Implantswiss implant body will be placed using a ratchet. The implant will be covered with a cover screw. The mucoperiosteal flaps will be repositioned and secured using non-absorbable black silk surgical sutures. Interrupted sutures will be placed to ensure closure. Surgery will be performed at 2 stages: Stage 1 – implant body will be placed covered by cover screw. Stage 2 – cover screw will be detached and healing abutment will be positioned (4 months after stage 1 surgery) 1 month after stage 2 surgery impression will be taken for crown prosthesis and crown will be delivered soon after it is prepared. All implants placement will be done by single trained surgeon at stage 1 and stage 2 surgery. To assess the implant stability, clinical and CBCT changes and the resultant outcome after placement of Implantswiss implant at baseline, stage 2, during loading and 1 year follow up clinically, at baseline and 1 year follow up CBCT. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age group 18 years or older, with the capacity to comprehend and able to sign a written informed consent form.
Partially edentulous patient requiring 1 or more single implant supported crown.
Patient willing for surgery. |
|
| ExclusionCriteria |
| Details |
General contraindications to implant surgery.
Local and systemic conditions affecting bone .
Any local anatomical limitations.
Poor oral hygiene and motivation.
Presence of untreated periodontitis or active acute/purulent infection localized to the site proposed for implant placement.
Unwilling or unable to adhere to commit to 1-year follow-up.
Treated or currently undergoing treatment with intravenous amino-bisphosphonates.
Absence of antagonistic occlusal surfaces for the study implants at implant loading.
Implant site requiring major procedures including sinus lift with lateral approach, minor augmentation procedures such as crestal sinus lift. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Successful osseointegration
stable, functional, and long term replacement of missing tooth |
Baseline
At stage 2 surgery
during loading
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
02/02/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dhanashribawa01@gmail.com].
- For how long will this data be available start date provided 15-05-2026 and end date provided 15-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The study aims to generate
comparative data on the implant stability, clinical and CBCT outcomes of ADIN
and IMPLANTSWISS implant systems in partially edentulous patients. The expected
outcomes include evaluating implant stability, marginal bone changes and
clinical effectiveness over a 1-year follow-up period. This information will
help determine the relative success and reliability of both implant systems,
offering evidence to guide clinical decision-making in implant dentistry. |