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CTRI Number  CTRI/2025/01/079476 [Registered on: 24/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical comparison of three dental materials on dental pulp tissue 
Scientific Title of Study   To compare the efficacy of new light cure MTA with existing bioceramics in management of exposed dental pulp tissue: A randomized control 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  Dr SRINIVASA T S 
Designation  PROFESSOR & HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCESGORAKHPUR 
Address  ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES KUNRAGHAT GORAKHPUR
ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES KUNRAGHAT GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9993519183  
Fax    
Email  seen79@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr SRINIVASA T S 
Designation  PROFESSOR & HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
Address  ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES KUNRAGHAT GORAKHPUR
ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES KUNRAGHAT GORAKHPUR
Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9993519183  
Fax    
Email  seen79@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srinivasa T S 
Designation  PROFESSOR & HOD 
Affiliation  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
Address  ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES KUNRAGHAT GORAKHPUR

Gorakhpur
UTTAR PRADESH
273008
India 
Phone  9993519183  
Fax    
Email  seen79@rediffmail.com  
 
Source of Monetary or Material Support  
ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR 
 
Primary Sponsor  
Name  Dr Srinivasa T S 
Address  ROOM NO 7 DEPT OF DENTISTRY ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR KUNRAGHAT GORAKHPUR 
Type of Sponsor  Other [SELF FUNDED] 
 
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 Srinivasa T S  ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR  OPD Room no 7, Dept of Dentistry
Gorakhpur
UTTAR PRADESH 
9993519183

seen79@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE AIIMS GORAKHPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K040||Pulpitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Biodentine  Mix for 30 seconds and place the biodentine mixture on the exposed dental pulp tissue with a sterilized appropriate instrument. Restore with appropriate restorative material. 
Intervention  Light cure Mineral trioxide aggregate  Application of Dentigrate Light cure MTA on the pulp exposure using a small applicator and light cure for 1 minute. After setting of MTA, restore with appropriate restorative material. 
Intervention  Mineral Trioxide Aggregate(powder liquid form)  Mix the powder and liquid MTA for 30 seconds the and place the cement on the exposed dental pulp tissue with an appropriate instrument. Restore with appropriate restorative material. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1 Tooth with deep caries
2 Permanent 1st and 2nd molar
3 Carious exposure 0.5mm to 2mm
4 Tooth with diagnosis of reversible pulpitis
5 Positive pulp response.
 
 
ExclusionCriteria 
Details  1 Presence of crowns, removable partial dentures,
2 Patient with history of orthodontic treatment,
3 Patient with open bite malocclusion
4 Primary teeth
5 Teeth with irreversible pulpitis/ pulp necrosis/ presence of periapical lesion
6 Tooth with periodontal disease, calcified canal, internal or external resorption
7 Pulpal bleeding that could not be controlled within 10 minutes
8 Patient with tumor(s) of the soft or hard tissues of the oral cavity
9 Any developmental disorders
10.Congenital defect of tooth, 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Primary outcome will be clinical and radiographic success rates at the 1,3, 6 and 12 months follow up  1,3, 6, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
postoperative pain   7 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   10/02/2025 
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="0"
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  

Direct exposure of the pulp to the oral environment breaks the integrity of the pulp-dentin complex, if not treated properly, will lead to apical periodontitis, which eventually requires root canal treatment or extraction. The treatment widely practiced for exposed dental pulp is considered root canal treatment as healing of the pulp tissue is unpredictable. Direct pulp capping has been described as a method that utilizes regenerative capacity of human dental pulp cells. The procedure of pulp capping relies primarily on the ability of pulpal tissue to heal and its ability to form hard tissue barriers called reparative dentin.  Pulp capping material should provide a suitable condition to encourage regeneration of the dentin-pulp complex which will induce differentiation of odontoblast like cells, be antibacterial, biocompatible, and nontoxic.

Calcium hydroxide introduced in 1930 by Herman was considered gold standard for the treatment of direct pulp exposure by reparative dentine formation and strong antibacterial property. Drawbacks such as high solubility, low mechanical resistance and lack of bond to dentine often lead to tunnel defect formation with use of calcium hydroxide. [2] Many formulations have been proposed to overcome the drawback of calcium hydroxide such as resin infiltrate glass ionomer, calcium phosphate, bio-silicates material such as MTA and Biodentine, light cure tricalcium silicate cement.

Biodentine have high mechanical properties, excellent biocompatibility and bioactive behavior. Due to its good sealing ability with dentin, it is used as a dentin replacement material as pulp protection, temporary restoration, cervical filling, direct and pulp capping and pulpotomy.

Currently MTA introduced by Torabinejad in 1990 has gain popularity as a material of choice for direct pulp capping. The success rates of direct pulp capping were reported to range from 67.4% at 3 years and 97.96% after a 9-year follow-up for MTA. MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakage. 
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