| CTRI Number |
CTRI/2026/02/104531 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
In patients who need dental implants, does placing implants using computer guidance compared to the traditional manual method give better accuracy and stability |
|
Scientific Title of Study
|
Evaluation of implant placement accuracy and stability using conventional and computer-guided technique. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Karri Lakshmi Prasanna |
| Designation |
Post graduation, 1st MDS |
| Affiliation |
SIBAR Institute Of Dental Sciences |
| Address |
Room No:3,Department of Oral and Maxillofacial surgery,PG Block SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522009
India |
| Phone |
9494547789 |
| Fax |
|
| Email |
karrilakshmiprasanna237@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr L Krishna Prasad |
| Designation |
Professor And Head of The Department |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Room No:3,Department of Oral and Maxillofacial Surgery, PG Block SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
Guntur
ANDHRA PRADESH
522009
India |
| Phone |
9848123244 |
| Fax |
|
| Email |
dr_lkp@sids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr L Krishna Prasad |
| Designation |
Professor And Head of The Department |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Room No:3, Department of Oral and Maxillofaial Surgery,PG block, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur
ANDHRA PRADESH
522009
India |
| Phone |
9848123244 |
| Fax |
|
| Email |
dr_lkp@sids.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Karri Lakshmi Prasanna |
| Address |
Room No:3,SIBAR INSTITUTE OF DENTAL SCIENCES Takkellapadu, Guntur. Pincode: 522009 |
| 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 |
| Karri lakshmi Prasanna |
SIBAR Institute Of Dental Sciences |
Room No:3, Department of Oral and maxillofacial Surgery,PG block, SIBAR Institute Of Dental Sciences, Takkellapadu, Guntur-522509
Guntur
ANDHRA PRADESH |
9494547789
karrilakshmiprasanna237@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sibar Institute of Dental Sciences |
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 |
Computer guided implant placement using 3D printed surgical gide |
Flapless implant placement will be performed after evaluation of the available bone height and width. A tissue punch will be used initially to facilitate access, followed by sequential osteotomy preparation with the assistance of a 3D-printed surgical guide. The dental implant will then be placed in the prepared site |
| Comparator Agent |
Conventional implant placement |
Flapless implant placement will be performed after evaluation of the available bone height and width. A tissue punch will be used initially to facilitate access, followed by sequential osteotomy preparation performed freehand according to standard clinical protocol. The dental implant will then be placed in the prepared site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 18–65 years with partial edentulism requiring dental implants.
2. D2 & D3 type of bone.
3. Patients falling under ASA I or II.
4. Patients providing informed consent and willing for follow-up.
|
|
| ExclusionCriteria |
| Details |
1. History of head-and-neck radiotherapy or chemotherapy.
2. Habitual smokers or substance abuse.
3. Pregnant or lactating women.
4. Patients with severe atrophic ridges.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical outcome-Implant Stability
Radiological outcome – Implant Placement Accuracy
Marginal Bone Loss
|
Immediate post op, 3 month and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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)
|
20/03/2026 |
| 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="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
|
| This study aims to evaluate and compare the accuracy of implant placement and stability of dental implants placed using the conventional freehand technique and the computer-guided 3D printed surgical Guide. Dental implant success largely depends on precise positioning and adequate stability at the time of placement. While the conventional method relies on the surgeon’s clinical judgment, the computer-guided approach uses three-dimensional imaging and surgical guides to enhance precision. A sample size of 18 Participants requiring dental implant placement will be randomly assigned to either the conventional or computer-guided group. The implant position accuracy and primary stability will be assessed and compared between the two techniques. The findings of this study may help determine the more predictable and efficient method for implant placement, thereby improving clinical outcomes and patient safety. | |