| 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
|
|
|
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
|
|
|
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. |