| CTRI Number |
CTRI/2025/12/098346 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
03/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
How accurate is digitally guided dental implant placement immediately after tooth extraction? |
|
Scientific Title of Study
|
Accuracy of guided implant surgery in immediate vs delayed implant placement: An in vivo study |
| 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 Anuj Chandak |
| Designation |
Reader |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre
Digdoh hills Hingna Road, Nagpur 440019
Digdoh hills Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158192345 |
| Fax |
|
| Email |
dr.anujchandak@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anuj Chandak |
| Designation |
Reader |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre
Digdoh hills Hingna Road, Nagpur 440019
Digdoh hills Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158192345 |
| Fax |
|
| Email |
dr.anujchandak@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anuj Chandak |
| Designation |
Reader |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
Ranjeet Deshmukh Dental College and Research Centre
Digdoh hills Hingna Road, Nagpur 440019
Digdoh hills Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158192345 |
| Fax |
|
| Email |
dr.anujchandak@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ranjeet Deshmukh Dental College and research centre, Digdoh Hills Hingna road, Nagpur 440019 |
|
|
Primary Sponsor
|
| Name |
Dr Anuj Chandak |
| Address |
205 Dept Of Prosthodontics Ranjeet Deshmukh Dental College and research Centre Digdoh hills Hingana Road Nagpur 440019 |
| Type of Sponsor |
Private medical college |
|
|
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 Anuj Chandak |
Ranjeet Deshmukh dental College |
room no 205, Department of prosthodontics Digdoh hills Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA |
9158192345
dr.anujchandak@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Vspm Dental college and research center Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Guided Implant Surgery |
Dental implant placement by use of Surgical guide in immediate and delayed type of cases Prosthesis will be given after 3-6 months |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. For Group A: Patients with tooth without any active periapical infection which is indicated for extraction and bounded anteriorly and posteriorly by teeth.
2. Group B: Partially edentulous adults with missing teeth bounded anteriorly and posteriorly by teeth.
3. An expected sufficient bone volume to perform implant insertion with at least a 3.3mm implant.
4. Stable medical condition to undergo implant surgery (ASA 1 or 2)
|
|
| ExclusionCriteria |
| Details |
1. Patients unwilling to participate in the study
2. Presence of active periapical infection for immediate implant placement group
3. Systemic disorders generally prohibiting implant therapy
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Angular and linear deviation between planned and executed Guided implant surgery |
3-6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 4 |
|
Date of First Enrollment (India)
|
15/12/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Poorly placed implants may violate vital anatomic structure, are
associated with increased marginal bone loss are more difficult to restore and
influence the restoration emergence and appearance. Therefore, any clinician practicing implant dentistry should follow an
accurate approach for ideal implant placement. Implant placement in a postextraction site in an ideal position is a
challenge for clinicians, complications because of misangulation can be
devastating. Surgical guides are frequently used to control all the steps of implant
placement surgery, including drilling location and angulations, and final
implant location. Subsequently, they are necessary tools in the hands of novice
clinicians. Although the efficacy of surgical guides has been proven clinically
majority of the research has tested it in conventional implant placement
however immediate implant placement remains to be investigated. Therefore, the present study was planned to evaluate the effect of
timing of implant placement on the accuracy of guided implant placement. |