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CTRI Number  CTRI/2022/05/042944 [Registered on: 31/05/2022] Trial Registered Prospectively
Last Modified On: 23/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to compare the effects of different concentrations of antibiotic paste for treatment of carious and infected lower posterior primary teeth in children  
Scientific Title of Study   Comparative Evaluation of Lesion Sterilization and Tissue Repair in Pulpally Involved Primary Molars using Modified Triple Antibiotic Paste with Different Concentrations: An In Vivo Interventional Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mainak Das 
Designation  Post Graduate MDS Student 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  Department of Paediatric and Preventive Dentistry GNIDSR 6th Floor Room no.1 157/F Nilgunj Road Panihati Kolkata West Bengal 700114

Kolkata
WEST BENGAL
700114
India 
Phone  9433291551  
Fax    
Email  drmdas85@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shabnam Zahir 
Designation  Professor and HOD  
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  Department of Paediatric and Preventive Dentistry GNIDSR 6th floor Room no 4 157/F Nilgunj Road Panihati Kolkata West Bengal 700114

Kolkata
WEST BENGAL
700114
India 
Phone  9830215726  
Fax    
Email  dr.shabnam.zahir@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mainak Das 
Designation  MDS Postgraduate Student 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  Department of Paediatric and Preventive Dentistry GNIDSR 6th floor Room no 1 157/F Nilgunj Road Panihati Kolkata West Bengal

Kolkata
WEST BENGAL
700114
India 
Phone  9433291551  
Fax    
Email  drmdas85@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Institute of Dental Sciences and Research 157/F Nilgunj Road Panihati Kolkata West Bengal 700114 
 
Primary Sponsor  
Name  Dr Mainak Das 
Address  42/103, New Ballygunge Road, Nirmal Tara Apartment, Kolkata 700039 
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 Mainak Das  Guru Nanak Institute of Dental Sciences and Research  Department of Paediatric and Preventive Dentistry 6th Floor Room no 2 157/F Nilgunj Road Panihati Kolkata West Bengal 700114
Kolkata
WEST BENGAL 
9433291551

drmdas85@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Guru Nanak Institute of Dental Sciences and Research Panihati Kolkata 700114  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Modified Triple Antibiotic Paste consisting of Ciprofloxacin, Metronidazole and Amoxicillin in three different concentrations 0.5 mg/ml, 2.5 mg/ml and 5 mg/ml  An in vivo interventional study will be conducted among children of age group 5-9 years with indication for pulp therapy using Modified Triple Antibiotic Paste (Ciprofloxacin, Metronidazole and Amoxicillin) in three different concentrations (0.5 mg/ml, 2.5 mg/ml and 5 mg/ml) for LSTR of primary molars and comparative evaluation of clinical and radiographic success of LSTR will be done at specific time intervals. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children with deep caries involving pulp in primary molars, Irreversible pulpitis, Irreversible pulpitis with apical periodontitis, Primary molar with at least two-thirds of the roots, Primary molar with restorable crown structure 
 
ExclusionCriteria 
Details  Primary molar with dentigerous cyst, Special children with a physical or emotional alteration, Children with systemic diseases, Previous
history of allergy to antibiotics used in the study, Caries in primary teeth exhibiting pre-shedding mobility, Carious perforation of floor of primary molar, Molar with more than 2/3rd root resorbed, Molars with gross destruction of alveolar bone, Molar with non restorable crown structure 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Decrease in pain, swelling and mobility (other than shedding mobility) in primary infected molars  3, 6 and 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic evidence of decrease in intra radicular radiolucency, continuity of lamina dura and absence of internal resorption  6 and 12 months 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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)   10/06/2022 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Maintenance of primary dentition is imperative for the development of arch form, esthetics, function, mastication, and normal eruption of permanent teeth. Premature loss can cause various problems such as ectopic eruption, space loss for the successor permanent teeth, alterations in speech, and impairment of function. Hence, decayed primary teeth should not be extracted and treated whenever possible. Pulpectomy is generally recommended as a treatment of choice in such cases. But several factors make conventional pulpectomy arduous. The typical primary tooth morphology (tortuous root canals, presence of multiple accessory canals, ramifications, and ample medullary bone spaces that favor dissemination of infection) often presents a challenging task to the clinician. In addition to that, obtaining a hermetic seal is difficult due to the lack of apical closure following physiologic root resorption owing to the proximity of the developing permanent tooth germ to the roots of the primary teeth. A further challenge presented to the dentist in rendering effective endodontic treatment is the behavior management of uncooperative children. Thus to overcome these hurdles, the concept of lesion sterilization and tissue repair (LSTR) which involves the topical placement of triple antibiotic pastes (TAPs) evolved which aims to disinfect the canal space thus promoting repair of damaged tissue. LSTR involves the use of three antibiotics/antibacterial drugs namely, Metronidazole, Ciprofloxacin and Minocycline with macrogol (M) as the ointment base and propylene glycol (P) as the carrier. The prime concern regarding the use of triple antibiotic paste is the discoloration caused by minocycline. To overcome this, alternative medications such as clindamycin, cefaclor, amoxycillin have been proposed. The American Association of Endodontists (AAE) 2018 protocol recommends Triple Antibiotics Paste (TAP) should be mixed equally (1:1:1) to a final concentration of  1 – 5 mg/ml. At this concentration, TAP is conducive with stem cell survival and proliferation and also effective in eliminating microorganisms within the root canal. But no standardization regarding the dosage of drugs used in the antibiotic combination of LSTR in deciduous teeth has been done till date.

An in vivo interventional study will be conducted among children of age group 5-9 years with indication for pulp therapy using Modified Triple Antibiotic Paste (Ciprofloxacin, Metronidazole and Amoxicillin) with different concentrations (0.5 mg/ml, 2.5 mg/ml and 5 mg/ml) for LSTR of primary molars and comparative evaluation of clinical and radiographic success of LSTR will be done at specific time intervals.

 
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