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CTRI Number  CTRI/2025/08/093121 [Registered on: 14/08/2025] Trial Registered Prospectively
Last Modified On: 13/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparison of efficacy of different pulp capping agent on human teeth  
Scientific Title of Study   Comparative evaluation of MTA, combination of Chitosan-Nanohydroxyapatite and combination of Chitosan -Nanohydroxyapatite -Collagen on formation of dentinal bridge and inflammatory response of pulp when used as a direct pulp capping agent on human teeth. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Mrunal Shinde 
Designation  Assistnt Professor 
Affiliation  bharati vidyapeeth deemed to be university dental college and hospital ,pune. 
Address  J 1105, Asawari building, nanded city singhgad road, pune
bharati vidyapeeth deemed to be university dental college and hospital ,katraj,dhankwadi, pune.
Pune
MAHARASHTRA
411041
India 
Phone  9921917979  
Fax    
Email  mrunal.shinde@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Varsha Pandit (MDS,PhD) 
Designation  Associate Professor and PhD guide 
Affiliation  bharati vidyapeeth deemed to be university dental college and hospital ,pune. 
Address  Plot no.13,shrihari society ,shreedharnagar,dhankawadi,pune-43
bharati vidyapeeth deemed to be university dental college and hospital ,katraj,dhankwadi, pune.
Pune
MAHARASHTRA
411043
India 
Phone  9850601530  
Fax    
Email  varsha.pandit@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Dr Mrunal Shinde 
Designation  Assistnt Professor 
Affiliation  bharati vidyapeeth deemed to be university dental college and hospital ,pune. 
Address  J 1105, Asawari building, nanded city singhgad road, pune
bharati vidyapeeth deemed to be university dental college and hospital ,katraj,dhankwadi, pune.

MAHARASHTRA
411041
India 
Phone  9921917979  
Fax    
Email  mrunal.shinde@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed to be University Dental College and Hospital, Dhank wadi, Pune-Satara Road, Pune, Maharasthra, India 411043 
 
Primary Sponsor  
Name  Dr mrunal shind 
Address  J 1105,ASAWARI BUILDING,NANDED CITY, SINGHGAD ROAD,PUNE 
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 Mrunal Shinde  Bharati Vidyapeeth Deemed University Dental College and Hospital ,Pune  Department number 101, first floor, Department of conservative Dentistry and Endodontics.
Pune
MAHARASHTRA 		 9921917979

mrunal.shinde@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed University Dental College and Hospital ,Pune  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy human opting for routine orthodontic treatment and secduled for extraction of premolars for the same  
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Combination of chitosan and nanohydroxyapatite   not applicable  
Intervention  Combination of Chitosan, Nanohydroxyapatite and Collagen   not applicable  
Comparator Agent  Mineral trioxide aggregate (MTA)  MTA is a Gold standard for pulp capping agent.  
 
Inclusion Criteria  
Age From  15.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  Pt. between age group of 15 to 25 years will be seleted from Dept. of orthodontic and dentofacial orthopedics ,bhararti vidyapeeth demeed university dental college and hospital,pune.
Inclusion citeria:
1) Sound permanent premolar with closed apces
2)No carious lesion
3)Normal response to pulp vitality test
 
 
ExclusionCriteria 
Details  1) Fracture teth 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Asymptomatic vital permanent teeth with exposed pulp can be treated successfully by direct pulp capping using combination of chitosan-nanohydroxyapetite-collagen thereby allowing patient to retained teeth longer and at lower cost than alternative more invasive intervention like Root Canal Treatment.  sample will be assessed histopathologically under research microscope at 5th,28th and on 90th day. 
 
Secondary Outcome  
Outcome  TimePoints 
Repair progress of pulp tissue will be assessed by checking i)dentinal bridge formation ii)inflammatory response after using different direct pulp capping material at different time interval.   1)Good dentinal bridge will formed at 28 th day
2)Inflammatory response of pulp tissue will be present at 5 th day,
Reduced inflammatory response of pulp tissue at 28 th day,
Inflammatory response of pulp tissue will be absent at 90 th day.
 
 
Target Sample Size   Total Sample Size="54"
Sample Size from India="54" 
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)   24/09/2025 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary    -This is comparative evaluation of three pulp capping agent 1) Mineral trioxide aggregate (MTA) control , 2) Combination of Chitosan and Nanohydroxyapatite,3) Combination of Chitosan ,Nanohydroxyapatite and Collagen. 
-Efficacy of each material checked by following  criteria :
 a) Quality and quantity of newly formed dentinal bridge b) Inflammatory response of pulp to Pulp capping material. 
-Expected outcome :Better quality of newly formed dentinal bridge and gradual reduction in inflammatory response at 28th day and absence of pulp inflammation at 90th day will be consider as better pulp capping agent.

 
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