| CTRI Number |
CTRI/2025/10/095700 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
07/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing The Accuracy of Dental Implant Placement Using Different Drilling Technique with and without Computer-Guided Placement |
|
Scientific Title of Study
|
Comparative Evaluation of Positional Accuracy of Dental Implants Placed using Piezoelectric Osteotomy with and without use of Dynamic Navigation - A Randomised Controlled 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 Vasireddy Sri Naga Praharshitha |
| Designation |
Post Graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
PG Clinic 8, First Floor, Block 2, Department of Prosthodontics, Vishnu Dental College, Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8121484383 |
| Fax |
|
| Email |
praharshithavasireddy123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D.Bheemalingeswara Rao |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
PG Clinic 8 Block 2 Department of Prosthodontics Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8121484383 |
| Fax |
|
| Email |
bheemalingeswararao.d@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vasireddy Sri Naga Praharshitha |
| Designation |
Post Graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
PG Clinic 8 Block 2 Department of Prosthodontics Vishnu Dental College Vishnupur Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8121484383 |
| Fax |
|
| Email |
praharshithavasireddy123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College Vishnupur Bhimavaram West Godavari District Andhra Pradesh India 534202 |
|
|
Primary Sponsor
|
| Name |
Dr.Vasireddy Sri Naga Praharshitha |
| Address |
PG Clinic 8 Block 2 Department of Prosthodontics Vishnu Dental College Vishnupur Bhimavaram |
| 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 Vasireddy Sri Naga Praharshitha |
Vishnu Dental College |
Pg Clinic room number 8 Department of Prosthodontics Block 2, Floor 1, Vishnu Dental College, Vishnupur, Bhimavaram, West Godavari, Andhra Pradesh, India
West Godavari
ANDHRA PRADESH |
8121484383
praharshithavasireddy123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Method |
Positional accuracy will be assessed in degree of angular deviation using Navident software immediately after implant placement at day zero. |
| Intervention |
Dynamic Navigation |
Positional accuracy will be assessed in degree of angular deviation using navident software immediately after implant placement at day zero by using Dynamic Navigation. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age between 20-60 years.
2. Missing anterior teeth and premolars.
3. ASA I
4. Patients willing to comply with the study. |
|
| ExclusionCriteria |
| Details |
1. Limited mouth opening
2. Teeth with Active infections or inflammations.
3. Poor comprehense to oral hygiene and Chronic smokers.
4. ASA II, III, IV, V
5. Patients subjected to radiotherapy to head and neck. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Positional Accuracy |
Baseline and Day Zero |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Primary Stability
Insertion Torque |
Baseline and Day Zero |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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)
|
20/10/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 methodology involves informed consent from the patient followed Diagnostic impressions and models Surface scans will be taken in STL format and preoperative CBCT will be obtained to generate DICOM files. The DICOM and STL files will be merged, and implant planning will be carried out using specialized software. The total sample size will be 32, divided into two groups of 16 each. Group 1 will undergo implant placement using the freehand technique, while Group 2 will undergo implant placement with dynamic navigation. In Group 1, a supracrestal incision will be given, followed by elevation of a full-thickness mucoperiosteal flap, and implant placement will be performed freehand. In Group 2, a drill tag will be attached to the drill, and a jaw tag will be attached to the stent in the patient’s mouth, followed by calibration of the tooth in the same arch and opposing arch before implant placement using dynamic navigation. Postoperative CBCT will be obtained for both groups, with Group 1 using Implant Studio software and Group 2 using Navident software. positional accuracy is measured as primary outcome at baseline and day zero and primary stability insertion torque as secondary outcomes will be measured. |