| CTRI Number |
CTRI/2025/08/093893 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
31/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [IMPLANT] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study to find out which way is better for placing dental implants, with a guide or by hand. |
|
Scientific Title of Study
|
Comparative evaluation of the accuracy of single implant placement using static pilot guide versus freehand technique through CBCT-A randomized clinical study |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Akhrienuo Kiso |
| Designation |
Post graduate student |
| Affiliation |
Government dental college and hospital,Mumbai |
| Address |
215, DEPARTMENT OF PERIODONTOLOGY , GOVERNMENT DENTAL COLLEGE AND HOSPITAL, ST. GEORGE HOSPITAL CAMPUS
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9089368118 |
| Fax |
|
| Email |
akhrienuo1450@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
PROFFESOR (ACADEMIC) |
| Affiliation |
Government dental college and hospital, Mumbai |
| Address |
215, DEPARTMENT OF PERIODONTOLOGY , GOVERNMENT DENTAL COLLEGE AND HOSPITAL, ST. GEORGE HOSPITAL CAMPUS
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
PROFFESOR (ACADEMIC) |
| Affiliation |
Government dental college and hospital, Mumbai |
| Address |
215, DEPARTMENT OF PERIODONTOLOGY , GOVERNMENT DENTAL COLLEGE AND HOSPITAL, ST. GEORGE HOSPITAL CAMPUS
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Room 215, Dept. of Periodontology, Government Dental College and Hospital, Mumbai, Fort, PD Mello road, Maharashtra, 400001 |
|
|
Primary Sponsor
|
| Name |
Dr Akhrienuo Kiso |
| Address |
215, DEPARTMENT OF PERIODONTOLOGY, GOVERNMENT DENTAL COLLEGE AND HOSPITAL, ST GEORGE HOSPITAL CAMPUS |
| Type of Sponsor |
Other [SELF SPONSERED] |
|
|
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 AKHRIENUO KISO |
GOVERNMENT DENTAL COLLEGE AND HOSPITAL, MUMBAI |
215, DEPARTMENT OF PERIODONTOLOGY , GOVERNMENT DENTAL COLLEGE AND HOSPITAL, ST. GEORGE HOSPITAL COMPOUND ,
Mumbai
MAHARASHTRA |
9089368118
akhrienuo1450@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GOVERNMENT DENTAL COLLEGE AND HOSPITAL,MUMBAI |
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 |
freehand implant placement |
freehand implant placement of single missing tooth based on pre-surgical CBCT implant placement planning ,day 1, implant placement and after 2 weeks, postsurgical implant position CBCT Edit || Delete
|
| Intervention |
static pilot guide |
Static pilot guide used for the initial pilot drill for single missing tooth implant placement based on pre-surgical CBCT implant placement planning
,day 1, implant placement and
after 2 weeks, postsurgical implant position CBCT |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy patients (21-65 years) and/or patients with systemic conditions (example- diabetes and/or hypertension) which is under control and opting dental implants for replacement of single missing teeth.
2. Good oral hygiene and periodontal status; having a score of 0-2 in the gingival index
and a score of 0-2 in the plaque index.
3. Adequate amount of bone volume and adequate density at implant site allowing to
perform the surgery.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic diseases that contraindicates the surgery; immune
compromised patients.
2. Patients with mouth opening of fewer than three fingers, which might pose a
problem to the placement of a surgical guide.
3. Patients with missing teeth at the free end.
4. Patients not willing to participate in the study |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy of implant placement by using static pilot guide versus freehand in single tooth implants through CBCT evaluation. |
Day 1 (CBCT before surgery for implant placement planning)
2 weeks(CBCT after implant placement) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. To evaluate the angular deviation measured in degrees.
b. To evaluate implant platform deviation measured in degrees.
c. To evaluate deviation at implant apex measured in millimeter.
d. To evaluate depth deviation in millimeter.
e. To compare accuracy and efficiency between planned and placed implants using static pilot guide versus freehand in maxillary versus mandibular single tooth implants. |
Day 1 (CBCT before surgery for implant placement planning)
2 weeks(CBCT after implant placement) |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/09/2025 |
| 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="1"
Months="6"
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 - NO
|
|
Brief Summary
|
This randomized controlled trial compares the accuracy of single-tooth implant placement using a static pilot guide versus freehand technique. Thirty-two patients are randomly assigned to two groups, with equal maxillary and mandibular distribution. The test group uses a pilot-guided drill; the control group uses a freehand approach. Pre- and post-operative CBCT scans assess placement accuracy. Key metrics include angular, platform, apex, and depth deviations, along with efficiency across arches. The study aims to determine whether pilot guides improve precision in implantology. |