| CTRI Number |
CTRI/2025/03/081998 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Different Ways to Reduce Pain and Anxiety in Children During a Tooth Treatment for Serious Pulp Infection |
|
Scientific Title of Study
|
A Comparative evaluation of four different
Intrapulpal agents in Pulpectomy Procedures for reducing pain and anxiety in Children with
Symptomatic Irreversible Pulpitis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nandini S |
| Designation |
Post Graduate student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
room no 6B, department of pedodontics and preventive dentistry
Chennai
TAMIL NADU
600001
India |
| Phone |
7358345187 |
| Fax |
|
| Email |
nandinisundar129@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Senthil Eagappan AR |
| Designation |
Professor |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
room no 6, department of pedodontics and preventive dentistry,CDCRI
60 Feet Rd., Kelambakkam, Tamil Nadu 603103
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9894212394 |
| Fax |
|
| Email |
dr.eaga_ars@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nandini S |
| Designation |
Post Graduate student |
| Affiliation |
Chettinad Dental College and Research Institute |
| Address |
Room No 6B, department of pedodontics and preventive dentistry, 60 Feet Rd., Kelambakkam, Tamil Nadu 603103
Chennai
TAMIL NADU
603103
India |
| Phone |
07358345187 |
| Fax |
|
| Email |
nandinisundar129@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Dental College and Research Institute,
60 Feet Rd, Kelambakkam, Tamil Nadu, India 603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Dental College and Research Institute |
| Address |
60 Feet Rd, Kelambakkam, Tamil Nadu, India 603103 |
| 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 |
| Nandini S |
Chettinad Dental College and Research Institute |
Room No 6B, 3rd floor, department of pedodontics and preventive dentistry, CDCRI, 60 Feet Rd., Kelambakkam, Tamil Nadu 603103
Kancheepuram
TAMIL NADU |
07358345187
nandinisundar129@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee Chettinad dental college and Research Institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Endo-ice |
Dental refrigerant spray
-26.2 degrees Celsius contains butane,propane, and isobutane and 1,1,1,2-tetrafluoroethane applied intrapulpally using cotton pellet for 1 minute
|
| Comparator Agent |
intrapulpal injection |
local anesthetic agent-lidocaine is delivered intrapulpally using a syringe which is the standard line of care- 1ml for 1 minute |
| Intervention |
precooled topical anesthesia
|
lidocaine spray precooled to 4 degree Celsius/39 degrees Fahrenheit—applied intrapulpally
using a cotton pellet for 1 minute |
| Intervention |
regular topical anesthesia |
lidocaine spray -applied intrapulpally using a cotton pellet for 1 minute |
|
|
Inclusion Criteria
|
| Age From |
5.00 Day(s) |
| Age To |
8.00 Day(s) |
| Gender |
Both |
| Details |
Healthy children ASA 1
Primary mandibular molar requiring supplemental anesthesia for pulpectomy
Depicting normal apical tissue radiographically.
Child who will demonstrate appropriate understanding of the pain scale
|
|
| ExclusionCriteria |
| Details |
Children who are allergic to amides are suffering from any systemic diseases.
Children with a previous history of bad dental experience.
Primary mandibular molar with pulpal necrosis
Depicting radiolucency in apical region, radiographically
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| heart rate—physiological reading to assess anxiety of the children before, during and after administration of intrapulpal anesthesia |
before, during and after administration of intrapulpal anesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| wong bakers faces pain scale to assess pain before, during & after administration of intrapulpal anesthesia |
before during & after administration of intrapulpal anesthesia |
| FLACC scale to assess the behavior of the child before, during & after administration of intrapulpal anesthesia |
before, during & after administration of intrapulpal anesthesia |
|
|
Target Sample Size
|
Total Sample Size="76"
Sample Size from India="76"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
20/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
submitted to the world journal of dentistry |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [nandinisundar129@gmail.com].
- For how long will this data be available start date provided 01-06-2025 and end date provided 31-12-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, parallel-group, single-center trial comparing the effectiveness of different intrapulpal techniques
in reducing pain and anxiety for 3 months in 76 children that will be conducted in India. The primary outcome
measures will be heart rate measured before, during, and after administration of
intrapulpal anesthesia. The secondary outcomes will be WBFPS and FLACC scales measured
before, during and after administration of intrapulpal anesthesia |