| CTRI Number |
CTRI/2025/10/095982 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
10/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparision of positional accuracy in placing Dental Implants using two differnt drilling methods with the help of a Computer Guided System |
|
Scientific Title of Study
|
Comparative Evaluation of Positional Accuracy of Dental Implants Placed with Conventional Drill Osteotomy and Piezoelectric Osteotomy using Dynamic Navigation System |
| 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 P Ambica |
| Designation |
Post Graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Pg Clinic room no: 8, Department of Prosthodontics, Block 2, First floor, Vishnu Dental College,Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8309308427 |
| Fax |
|
| Email |
ambica.putti@vdc.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Narasimha Rao |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Pg Clinic room no: 8, Department of Prosthodontics, Block 2, First floor, Vishnu Dental College,Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9491715620 |
| Fax |
|
| Email |
narasimhag@vdc.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Narasimha Rao |
| Designation |
Associate Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Pg Clinic room no: 8, Department of Prosthodontics, Block 2, First floor, Vishnu Dental College,Vishnupur,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9491715620 |
| Fax |
|
| Email |
narasimhag@vdc.edu.in |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,Vishnupur,Bhimavaram,
West Godavari,AndhraPradesh,India 534202 |
|
|
Primary Sponsor
|
| Name |
Dr P Ambica |
| Address |
Vishnu Dental College,Sri Vishnu Educational Society,Bhimavaram,west Godavari,Andhra Pradesh, India 534202 |
| 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 P Ambica |
Vishnu Dental College |
Pg Clinic room no: 8, Department of Prosthodontics, Block 2, First floor, Vishnu Dental College,Vishnupur,Bhimavaram,534202, Andhra Pradesh, India
West Godavari
ANDHRA PRADESH |
08309308427
ambica.putti@vdc.edu.in |
|
|
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: K082||Atrophy of edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional drill osteotomy |
Implant osteotomy site preparation using conventional implant drills for 20 to 30 minutes followed by implant placement and assesing positional accuracy using Evalunav software immediately on Day Zero |
| Intervention |
Piezo Electric Osteotomy |
Implant osteotomy site preparation using piezo electric tips for 30 to 45 minutes followed by implant placement and positional accuracy assessment using evalunav software immediately on day Zero |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age between 20-60 years.
Missing anterior teeth and premolars
ASA I
Patients willing to comply with the study |
|
| ExclusionCriteria |
| Details |
Limited mouth opening
Teeth with active infections or inflammations
Poor comprehense to oral hygiene and Chronic smokers.
ASA II,III,IV,V
Patients subjected to radiotherapy of 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 |
Base line and Day zero |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Primary stability
Insertion Torque |
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)
|
22/10/2025 |
| 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) |
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 methodology involves obtaining Institutional Review Board approval followed by informed consent from the patient. Diagnostic impressions will be made, and models will be prepared. 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 conventional drill osteotomy using Dynamic navigation system, while Group 2 will undergo piezo electric osteotomy using dynamic navigation system. In Group 1, a supracrestal incision will be given, followed by elevation of a full-thickness mucoperiosteal flap, and implant placement will be performed with conventional drills using Dynamic Navigation system. In Group 2 a supracrestal incision incision will be given,followed by elevation of full thickness mucoperiosteal flap,and implant placement with piezo electric tips using Dynamic Navigation system. Postoperative CBCT will be obtained for both groups, and positional accuracy is compared using Evalunav software. |