| CTRI Number |
CTRI/2025/03/082111 [Registered on: 10/03/2025] Trial Registered Prospectively |
| Last Modified On: |
10/03/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Post-Treatment Pain in Children Undergoing Root Canal Treatment with Different Types of Files |
|
Scientific Title of Study
|
Comparative evaluation of postoperative pain using manual, single file and multiple file during root canal treatment in primary molars - A Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Elanthendral Saravanan |
| Designation |
Post graduate student |
| Affiliation |
Saveetha Dental College and Hospital Tamilnadu |
| Address |
Clinic 28,department of pediatric and preventive dentistry,Saveetha dental college,Seneerkuppam
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
8190996644 |
| Fax |
|
| Email |
152211003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital Tamilnadu |
| Address |
Clinic 28,department of pediatric and preventive dentistry,Saveetha dental college,Seneerkuppam
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ganesh Jeevanandan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospital Tamilnadu |
| Address |
Clinic 28,department of pediatric and preventive dentistry,Saveetha dental college,Seneerkuppam
Chennai
Chennai
TAMIL NADU
600077
India |
| Phone |
9884293869 |
| Fax |
|
| Email |
helloganz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals,162,Poonamallee high road,Chennai 600077,India |
|
|
Primary Sponsor
|
| Name |
Elanthendral Saravanan |
| Address |
162,Poonamallee high road,Velappanchavadi,Chennai |
| 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 |
| Ganesh Jeevanandan |
Saveetha dental college and hospitals |
Clinic 28,department of pediatric and preventive dentistry,
Chennai,Tamil Nadu
Chennai
TAMIL NADU |
09884293869
helloganz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha dental college and hospitals Ethics Committee |
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 |
| Comparator Agent |
K file |
Postoperative pain will be assessed after 12,24,48 hours. |
| Intervention |
Kedo Nano Plus |
Postoperative pain will be assessed after 12,24,48 hours. |
| Intervention |
Pro AF Babyplus |
Postoperative pain will be assessed after 12,24,48 hours. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
pulpectomy in primary mandibular molars.
Presence of non-vital pulp or irreversible pulpitis.
Teeth with restorable structure after endodontic treatment.
Cooperative behavior based on the Frankl Behavior Rating Scale (positive or definitely positive).
|
|
| ExclusionCriteria |
| Details |
Teeth with internal or external resorption.
Advanced root resorption beyond 1/3rd of the root length.
History of systemic conditions affecting pain perception.
Teeth with more than one session of prior endodontic treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain will be assessed by using 4 point pain intensity scale |
12,24,48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
nor applicable |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="0"
Months="0"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 aims to evaluate and compare postoperative pain levels following root canal treatment in primary molars using three different instrumentation techniques: manual hand files, single-file rotary systems, and multi-file rotary systems.
|