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CTRI Number  CTRI/2025/08/093421 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 21/08/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Randomized Clinical Evaluation of Triple Antibiotic Paste, Modified TAP, and Metapex in Treating Infected Primary Molars with Poor Prognosis 
Scientific Title of Study   Comparative evaluation of the clinical and radiographic success rates of Triple antibiotic paste, modified triple antibiotic paste and Metapex in the treatment of infected primary molars with poor prognosis: A Randomized clinical study. 
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 Yash Jaju 
Designation  2nd yr MDs 
Affiliation  JMFs ACPM Dental college and Hospital, Dhule 
Address  Dept of Pediatric and preventive dentistry JMfs ACPM Dental and hospital, near sakri road, Dhule, 424001

Dhule
MAHARASHTRA
424001
India 
Phone  9404666784  
Fax    
Email  jajuyash7998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sandesh Bansal 
Designation  Reader 
Affiliation  JMFs ACPM Dental college and Hospital, Dhule 
Address  Dept of Pediatric and preventive dentistry JMfs ACPM Dental and hospital, near sakri road, Dhule, 424001

Dhule
MAHARASHTRA
424001
India 
Phone  9689141996  
Fax    
Email  sandesh.bansal@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Yash Jaju 
Designation  2nd yr MDs 
Affiliation  JMFs ACPM Dental college and Hospital, Dhule 
Address  Dept of Pediatric and preventive dentistry JMfs ACPM Dental and hospital, near sakri road, Dhule, 424001

Dhule
MAHARASHTRA
424001
India 
Phone  9404666784  
Fax    
Email  jajuyash7998@gmail.com  
 
Source of Monetary or Material Support  
JMFs ACPM Dental college and Hospital, Sakri road, Dhule, 424001 Infrastructural support 
 
Primary Sponsor  
Name  Dr Yash Jaju 
Address  JMFs ACPM Dental college and Hospital, Dhule, 424001 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yash Jaju  JMfs ACPM Dental college and hospital  Dept no 5, Building no.2, Departmnent of pediatric and preventive dentistry.
Dhule
MAHARASHTRA 		 9404666784

jajuyash7998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE 9Reg. under NECRBHR, MoHFW, Govt of india- file No EC/NEW/INST/2022/2959  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K041||Necrosis of pulp, (2) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Metapex  Calcium Hydroxide and iodoform paste is inserted into the root canals until the teeth exfoliates and follow up will be taken till 12 months. 
Intervention  Modified triple antibiotic paste,   Ciprofloxacin 500mg Metronidazole 400mg Doxycycline 200mg Cefixime 200mg all the Tablets will be crushed in morter pestle and then will be mixed with propylene glycol and then inserted into the canal until the tooth exfoliates and follow up will be taken till 12 months. 
Comparator Agent  Triple antibiotic paste  Ciprofloxacin 400mg Metronidazole 400mg Doxycycline 200mg all the Tablets will be crushed in morter pestle and then will be mixed with propylene glycol and then inserted into the canal until the tooth exfoliates and follow up will be taken till 12 months. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Primary molars selected in this study will be based on clinical and radiographic screening.
1. Pulpally involved primary teeth (nonvital)
2. Gingival abscess, presence of fistula
3. Failed pulpotomy
4. Teeth with radiographic evidence of internal or external root resorption
5. Furcation or periapical radiolucency.
6. Excessive root resorption involving more than half of the root
 
 
ExclusionCriteria 
Details  1. Teeth with pulpal floor perforation
2. Systemically compromised and patients with history of drug allergy
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Resolution of pain, tenderness, mobility, clinically  1 week, 1 month, 3 months, 6months, 9 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic resolution of radiolucency.  3 months, 6months, 9 months, 12 months 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/09/2025 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 study aims to evaluate and compare the clinical and radiographic success of three intracanal medicaments—Triple Antibiotic Paste (TAP), Modified Triple Antibiotic Paste (MTAP), and Metapex—in treating infected primary molars with poor prognosis in children.

The importance lies in preserving primary teeth until natural exfoliation to prevent functional and developmental issues caused by premature tooth loss. The Lesion Sterilization and Tissue Repair (LSTR) technique, using antibiotic pastes, offers a less invasive alternative to conventional pulpectomy.

Key Points:

  • Triple antibiotic paste (TAP) includes ciprofloxacin, metronidazole, and minocycline.

  • Modified TAP substitutes minocycline with doxycycline or adds cefixime.

  • Metapex is a calcium hydroxide and iodoform paste commonly used in pulpectomy.

Objectives:

  • Evaluate individual and comparative success of TAP, MTAP, and Metapex in treating nonvital primary molars.

    Methodology:

    • 75 children divided into 3 groups (n=25 each).

    • Group I: TAP

    • Group II: MTAP

    • Group III: Metapex

    • Clinical and radiographic evaluation at 1, 3, 6, 9, and 12 months.

    • Data analyzed using SPSS software.

      Clinical Procedures:

      • LSTR involved medicament placement on pulpal floor and sealing with GIC.

      • Pulpectomy involved chemo-mechanical preparation and obturation with Metapex followed by stainless steel crown restoration.

 
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