| CTRI Number |
CTRI/2024/09/074328 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
19/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative evaluation of the effect of common analgesics on pulpal sensibility tests in children aged between 6 to 8 years: randomized, controlled clinical trial’ |
|
Scientific Title of Study
|
Comparative evaluation of the effect of common analgesics on pulpal sensibility tests in children aged between 6 to 8 years: A prospective, parallel design, randomized, controlled 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 |
DIVYA RAJPUROHIT |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College And Hospital Debari . |
| Address |
Pacific Dental College And Hospital Debari department of pediatric and preventive dentistry, room number 9
Pacific Dental College And Hospital Debari department of pediatric and preventive dentistry, room number 9
Udaipur
RAJASTHAN
313024
India |
| Phone |
7340659914 |
| Fax |
|
| Email |
divyarajpurohit2999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
pacific dental college and hospital debari |
| Address |
Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital debari
Pacific Dental College And Hospital, Debari, Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07340659914 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department PG Guide |
| Affiliation |
pacific dental college and hospital debari |
| Address |
Department of Pediatric and preventive dentistry room no 9 pacific dental college and hospital debari
Pacific Dental College And Hospital, Debari, Udaipur
Udaipur
RAJASTHAN
313024
India |
| Phone |
07340659914 |
| Fax |
|
| Email |
pedodinesh2003@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Pacific dental college and Hospital, debari 313024
|
|
|
Primary Sponsor
|
| Name |
Divya Rajpurohit |
| Address |
Pacific Dental College And Hospital Debari Udaipur 313024 |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dinesh Rao |
Pacific Dental College And Hospital Udaipur 313024 |
Departement Of Pediatric And Preventive Dentistry First Floor Room Number Nine Pacific Dental College And Hospital Debari 313024
Udaipur
RAJASTHAN |
9414158235
pedodinesh2003@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Comimittee Sai Tirupati University Udaipur Rajasthan India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, (2) ICD-10 Condition: K040||Pulpitis, (3) ICD-10 Condition: A409||Streptococcal sepsis, unspecified, (4) ICD-10 Condition: B950||Streptococcus, group A, as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Acetaminophen |
Pulp sensibility test will be performed and sensibility will be checked with EPT and cold test |
| Intervention |
Ibuprofen
|
Evaluation of the effect of common analgesics on pulpal sensibility tests in children will be done using EPT And Cold test at 0, 20, and 60 minutes |
| Comparator Agent |
Placebo |
valuation of the effect of common analgesics on pulpal sensibility tests in children will be done using EPT And Cold test at 0, 20, and 60 minutes |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
1 Medically fit children aged between 6 and 8 years
2 Children who are mentally capable of communication and those who can follow the instructions and are able to interpret the pain perception appropriately
3 Primary teeth with severe irreversible pulpitis
4 Children who haven’t used any analgesics or central nervous system depressants in the past 6 hours prior to their visit
5 Children who are cooperative enough to undergo procedures
|
|
| ExclusionCriteria |
| Details |
1 Children who could not take acetaminophen or ibuprofen
2 Children with toothache due to periapical disease
3 History of systemic mental or physical disorders
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intake of either acetaminophen or Ibuprofen may affect the pulpal response to the cold EPT test, especially in teeth with SIP. |
evaluation will be done at 0,20.60 minutes of interval |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| masking effect of these analgesics on pulpal sensibility tests and consideringing the possibility of incorrect diagnosis |
evaluation will be done at a 0–20, 60-minute interval |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
30/09/2024 |
| 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) |
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
|
Arriving at an accurate diagnosis is one of the most important steps before initiating any dental procedures. correct diagnosis is both an art and science, not only in adult dentistry but also in pediatric dentistry. Thus, clinicians must take into account various variables, including the results of clinical tests, radiographic findings, dental history, and their own clinical knowledge and experience to reach an accurate diagnosis. Pulpal sensibility Tests such as the cold, heat, and electric pulp tests (EPT) are important tools in endodontic diagnosis. The cold test is one of the most common endodontic diagnostic tests for the indirect assessment of pulp vitality. It is usually performed in combination with EPT to increase the validity and reliability of the findings To date, research on the comparative effects of various analgesics on pulpal sensitivity tests in pediatric populations remains relatively limited. Therefore, this study aims to bridge this gap by conducting a comprehensive comparative evaluation. By systematically examining the effects of common analgesics on different pulpal sensibility tests, we can provide valuable insights into the potential interactions between pain management and diagnostic accuracy in pediatric dentistry. Thus, the present study aimed to investigate the effect of 2 commonly used analgesics namely, ibuprofen and acetaminophen on pulpal sensibility test (cold test and EPT) results and evaluate the masking effect of these medications on endodontic symptoms in primary teeth |