| CTRI Number |
CTRI/2026/01/101157 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
ASSESSING THE IMPACT OF DIFFERENT POST EXTRACTION INSTRUCTION DELIVERY APPROACHES ON PATIENT UNDERSTANDING AND COMPLIANCE. |
|
Scientific Title of Study
|
A RANDOMIZED CONTROLLED TRIAL ASSESSING THE IMPACT OF DIFFERENT POST EXTRACTION INSTRUCTION DELIVERY APPROACHES ON PATIENT UNDERSTANDING AND COMPLIANCE |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tanushri Jibhakate |
| Designation |
Intern |
| Affiliation |
|
| Address |
02 Department Of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
7887569858 |
| Fax |
|
| Email |
tanushrijibhakate05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pranav Ingole |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
02 Department Of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822573499 |
| Fax |
|
| Email |
pranavingole05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pranav Ingole |
| Designation |
Associate Professor |
| Affiliation |
|
| Address |
02 Department Of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822573499 |
| Fax |
|
| Email |
pranavingole05@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur |
| Address |
02 Department of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Pranav Ingole |
Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur |
02 Department of Oral and Maxillofacial Surgery Ranjeet Deshmukh Dental College and Research Centre Digdoh Hills Hingna Nagpur
Nagpur
MAHARASHTRA |
9822573499
pranavingole05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patient Indicated Undergoing Simple Dental Extractions
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Verbal and video instruction
|
Patient are Given Verbal and video based instructions and the Assessment is done on the Basis of answers of the Questionare
|
| Intervention |
Verbal and Written instructions
|
Patient are Given Verbal and Written Instructions and the Assessment is done on Basis of answers of the Questionare |
| Comparator Agent |
Verbal explanation only
|
Patient are Given Verbal Instructions And the Assessment Is done On the Basis of Answers Of the questionare |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Adults aged 18 to 65 undergoing simple dental extractions
2 Able to provide informed consent
3 Patients who has not undergone extraction previously |
|
| ExclusionCriteria |
| Details |
1 Cognitive impairments or communication barriers
2 Multiple extractions or surgical extractions
3 Previous participation in similar studies
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of level of understanding of patient through a questionnaire
|
Level of understanding of patient through a questionnaire is assessed after 7 days during follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Compliance via follow-up evaluation of wound healing ,adherence to dietary & hygiene instructions
|
Patient is assessed about compliance via follow up evaluation about wound healing adherence to dietary & hygiene instructions on day 7 |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/02/2026 |
| 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 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 study is a randomized controlled trial conducted to compare the effectiveness of different post-extraction instruction delivery methods on patient understanding and compliance. Ninety patients undergoing simple tooth extraction are divided into three groups receiving verbal instructions alone, verbal plus written instructions, or verbal plus audiovisual instructions. Patient understanding, compliance, and satisfaction are assessed using questionnaires and follow-up evaluations. The study aims to identify the most effective method to improve postoperative care and reduce complications.
|