| CTRI Number |
CTRI/2026/04/107234 [Registered on: 01/04/2026] Trial Registered Prospectively |
| Last Modified On: |
30/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing the accuracy of CAD-CAM (computer aided design computer aided manufacturing) printed surgical guide vs a conventional thermoplastic surgical guide using cone beam computed tomography- An in vivo study |
|
Scientific Title of Study
|
Comparing the accuracy of CAD-CAM (computer aided design computer aided manufacturing) printed surgical guide vs a conventional thermoplastic surgical guide using cone beam computed tomography (CBCT)- An in vivo study |
| 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 Hritika Gawande |
| Designation |
MDS student |
| Affiliation |
Government college of dentistry indore |
| Address |
room no 7 Dept of Prosthodontics Govt College of dentistry Indore 452001
Indore
MADHYA PRADESH
452001
India |
| Phone |
09754941964 |
| Fax |
|
| Email |
gawandehritika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Harsh Chansoria |
| Designation |
Associate Professor |
| Affiliation |
Government college of dentistry indore |
| Address |
room no 7 Dept of Prosthodontics Govt College of Dentistry Indore 452001
Indore
MADHYA PRADESH
452001
India |
| Phone |
9425016952 |
| Fax |
|
| Email |
harsh.chansoria@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hritika Gawande |
| Designation |
MDS student |
| Affiliation |
Government college of dentistry indore |
| Address |
Room no 7 Dept of Prosthodontics Govt College of Dentistry Indore
Indore
MADHYA PRADESH
452001
India |
| Phone |
9754941964 |
| Fax |
|
| Email |
gawandehritika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. College of Dentistry, indore |
|
|
Primary Sponsor
|
| Name |
Dr hritika gawande |
| Address |
Govt college of dentistry indore Madhya Pradesh 452001 |
| Type of Sponsor |
Other [Self] |
|
|
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 Hritika Gawande |
Govt. College of Dentistry, indore |
Govt college of dentistry, indore Madhya Pradesh 452001
Indore
MADHYA PRADESH |
09754941964
gawandehritika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD CAM guide |
accuracy of cad cam milled thermoplastic guide will be compared to a conventional thermoplastic guide |
| Comparator Agent |
thermoplastic guide |
Cad Cam milled implant guide will be compared to a conventionalthermoplastic surgical guide |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patients (18 years and above).
2. Systemically and periodontally healthy.
3. Edentulous sites with intact adjacent teeth in maxillary anterior and premolar region.
4. Patients consenting for cone beam computed tomography (CBCT) scanning as part of treatment planning
|
|
| ExclusionCriteria |
| Details |
• The presence of active periodontal disease and medical conditions that are contraindicated for implant therapy |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the key referecnce article used for sample collection stated that positional accuracy of CAD CAM printed guide was more than conventional thermoplastic guide. |
the time period is 7 days, comparing the outcome to the planned position of implant. |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/04/2026 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [gawandehritika@gmail.com].
- For how long will this data be available start date provided 31-12-2027 and end date provided 01-01-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The aim of this study is to compare the accuracy of implant placement using CAD CAM printed surgical guide and a conventional thermoplastic surgical guide using cone beam computed tomography. The objective is: · To determine the dimensional deviations in the planned and placed implant position using a conventional thermoplastic surgical guide. · To determine the dimensional deviations in the planned and placed implant position using a 3D CAD-CAM printed guide template. To compare the accuracy of implant placement by a conventional thermoplastic surgical guide to a CAD-CAM printed surgical guide using cone beam computed tomography |