| CTRI Number |
CTRI/2025/11/097170 [Registered on: 11/11/2025] Trial Registered Prospectively |
| Last Modified On: |
09/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
implant placement using Lab made versus digital guide. |
|
Scientific Title of Study
|
Evaluation and Comparison of Accuracy of Placement of Implants with Surgical Template versus Surgical Guide- A Clinico – Radiographic 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 Rahul Bhardwaj |
| Designation |
Post graduate Student |
| Affiliation |
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana |
| Address |
Room no 11, block b, SGT Dental College Hospital and Research Institute, SGT University, Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India.
Gurgaon HARYANA 122505 India |
| Phone |
9811398418 |
| Fax |
|
| Email |
210498rahul@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Amit Bhardwaj |
| Designation |
Professor and Director, Ph.D programmes |
| Affiliation |
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana |
| Address |
Room no 11, block b SGT Dental College Hospital and Research
Institute, SGT University, Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India.
Gurgaon HARYANA 122505 India |
| Phone |
9818718872 |
| Fax |
|
| Email |
amit.bhardwaj@sgtuniversity.org |
|
Details of Contact Person Public Query
|
| Name |
Dr Amit Bhardwaj |
| Designation |
Professor and Director, Ph.D programmes |
| Affiliation |
SGT Dental College Hospital and Research Institute, SGT University, Gurugram Haryana |
| Address |
Room no 11, block b SGT Dental College Hospital and Research
Institute, SGT University, Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India.
Gurgaon HARYANA 122505 India |
| Phone |
9818718872 |
| Fax |
|
| Email |
amit.bhardwaj@sgtuniversity.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
SGT DENTAL COLLEGE HOSPITAL AND RESEARCH INSTITUTE |
| Address |
Room no 11, block b SGT Dental College Hospital and Research
Institute, SGT University,Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India. |
| 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 rahul Bhardwaj |
SGT Dental College, Hospital and Research Institute |
Room no 11, block b, SGT Dental College Hospital and Research Institute, SGT University, Budhera, Gurugram-Badli Road, Gurugram- 122505, Haryana, India. Gurgaon HARYANA |
9811398418
210498rahul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee- SGT Dental College , Hospital and Research Institute (IEC-SGTDCHRI) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Presence of edentulous site indicated for dental
implants |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
25.00 Day(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in the age group of 25-60 years inclusive of both genders.
2.Single or multiple missing tooth space.
3.Favourable oral hygiene in the examination visit.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The accuracy of implant placement with surgical template will be inferior to that with the
surgical guide. Also, less time consumption and better soft tissue healing will be expected with
surgical guide compared to surgical template. |
July 2025-Collection of Materials
1st August 2025-Enrolment of the Patients (14)
November 2025-Follow up of 1st 14 Patient
31st January 2026- Enrolment of the Patients (14)
April 2026-Follow up of 2nd 14 Patients
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
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)
|
01/01/2026 |
| 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="6" Days="10" |
|
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 - NO
|
|
Brief Summary
|
The study titled "Evaluation and Comparison of Accuracy of Placement of Implants with Surgical Template versus Surgical Guide: A Clinico–Radiographic Study" aims to assess and compare the precision of dental implant placement using surgical templates and surgical guides. It includes 28 implant sites divided into two groups. Accuracy is evaluated using pre- and post-operative CBCT scans, measuring linear and angular deviations. The study also considers patient comfort using a VAS questionnaire. The investigation addresses the lack of comparative studies between these techniques and seeks to establish which method offers superior accuracy and patient outcomes. |