| CTRI Number |
CTRI/2025/12/099743 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
22/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Finding the change in positioning of dental implants with different digital orientation device. |
|
Scientific Title of Study
|
Comparison of accuracy and precision of open and closed sleeve implant surgical guide with pre surgical implant planning 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 |
varshavathi |
| Designation |
Post graduate |
| Affiliation |
Sri Ramachandra Dental College, Sri Ramachandra Institute of Higher Education and Research. |
| Address |
Department of Prosthodontics, crown and bridge
Implantology
Room No : 08
Sri Ramachandra Dental College,
Sri Ramachandra Institute of Higher Education and Research,
Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
9003987600 |
| Fax |
|
| Email |
varshathark@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Anand Kumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Dental College, Sri Ramachandra Institute of Higher Education and Research. |
| Address |
Department of Prosthodontics, crown and bridge.
Implantology
Room No : 08
Sri Ramachandra Dental College,
Sri Ramachandra Institute of Higher Education and Research,
Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
9444121616 |
| Fax |
|
| Email |
anand_anandhi@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Anand Kumar |
| Designation |
Professor |
| Affiliation |
Sri Ramachandra Dental College, Sri Ramachandra Institute of Higher Education and Research. |
| Address |
Department of Prosthodontics, crown and bridge.
Implantology
Room No : 08
Sri Ramachandra Dental College,
Sri Ramachandra Institute of Higher Education and Research,
Porur.
Chennai
TAMIL NADU
600116
India |
| Phone |
9444121616 |
| Fax |
|
| Email |
anand_anandhi@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Porsthodontics, crown and bridge,
Implantology
Room No. 8
Sri Ramachandra Dental college,
Sri Ramachandra Institute of Higher Education and Research.
Porur,
Chennai - 600116. |
|
|
Primary Sponsor
|
| Name |
Varshavathi |
| Address |
6B/1 srinivasan street
pudupalayam
cuddalore - 607001
tamil nadu |
| 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 Varshavathi |
Sri Ramachnadra Institute of Higher Education and Research |
Department of Prosthodontics, crown and bridge,
Implantology
Room No. 08.
Chennai
TAMIL NADU |
9003987600
varshathark@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient having missing unilateral mandibular posteriors |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Closed sleeves surgical guide |
3.5mm width and 5mm height cyclinder size encircling the complete implant drilling site. |
| Intervention |
Open sleeve surgical guides |
3.5mm width and 5mm height cyclinder with an offset opening in the buccal aspect of the implant drilling site. This is used in cases for easy insertion osteotomy drill. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Unilateral mandibular missing premolars and molars. |
|
| ExclusionCriteria |
| Details |
Severe acute or chronic periodontitis
History of radiotherapy and chemotherapy
History of Diabetes and bleeding disorders
Clinical or radiographic peri apical pathology
Physiological or psychiatric problem
Drug abuse
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the corono-apical, h0rizontal and depth deviation comparing the pre-operative implant planning. |
Post implant placement - Day 1 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the hard-tissue changes due to surgical variation during osseointegrative phase of 0, 30, 60 & 90 days.
|
Peri apical radiograph taken on day 0, day 30, day 60, day 90 |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
06/01/2026 |
| 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="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
|
Guided sleeves - precise control over the angulation, depth, aligning surgical execution with pre-operative virtual planning. There are two types of sleeves, closed and open sleeves. Closed sleeve - maintaining the angulation and depth of the drill and enhanced precision and control during the drilling process. Though closed sleeve achieves accuracy and precision, it has certain limitations like difficulty in using in the posteriors, the circular tube blocks the field of surgery and it also hampers saline irrigation. To, overcome this limitations, open sleeve guides are used. This study is compare the precision and accuracy of open sleeve and closed sleeves. |