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CTRI Number  CTRI/2025/03/082956 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 20/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   N-Acetyl Cysteine vs. Mineral Trioxide Aggregate in Primary Molar Vital Pulp Therapy: A Randomized Controlled Trial 
Scientific Title of Study   Comparative evaluation of N-acetyl cysteine and Mineral trioxide aggregate (MTA) as pulpotomy medicaments in primary molars: A 12-month follow-up 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  Sanket Vijay Parmalkar 
Designation  Post graduate student  
Affiliation  Pacific Dental College and Hosptial Debari Udaipur 
Address  Room no 9 Department of pediatric and preventive dentistry Pacific Dental college and Hospital Debari Udaipur Udaipur
Room no 9 Department of pediatric and preventive dentistry Pacific Dental college and Hospital Debari Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  9309848378  
Fax    
Email  parmalkarsonu@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dinesh Rao 
Designation  HOD pg guide 
Affiliation  Pacific Dental College and Hosptial Debari Udaipur 
Address  Room no 9 Department of pediatric and preventive dentistry Pacific Dental college and Hospital Debari Udaipur Udaipur
Room no 9 Department of pediatric and preventive dentistry Pacific Dental college and Hospital Debari Udaipur Udaipur
Udaipur
RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dinesh Rao 
Designation  HOD pg guide 
Affiliation  Pacific Dental College and Hosptial Debari Udaipur 
Address  Room no 9 Department of pediatric and preventive dentistry Pacific Dental college and Hospital Debari Udaipur Udaipur
Room no 9 Department of pediatric and preventive dentistry Pacific Dental college and Hospital Debari Udaipur Udaipur

RAJASTHAN
313024
India 
Phone  9414158235  
Fax    
Email  pedodinesh2003@yahoo.co.in  
 
Source of Monetary or Material Support  
Pacific Dental College And Hospital Debari Udaipur 313024 
 
Primary Sponsor  
Name  Sanket Vijay Parmalkar 
Address  Pacific Dental College And Hospital Debari Udaipur 313024 
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 sanket vijay parmalkar  Pacific Dental College And Hospital Debari Udaipur 313024  Department of pediatric and preventive dentistry first floor room number nine Pacific Dental College And Hospital Debari Udaipur 313024
Udaipur
RAJASTHAN 
9309848378

parmalkarsonu@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional research review board (Pacific dental college and hospital debari udaipur) 313024 rajasthan   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  MTA (Mineral trioxide aggregate)  pulpotomy of primary molars using MTA (Mineral trioxide aggregate) MTA is less cytotoxic compared to traditional materials like formocresol, reducing the risk of adverse reactions 
Intervention  N acetyl cysteine  Pulpotomy in primary molars using N acetyl cysteine N-Acetyl Cysteine (NAC) is known for its antioxidant properties and has been explored in various medical applications 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  patient aged 5-12 years, Deep Carious/mechenical exposure in vital asymptomatic tooth, Tooth free of radicular pulpitis, Presence of atleast 2/3rd of root length 
 
ExclusionCriteria 
Details  Presence of absecess,fistula or swelling, Presence of interradicular bone loss, Presence of internal root resorption, Presence of necroyic pulp, Tooth close to natural exfoliation, Mobility of tooth, Pain on percussion  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
N acetyl cysteine will show better or equal results as compared to MTA when used as a pulpotomy agent   Evaluation will be done at 3 months, 6 months and 12 months respectively 
 
Secondary Outcome  
Outcome  TimePoints 
N acetyl cysteine preserves the vitality of remaining radicular pulp, prevents root resorption and has better bactericidal effect as compared to MTA   Evaluation will be done at 3 months, 6 months and 12 months respectively 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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 4 
Date of First Enrollment (India)   31/03/2025 
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 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 - NO
Brief Summary  

Pulpotomy is widely used for treatment of primary tooth to maintain its integrity until normal exfoliation. An ideal pulpotomy material should have appropriate sealing ability, bio-inductivity, biocompatibility, and have the ability to eliminate bacteria and preserve healthy radicular pulp and promote its healing. However, none of the available and recommended medicaments for pulp therapy present all these properties.Although Formocresol (FC) has long been considered to be the gold standard, researchers are questioning its use in pulpotomy because of possible mutagenic and toxic effects. Different materials such as calcium hydroxide, ferric sulfate, and glutaraldehyde have been suggested as an alternative for FC.Numerous medicaments with various protocols that retain radicular pulp vitality from time to time since the success of pulpotomy relies on medicament used. Owing to intricacies of earlier medicaments, the thrive for better drug made clinicians eye toward regenerative materials in the recent past. Mineral trioxide aggregate (MTA) is one such regenerative material recognized as the reference material for conservative pulp vitality treatments in primary teeth, with high pulpotomy success rates (90%–100%) in clinical, radiographic, and histopathologic studies.

 

N-acetylcysteine (NAC) is a membrane-permeable aminothiol compound with diverse functions. NAC is shown to be the precursor of GSH with a significant antioxidant effect.NAC has also been regarded as an anti-inflammatory compound. Therefore, NAC is shown to have a number of different functions depending on the nature of the cells and their stage of maturation. However, it seems one of the primary functions of NAC is inhibition of cell death. At present it is unclear how NAC protects the cells from cell death. However, previous work has attributed the protective effect of NAC in HEMA- and TEGDMA-mediated cell death to its antioxidant effects.

 

Few studies have reported that the n acetyl l cysteine inhibits cell death due to its antioxidant effect. No study have been reported which uses N acetyl l cysteine as pulpotomy agent in primary teeth. The motivation behind the study is to evaluate the efficacy of N acetyl l cysteine when used for pulpotomy of primary teeth.Thus this randomised clinical study will be used to evaluate the efficacy of N acetyl l cysteine in pulpotomy of primary molars, among children aged between 5-12 yrs.

The study is based on the hypopthesis that both the N acetyl l cysteine can be used as an alternative material in pulpotomy of primary teeth.

 

 
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