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CTRI Number  CTRI/2025/08/092285 [Registered on: 04/08/2025] Trial Registered Prospectively
Last Modified On: 30/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study on the Effectiveness of Chitosan Nanoparticles in Healing Decayed Primary Molars in Children 
Scientific Title of Study   A Randomized Controlled Trial to evaluate the efficacy of chitosan nanoparticle as a vehicle in lesion sterilisation and tissue repair(LSTR) in primary molars 
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 SREELAKSHMI JAYALAL 
Designation  POST GRADUATION 
Affiliation  Santosh Dental College Santosh Deemed to be University 
Address  Department of Pediatric and Preventive Dentistry Santosh Dental College Santosh Deemed to be University

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  07907193209  
Fax    
Email  sreelakshmijayalal98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR NIDHI GUPTA 
Designation  PROFESSOR AND HEAD OF DEPARTMENT 
Affiliation  Santosh Dental College Santosh Deemed to be University 
Address  Department of Pediatric and Preventive Dentistry Santosh Dental College Santosh Deemed to be University

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  9810358916  
Fax    
Email  nid_gup6@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR NIDHI GUPTA 
Designation  PROFESSOR AND HEAD OF DEPARTMENT 
Affiliation  Santosh Dental College Santosh Deemed to be University 
Address  Department of Pediatric and Preventive Dentistry Santosh Dental College Santosh Deemed to be University

Ghaziabad
UTTAR PRADESH
201009
India 
Phone  9810358916  
Fax    
Email  nid_gup6@yahoo.co.in  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  DRSREELAKSHMI JAYALAL 
Address  SANTOSH DENTAL COLLEGE AND HOSPITAL PRATAP VIHAR GHAZIABAD 201009 UTTAR PRADESH INDIA 
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 SREELAKSHMI JAYALAL  Santosh Dental College and Hospital Santosh deemed to be university  Department of pediatric and preventive dentistry, Santosh dental college, Sector 12 Pratap vihar,
Ghaziabad
UTTAR PRADESH 		 07907193209

sreelakshmijayalal98@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ETHICS COMMITTEE SANTOSH DEEMED TO BE UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R00-R99||Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  TRIPLE ANTIBIOTIC PASTE WITH CHITOSAN NANOPARTICLE  The intervention group will receive chitosan nanoparticle as a vehicle for triple antibiotic paste in LSTR, utilizing chitosan’s strong antimicrobial properties and the nanoparticles ability to enhance drug penetration and sustained release. This formulation aims to improve the overall efficacy of lesion sterilisation and tissue repair in primary molars. Intervention period: 1 Year 6 months 
Comparator Agent  TRIPLE ANTIBIOTIC PASTE WITH PROPYLENE GLYCOL  The comparator group will receive triple antibiotic paste with propylene glycol as the vehicle, which is conventionally used in routine LSTR procedures. Propylene glycol facilitates adequate drug dispersion and penetration, serving as a standard reference for evaluating the efficacy of alternative vehicles. 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Clinical features
1.Children aged: 6- 12 years
2. Children with deep caries approximating pulp in primary molars.
3. Presence of gingival abscesses, fistula opening
4. Tooth showing one or more signs and symptoms such as pain, tender to percussion,
mobility (grade I, II)
5. Pulpotomized tooth failure

Radiographical features
1. Furcation, or periapical radiolucency
2. Evidence of pathologic external or internal root resorption with atleast two- thirds of
the root
3. Coronal – deep carious lesion involving or approximating pulp
4. Radicular - discontinuity of lamina dura 
 
ExclusionCriteria 
Details  Clinical features
1. Non restorable tooth
2. Patients with medical problems, systemic diseases or drug allergy
3. Special children with a physical or emotional alteration
4. Caries in primary teeth exhibiting pre-shedding mobility or nearing exfoliation

Radiographical features
1. Evidence of excessive internal or external root resorption involving more than half of
the root
2. Perforated pulpal floor
3. excessive bone loss in furcation area involving underlying tooth germ 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Publication in PubMed/Scopus/Web of Science
• Patent
• Start-up Entrepreneurship potential
• Preliminary study for Extra-mural Grant 		 1. Sample collection/ testing of samples: 1 year
2. Follow up: 0 month,3rd month,6th month
3. Result compilation & Statistical Analysis: 16th month
4. Manuscript Completion: 17th month
5. Publication process start: 18th month
 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="82"
Sample Size from India="82" 
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)   15/08/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sreelakshmijayalal98@gmail.com].

  6. For how long will this data be available start date provided 10-07-2025 and end date provided 31-12-2030?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial aims to evaluate the clinical and radiographic efficacy of chitosan nanoparticles as a vehicle for triple antibiotic paste in lesion sterilisation and tissue repair (LSTR) of primary molars in children aged 6–12 years. Eighty-two subjects will be divided into two equal groups: Group A (control) receiving triple antibiotic paste with propylene glycol, and Group B (intervention) receiving triple antibiotic paste with chitosan nanoparticle gel. Chitosan, known for its antimicrobial properties and enhanced drug delivery potential in nanoparticle form, may improve the effectiveness of LSTR. Follow-up assessments will be conducted at 1, 3, and 6 months post-treatment. 
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