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CTRI Number  CTRI/2025/02/080136 [Registered on: 07/02/2025] Trial Registered Prospectively
Last Modified On: 03/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of different pulpotomy agents used in Primary molars 
Scientific Title of Study   A Comparative clinico-radiographic evaluation of efficacy of different pulpotomy agents used in Primary molars - A Randomised Controlled 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  Dr Akanksha Sirohi 
Designation  Post graduate student 
Affiliation  Subharti dental college and hospital 
Address  Room no.3, First floor, Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital, Swami Vivekanand Subharti University

Meerut
UTTAR PRADESH
250005
India 
Phone  9717961084  
Fax    
Email  dr.akanksha2201@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Noopur Kaushik 
Designation  Professor, Department of Pediatric and Preventive Dentistry 
Affiliation  Subharti dental college and hospital 
Address  Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital,Swami Vivekanand Subharti University

Meerut
UTTAR PRADESH
250005
India 
Phone  7830008899  
Fax    
Email  drnoopurkaushik@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Noopur Kaushik 
Designation  Professor, Department of Pediatric and Preventive Dentistry 
Affiliation  Subharti dental college and hospital 
Address  Department of Pediatric and Preventive Dentistry, Subharti dental college and hospital,Swami Vivekanand Subharti University

Meerut
UTTAR PRADESH
250005
India 
Phone  7830008899  
Fax    
Email  drnoopurkaushik@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatric and Preventive Dentistry,Subharti dental college and hospital, Swami Vivekanand Subharti University,NH58, Delhi-Haridwar Bypass road, Meerut, Uttarpradesh, India PIN code- 250005 
 
Primary Sponsor  
Name  Dr Akanksha Sirohi 
Address  Room no. 3, First floor, Department of Pediatric and Preventive dentistry, Subharti dental college and hospital,Swami Vivekanand Subharti University, NH58, Delhi Haridwar bypass road, Meerut, Uttarpradesh, India PIN code-250005 
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 Akanksha Sirohi  Subharti dental college and hospital  Room no. 3, First floor, Department of Pediatric and Preventive dentistry
Meerut
UTTAR PRADESH 
9717961084

dr.akanksha2201@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
University Ethics Committee (Medical) Swami Vivekanand Subharti University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Patient requiring vital pulpal therapy (pulpotomy) with stainless steel crown 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biodentine as pulpotomy agent on primary teeth (Group III)  After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis. 1.5-2 mm thick layer of Biodentine cement is placed in the pulp chamber. After placing zinc oxide eugenol base, pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. 
Intervention  Emdogain as pulpotomy agent on primary teeth (Group IV)  After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis. A single drop of Emdogain is placed in the pulp chamber. After placing zinc oxide eugenol base pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. 
Comparator Agent  Laser as pulpotomy agent on primary teeth (Group I)  After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis. Then Diode laser beam of 980 nm wavelength, 3W power is projected in continuous pulse mode for 2-3 minutes at one spot. After placing zinc oxide eugenol base pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. 
Intervention  MTA putty as pulpotomy agent on primary teeth (Group II)  After anaesthetising the tooth, Access opening will be done. The coronal pulp will be removed, sterile moist cotton pellets applied to pulp stumps for 5 min to achieve hemostasis. 2mm thick layer of premixed MTA is dispensed into the pulp chamber via MTA syringe. After placing zinc oxide eugenol base pulpotomised teeth will be restored with GIC cement followed by stainless steel crown. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  1. Cooperative healthy pediatric patient aged 4-10 years
2. Presence of carious primary molar/ traumatic exposure / mechanical exposure during caries excavation
3. Restorable crown structure present
4. Presence of atleast 2/3rd root length
5. Bright red hemorrhage from exposure sites that can be controlled during pulpotomy procedure
6. No interradicular bone loss and radiolucency 
 
ExclusionCriteria 
Details  1. Uncooperative patient
2. Medically compromised children
3. Teeth with clinical sign and symptoms of pulpal exposure with persistent pain
4. Primary teeth with root resorption more than 2/3rd of the root length
5. A non restorable teeth
6. Teeth with radiographic sign and symptoms of pulp degeneration,
pathologic mobility, swelling or/and fistula, external or internal
resorption and calcification of pulp 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth.  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Evaluate Occasional pain, Sensitivity (TOP), Fistula, Pathological mobility; Radiolucency at furcation, Internal/ external resorption, and Calcification in pulpotomised tooth.  3, 6, 9 months 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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 3 
Date of First Enrollment (India)   15/02/2025 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
Preserving primary teeth is a key goal in pediatric dentistry, especially in the context of Early Childhood Caries (ECC) and Traumatic Dental Injuries (TDI), both of which are prevalent globally, including in India. ECC affects 49.6% of children in India, while TDI occurs in 13% of children, with higher rates in those under 6 years old. If untreated, both conditions can lead to early pulp exposure, necessitating costly and complex treatments like endodontic therapy.

To manage pulp exposure, techniques like pulpotomy are commonly used. Pulpotomy involves removing the coronal pulp to preserve the vitality of the root portion, typically in cases of extensive caries or trauma without radicular pathology. Over the years, various materials have been used for pulpotomy, including formocresol, zinc oxide eugenol (ZOE), mineral trioxide aggregate (MTA), biodentine (BD), enamel matrix derivative (Emdogain), and laser therapy.

Formocresol was historically used but is no longer recommended due to its toxicity. Alternatives like MTA and BD are popular due to their biocompatibility, sealing ability, and favorable clinical outcomes. BD, in particular, offers advantages like quick setting time and ease of handling over MTA. Emdogain, a newer material, shows promise in regenerating tooth tissues and enhancing periodontal attachment, though research is limited.

Lasers, specifically diode lasers, are also being explored for pulpotomy, as they allow precise tissue removal with minimal impact on surrounding dental structures. Despite the variety of materials and techniques, few studies have directly compared their clinical and radiographic success, making this area an important focus for future research.
 
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