| CTRI Number |
CTRI/2025/12/099115 [Registered on: 15/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Extraction of teeth using Twisted Elevators in Paediatric Patients |
|
Scientific Title of Study
|
Comparative evaluation of the effectiveness of straight elevator v/s twisted elevator in children during extraction of primary grossly decayed teeth and root stumps. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal Audichya |
| Designation |
Post graduate student |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
7597172818 |
| Fax |
|
| Email |
kunalaudichya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Audichya |
| Designation |
Post graduate student |
| Affiliation |
Pacific dental college and hospital |
| Address |
Pediatric department, room number 9, Pacific dental college and hospital, Debari, Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
7597172818 |
| Fax |
|
| Email |
kunalaudichya@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Kunal Audichya |
| Address |
Pacific Dental college and hospital, Debari, Udaipur |
| 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 Kunal Audichya |
Pacific Dental College and Hospital, Debari |
Pediatric and preventive dentistry department, room number 9.
Udaipur
RAJASTHAN |
7597172819
kunalaudichya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pacific Dental College and Hospital Udaipur Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Grossly decayed teeth
Root stumps |
| Patients |
(1) ICD-10 Condition: K029||Dental caries, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Straight Elevator |
The conventional straight elevator is a standard straight-shaft elevator routinely used in pediatric dentistry for luxation and elevation of primary teeth. |
| Intervention |
Twisted Elevator |
The twisted elevator is a modified dental elevator with a spiral or twisted shank design intended to improve rotational force transmission and provide better grip and mechanical advantage during extraction of deciduous teeth. The elevator is used for luxation and elevation of primary teeth indicated for extraction due to mobility, over-retention, or pathology. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Deciduous teeth indicated for extraction due to being grossly decayed or presenting as root stumps.
Tooth extractable using elevation/luxation technique without surgical sectioning.
ASA I or II physical status.
Cooperative behavior allowing extraction under local anesthesia.
Parental/guardian consent obtained; child assent where appropriate.
Available for postoperative follow-up (24 hours) |
|
| ExclusionCriteria |
| Details |
Children with special healthcare needs
Frankl behavior rating 1 or 2
Pre-shedding mobility or pathological mobility of teeth
Teeth with half root length
Teeth with crown fracture extending sub-gingivally |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Extraction time
Soft tissue trauma
Intra operative complications |
Extraction time
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Post operative pain & swelling
Heart Rate
Oxygen Saturation |
Base line, 24hr |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
25/12/2025 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 aims to evaluate and compare the effectiveness of a newly designed twisted elevator versus the conventional straight elevator in pediatric patients requiring extraction of grossly decayed primary teeth and root stumps. Eligible children will be randomly assigned to two groups: Group A (straight elevator) and Group B (twisted elevator). The study will assess extraction time, soft tissue trauma (modified Laskin criteria), intraoperative complications (root or bone fracture), postoperative pain and swelling, and physiological parameters (heart rate and oxygen saturation). It is hypothesized that the twisted elevator may reduce procedure time, tissue trauma, and postoperative discomfort, offering a safe and effective alternative to the conventional straight elevator in pediatric extractions. |