| CTRI Number |
CTRI/2026/01/102604 [Registered on: 30/01/2026] Trial Registered Prospectively |
| Last Modified On: |
18/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation Of Efficacy Of Periotome Assisted Extraction Versus Conventional Forceps In Single Rooted Primary Teeth: A randomized controlled study |
|
Scientific Title of Study
|
Comparative Evaluation Of Efficacy Of Periotome Assisted Extraction Versus Conventional Forceps In Single Rooted Primary Teeth: A randomized controlled 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 Hinal Kanabar |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Pacific Dental College And Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
09265289652 |
| Fax |
|
| Email |
heenalkanabar123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DINESH RAO |
| Designation |
HOD PG guide |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Pacific Dental College And Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
09265289652 |
| Fax |
|
| Email |
pedodinesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrHinal Kanabar |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital |
| Address |
Pacific Dental College And Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
09265289652 |
| Fax |
|
| Email |
heenalkanabar123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Dental College And Hospital Debari Udaipur 313024 |
|
|
Primary Sponsor
|
| Name |
Hinal Kanabar |
| Address |
Pacific Dental College And Hospital Debari Udaipur 313024 |
| 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 |
| DrHinal Kanabar |
Pacific Dental College And Hospital Debari Udaipur 313024 |
Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College and Hospital Debari Udaipur 313024 Rajasthan
Udaipur
RAJASTHAN |
09265289652
heenalkanabar123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee Sai Tirupati University Udaipur Rajasthan India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional forceps |
Extraction of single rooted primary teeth under local anesthesia |
| Intervention |
Periotome assisted extraction |
Extraction of single rooted primary teeth under local anesthesia |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 4 to 10 years requiring extraction of non restorable or over retained single rooted primary teeth
Cooperative or minimally anxious children Frankl ratings 3 or 4 |
|
| ExclusionCriteria |
| Details |
Special healthcare needs children
Frankl behavior rating 1 or 2 |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Periotome assisted extraction minimizes trauma
compared to conventional forceps |
Evaluation will be done at the baseline and 24 hours recall |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Periotome assisted extraction shows less pain, faster healing, and fewer complications compared to conventional forceps |
Evaluation will be done at the baseline and 24 hours recall |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
16/02/2026 |
| 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
|
The study focuses on atraumatic extraction techniques in pediatric dentistry, emphasizing the importance of preserving socket integrity and minimizing tissue injury during primary tooth removal. The periotome, a specialized instrument designed to sever periodontal ligament (PDL) fibers, enables gentle luxation of the tooth, resulting in reduced trauma compared to conventional forceps.
The research aimed to compare periotome-assisted extraction with traditional forceps extraction in single-rooted primary teeth by evaluating procedure duration, pain levels (using WBFS and SEM scales), soft-tissue trauma, and postoperative analgesic needs. Findings suggest that the periotome significantly reduces pain, soft-tissue injury, and postoperative discomfort while improving clinical efficiency.
Overall, the technique proves to be a superior, child-friendly alternative that enhances patient comfort and promotes faster healing, making it highly suitable for pediatric dental practice. |