| CTRI Number |
CTRI/2025/03/083300 [Registered on: 25/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Pain Relief Before Dental Numbing: Comparing Two Medicines for Kids with Toothaches |
|
Scientific Title of Study
|
Comparative evaluation of effect of pre-emptive oral medication of ibuprofen-paracetamol combination, and an oral enzymatic complex on the anesthetic efficacy of inferior alveolar nerve block in children with symptomatic irreversible pulpitis: A prospective, double-blind, randomized 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 |
Kirti Agrawal |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College and Hospital, Debari, Udaipur |
| Address |
Pacific Dental College and Hospital Debari room no 9 deparment of pediatric and preventive dentistry Udaipur Rajasthan India
Pacific Dental College and Hospital Debari room no 9 deparment of pediatric and preventive dentistry Udaipur Rajasthan India 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
08320909722 |
| Fax |
|
| Email |
kagrawal2021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dinesh Rao |
| Designation |
Head of Department |
| Affiliation |
Pacific Dental College and Hospital, Debari, Udaipur |
| Address |
Pacific Dental College and Hospital Debari room no 9 deparment of pediatric and preventive dentistry Udaipur Rajasthan India
Pacific Dental College and Hospital Debari room no 9 deparment of pediatric and preventive dentistry Udaipur Rajasthan India 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
9414158235 |
| Fax |
|
| Email |
pedodinesh2003@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kirti Agrawal |
| Designation |
Post graduate student |
| Affiliation |
Pacific Dental College and Hospital, Debari, Udaipur |
| Address |
Pacific Dental College and Hospital Debari room no 9 deparment of pediatric and preventive dentistry Udaipur Rajasthan India
Pacific Dental College and Hospital Debari room no 9 deparment of pediatric and preventive dentistry Udaipur Rajasthan India 313024
Udaipur
RAJASTHAN
313024
India |
| Phone |
08320909722 |
| Fax |
|
| Email |
kagrawal2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific dental college and hospital Room no. 9 Department of pediatric and preventive dentistry Debari Udaipur Rajasthan India 313024 |
|
|
Primary Sponsor
|
| Name |
Kirti Agrawal |
| Address |
Pacific Dental College and Hospital room no. 9 Department of Pediatric and Preventive dentistry Debari Udaipur Rajasthan India 313024 |
| 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 Kirti Agrawal |
Pacific dental college and hospital Debari Udaipur 313024 |
Room no 9 Department of pediatric and preventive dentistry Pacific Dental College and Hospital Debari Udaipur
313024
Udaipur
RAJASTHAN |
08320909722
kagrawal2021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethic Committee 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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ibuprofen-paracetamol combination |
Ibuprofen plus paracetamol combinations provided better analgesia than either drug alone evaluate at the intervals of 6 hours, 12 hours, 24 hours, 48 hours, 72 hours |
| Comparator Agent |
Multivitamin tablet |
contains combination of vitamins and minerals including other ingredients evaluate at the intervals of 6 hours, 12 hours, 24 hours, 48 hours, 72 hours |
| Comparator Agent |
Oral enzymatic complex |
Contains proteases, such as bromelain (a proteolytic enzyme) and other ingredients like rutoside (a glycoside combining the flavonol quercetin and the disaccharide rutinose) on reducing pain, oedema, and inflammation evaluate at the intervals of 6 hours, 12 hours, 24 hours, 48 hours, 72 hours |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Children who are mentally capable of communication and those who can follow the instructions and be able to interpret the pain perception appropriately
2. Frankl behavior rating of 3 or 4
3. Primary mandibular molar with symptomatic irreversible pulpitis
4. Children, who are cooperative enough to undergo pulp therapy
|
|
| ExclusionCriteria |
| Details |
1. Children allergic to any of the medication
2. Children who require special healthcare needs
3. Frankl behavior rating 1 or 2
4. Periapical infection |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| oral enzymetic complex is equally effective as ibugesic and paracetamol in reducing pain post operatively |
pain assessment before and after injecting local anesthesia and also post operatively after 6,12,24,48,72 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| oral enzymetic complex is effective in reducing pain post operatively |
Pain reduction was seen after 15 mins of local anesthesia administration ans post oiperatively after 6,12,24,48,72 hours |
|
|
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 4 |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/04/2025 |
| 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
|
Aim: To evalute and compare pre-post operative effects of preemptive oral medication of ibuprofen-paracetamol combination or an oral enzymatic complex on anesthetic efficacy of Inferior alveolar nerve block in children with symptomatic irreversible pulpitis. Methodology: Diagnosis of symptomatic irreversible pulpitis will be done using cold thermal test, percussion test, periapical radiograph, visual analogue scale, SpO2, heart rate will be evaluated before giving preemptive oral medication either Ibugesic-paracetamol combination or oral enzymatic complex. After 60 minutes of preemptive oral medication Inferior alveolar nerve block will be given, 15 minutes later cold test will be done. Pulp therapy will be performed followed by evaluation of visual analogue scale, heart rate will be done. Proposed conclusion: Pain after Inferior alveolar nerve block and endodontic treatment may be less in oral-enzymatic complex group as compared to other groups. |