| CTRI Number |
CTRI/2026/02/102924 [Registered on: 03/02/2026] Trial Registered Prospectively |
| Last Modified On: |
02/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing two Antibiotic Pastes with each other for thier efficacy for Infection Control and Pain Relief in milk teeth of Young Children: A Clinical Study |
|
Scientific Title of Study
|
Comparative evaluation of antibiotic paste (cotrimoxazole) V/S antibiotic paste (ciprofloxacin and metronidazole) in reduction of CFU and alleviation of post-operative pain in children aged 4-8 years. A 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 |
Dr Nirbhay Vashistha |
| Designation |
Postgraduate Student |
| Affiliation |
RUHS college of dental sciences, Shastri nagar, Jaipur, Rajasthan, 302016 |
| Address |
Room no. 7, Department of Pediatric and Preventive Dentistry, RUHS College of Dental Sciences, Shastri nagar, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
9829599687 |
| Fax |
|
| Email |
nirbhaylive234@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ambika Singh Rathore |
| Designation |
Professor |
| Affiliation |
RUHS college of dental sciences, Shastri nagar, Jaipur, Rajasthan, 302016 |
| Address |
Room no. 7, Department of Pediatric and Preventive Dentistry, RUHS College of Dental Sciences, Shastri nagar, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
8107132663 |
| Fax |
|
| Email |
dr.ambika.rathore@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ambika Singh Rathore |
| Designation |
Professor |
| Affiliation |
RUHS college of dental sciences, Shastri nagar, Jaipur, Rajasthan, 302016 |
| Address |
Room no. 7, Department of Pediatric and Preventive Dentistry, RUHS College of Dental Sciences, Shastri nagar, Jaipur
Jaipur
RAJASTHAN
302016
India |
| Phone |
8107132663 |
| Fax |
|
| Email |
dr.ambika.rathore@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room No. 7, Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri Nagar, Jaipur, 302016 |
|
|
Primary Sponsor
|
| Name |
Dr Nirbhay Vashistha |
| Address |
Room No. 7, Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri Nagar, Jaipur, 302016 |
| 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 Nirbhay Vashistha |
RUHS College Of Dental Sciences |
Room No. 7 Department of Pediatric and Preventive Dentistry, RUHS College Of Dental Sciences, Shastri Nagar, 302016
Jaipur
RAJASTHAN |
9829599687
nirbhaylive234@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee RUHS CDS Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B999||Unspecified infectious disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Antibiotic paste of ciprofloxacin and metronidazole |
After Bio mechanical preparation, baseline bacterial sample will be taken followed by antibiotic paste placement and post 72 hr after removing temporary restoration bacterial sample will be taken. Using a visual analogue scale, pain scores will be measured at preoperative and at post 72 hr.
|
| Intervention |
Antibiotic Paste of Cotrimoxazole |
After Bio mechanical preparation, baseline bacterial sample will be taken followed by antibiotic paste placement and post 72 hr after removing temporary restoration bacterial sample will be taken. Using a visual analogue scale, pain scores will be measured at preoperative and at post 72 hr.
|
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children aged 4-8 years old.
Frankel rating 3 or 4.
Primary molars with chronic symptomatic irreversible pulpitis.
Root resorption 1/3rd. or less. |
|
| ExclusionCriteria |
| Details |
Frankel rating 1 or 2.
Primary molars with abscess or sinus.
Patients on antibiotics or analgesics.
Root resorption more than 1/3rd.
Medically compromised or children with any systemic disorders. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Microbial contamination, Colony Forming Unit (CFU/ml) count. |
At Baseline and 72hr after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pain using visual analogue scale |
preoperative and 72hr after intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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 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
|
AIM: To compare the effectiveness of antibiotic paste of (Cotrimoxazole) with antibiotic paste of (Ciprofloxacin and Metronidazole) in reducing bacterial colony-forming units (CFU) and alleviating post-operative pain in children aged 4-8 years undergoing endodontic treatment.
40 healthy children aged between 4-10 years, who reported in the Department of Pediatric and Preventive Dentistry of RUHS College Of Dental Sciences, Jaipur that met the defined inclusion criteria will be recruited to participate in this clinical study and randomized into two groups:
Group 1 – Antibiotic paste (Cotrimoxazole)
Group 2 – Antibiotic paste (Ciprofloxacin and Metronidazole)
Succeeding access opening and Bio mechanical preparation, baseline bacterial sample will be taken using a sterile swab stick. After sample collection intracanal medicaments (both AB paste) will be placed in the root canals in respective groups. Using a visual analogue scale, pain scores will be measured at preoperative Sample will be sent to lab for bacterial Colony Forming Unit (CFU/ml) count. Post 72 hrs After removing temporary restoration bacterial sample will be taken like baseline sample collection. Visual analogue scale will be used the measure pain. Sample will be sent to lab for bacterial evaluation.
|