| CTRI Number |
CTRI/2025/06/088998 [Registered on: 17/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the Effect of Pain-Relief Medicines Given Before Treatment on Pain During and After Root Canal in Children’s Back Teeth |
|
Scientific Title of Study
|
Assessing Impact of Preoperative Analgesics on Interoperative And
Postoperative Pain in Pediatric Patients Undergoing Primary Molar Pulpectomy : 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 |
Somya Seth |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
7597698819 |
| Fax |
|
| Email |
sdc.ssomya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh Kumar B |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9952007702 |
| Fax |
|
| Email |
dineshkumarb.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh Kumar B |
| Designation |
Senior Lecturer |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic-28, Department of Pediatric and Preventive Dentistry
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9952007702 |
| Fax |
|
| Email |
dineshkumarb.sdc@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India
Pin code-600077
|
|
|
Primary Sponsor
|
| Name |
Somya Seth |
| Address |
Saveetha Dental College And Hospitals
162, Poonamallee High Rd, Velappanchavadi, Chennai, Tamil Nadu, India
Pin code-600077 |
| 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 Somya Seth |
Saveetha Dental College And Hospitals |
Clinic-28,Department of Pediatric and Preventive Dentistry
162, Poonamallee High Rd, Velappanchavadi
Thiruvallur
TAMIL NADU |
7597698819
sdc.ssomya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha Dental College and Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ibugesic (Ibuprofen + Paracetamol)(tablet)
1.Ibugesic 200mg
2.Ibugesic 400mg |
Administered orally as a single dose 30 minutes prior to the dental procedure. Dosage calculated based on body weight using Clark’s rule. Acts as an active preoperative analgesic. |
| Intervention |
Paracetamol (tablet)
1.Paracetamol 250mg
2.Paracetamol 500mg |
Administered orally as a single dose 30 minutes prior to the dental procedure. Dosage calculated based on body weight using Clark’s rule. Acts as an active preoperative analgesic. |
| Comparator Agent |
Vitamin B complex (tablet) |
Administered orally 30 minutes prior to the procedure. Used as a placebo to compare against active analgesics. Does not have analgesic properties. |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
9.00 Year(s) |
| Gender |
Both |
| Details |
1.Children aged 4 to 9 years.
2.Children who need pulpectomy in mandibular primary molar
3.Children who are healthy (ASA I or II).
4.Children who can understand and follow simple instructions.
5.Children having Frankl Behaviour rating scale of 3 or 4.
6.Children whose parents or guardians give written consent to take part in the study.
|
|
| ExclusionCriteria |
| Details |
1.Children who have allergies to any pain medication (like ibuprofen or paracetamol).
2.Children who are already taking painkillers or antibiotics before the treatment.
3.Children with acute infections, facial swelling, or abscess near the tooth.
4.Children with serious medical problems (e.g., heart conditions, kidney or liver disease).
5.Children with special healthcare needs or behavioral issues that may affect treatment.
6.Children who have received pulpectomy treatment in the same tooth earlier.
7.Children whose tooth is indicated for extraction (e.g., due to severe decay, mobility). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in postoperative pain following primary molar pulpectomy in children. |
1.During local anaesthesia injection.
2.During the procedure
3.1 hour post procedure
4.4 hours post procedure
5.6 hours post procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 4 |
|
Date of First Enrollment (India)
|
27/06/2025 |
| 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="1"
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 randomized clinical trial aims to evaluate the effectiveness of preoperative analgesics in reducing pain during and after pulpectomy procedures in children aged 4 to 9 years. The study will compare three groups: one receiving ibugesic , another receiving paracetamol , and a third receiving a placebo (Vitamin B-complex). The primary objective is to determine whether administering analgesics before treatment can improve pain control at various stages of the procedure. Pain levels will be assessed at five key time points: during local anesthesia injection, during the procedure, and at 1 hour, 4 hours, and 6 hours following the treatment. The results of this study may contribute to improved pain management strategies in pediatric dental practice, enhancing the comfort and overall experience for young patients undergoing pulpectomy. Study Hypothesis:
Children who receive ibugesic or paracetamol before a pulpectomy will report lower levels of postoperative pain compared to those who receive a placebo. |