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CTRI Number  CTRI/2020/12/029578 [Registered on: 04/12/2020] Trial Registered Prospectively
Last Modified On: 01/12/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   evaluation of three different materials as base under restoration in deeply carious milk teeth clinically and radiographically 
Scientific Title of Study   Clinical and Radiographic Evaluation of Efficacy of MTA, Biodentine, & Silver Diamine Fluoride as Indirect Pulp Capping Materials in Primary Molars. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Durga R 
Designation  jr 2 
Affiliation  Faculty of Dental Sciences, Lucknow 
Address  dept of paediatric and preventive dentistry, fourth floor, new dental opd, Kgmu, Lucknow
Kgmu, Lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  08939226879  
Fax    
Email  rdurgabds@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Durga R 
Designation  jr 2 
Affiliation  Faculty of Dental Sciences, Lucknow 
Address  dept of paediatric and preventive dentistry, fourth floor, new dental opd, Kgmu, Lucknow
Kgmu, Lucknow

UTTAR PRADESH
226003
India 
Phone  08939226879  
Fax    
Email  rdurgabds@gmail.com  
 
Details of Contact Person
Public Query  
Name  dr Rajeev Kumar Singh 
Designation  Professor 
Affiliation  faculty of dental sciences, lucknow 
Address  dept of paediatric and preventive dentistry, fourth floor, new dental opd, Kgmu, Lucknow
kgmu, lucknow
Lucknow
UTTAR PRADESH
226003
India 
Phone  9450849528  
Fax    
Email  rajkids2000@yahoo.co.in  
 
Source of Monetary or Material Support  
faculty of dental sciences, king george medical university, lucknow 
 
Primary Sponsor  
Name  dr durga r 
Address  dept of peadiatric and preventive dentistry, 4th floor, new dental opd, F.O.D.S., K.G.M.U., LUCKNOW  
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 
r durga  king georges medical university  4th floor, new dental building, department of pediatric and preventive dentistry, faculty of dental sciences, Kgmu, Lucknow
Lucknow
UTTAR PRADESH 		 8939226879

rdurgabds@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, King George’s Medical University, Lucknow, U.P.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  healthy children aged between 4 to 10 years who are indicated for dental indirect pulp capping treatment 
Patients  (1) ICD-10 Condition: K029||Dental caries, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Biodentine, silver diamine fluoride.  clinical and radiographic evaluation of Mineral trioxide aggregate, biodentine, and Silver diamine fluoride as indirect pulp capping agent underneth the definitive restoration, and studied for thickness and quality of dentine formed after 6 months.  
Comparator Agent  mineral trioxide aggregate  clinical and radiographic evaluation of three different pulp capping agents, mineral trioxide aggregate agent, biodentine and silver diamine fluoride as indirect pulp capping agent underneth the definitive restoration.  
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  10.00 Year(s)
Gender  Both 
Details  Clinically
1)Children between the age group of 4 to 10 years.
2)Teeth with deep caries on the occlusal or proximal surfaces with history of dull reversible pain or mild discomfort on chewing
3)Sensitivity to hot, cold, and sweet lasting not more than 15 to 20 sec.

Radiographically
1)Caries depth greater than two-third of dentine thickness approaching pulp
2)No radiolucency in periapical or furcational area of teeth
 
 
ExclusionCriteria 
Details  1)Teeth with periodontal lesions/ Pathological mobility
2)Teeth near to exfoliation
3)Non restorable teeth
4)Teeth more than half root resorption
5)Dull throbbing pain, sharp spontaneous pain, or pain exacerbated by lying down
6)Sensitivity to palpation or percussion
7)Discolored teeth
8)Radiolucency in periapical and/or furcation area of teeth
9)Un- cooperative patients who cannot be managed by non-pharmocological behavior management techniques.
 
 
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 
variation in dentin depth at post op. and 6 month time in the standard group out of the three study groups.  8 weeks, 6 months, 1 year. 
 
Secondary Outcome  
Outcome  TimePoints 
clinical and radiographic success rate of the three different pulp capping agents in three grops based on the evaluation crieteria   at 8th week, 6 month and 1 year follow-up 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/12/2020 
Date of Study Completion (India) 17/09/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

INTRODUCTION

Indirect pulp treatment (IPT) or indirect pulp capping (IPC) is recommended for teeth that have deep carious lesions approximating the pulp with no signs or symptoms of pulp degeneration. This technique has been derived with the ideology that the dental pulp possesses the ability to form a dentin-like matrix (tertiary dentin) as a part of the repair in the dentin-pulp complex. Calcium hydroxide has been a gold standard for pulp capping. Various disadvantages have been witnessed with calcium hydroxide when followed up for longer times which has led to the use of various materials for IPC including glass ionomer cement and adhesives and more recently mineral trioxide aggregate (MTA), and biodentine.

AIM AND OBJECTIVE:

1.     To assess and compare, the success rate of indirect pulp treatment in primary teeth using mineral trioxide aggregate (MTA), Biodentine, silver diamine fluoride (SDF) as capping agents clinically.

2.     To determine and compare the radiological changes in terms of quantity and quality of tissue formed under these capping materials in primary teeth

 

MATERIAL AND METHOD:

In a randomized control trail, 60 patients aged between 4-10 years, will be randomly allocated in three groups, group 1- MTA, group 2- Biodentine, and group 3- silver diamine fluoride. Procedure involves satisfactory removal of infected dentine, then one of the test material will be applied at the base of the cavity, and definitive restoration (closed sandwich technique) will be done on the same day. An immediate Postoperative Cone Beam Computer Tomography scan will be performed on the same day for baseline data. Standard procedural protocol shall be followed for isolation, technique, and material manipulation. Patient will not be allowed to eat for 1 hours postoperative. Each tooth will be followed up at 8 weeks, 6 month, 12 month for observation of clinical outcome and radiographical changes in thickness and type of dentine formed beneath the test material. To identify the thickness and type of dentine another CBCT will be performed at 6th month follow up visit. At the end of the study, the data obtained from all the groups will be summarized collectively and subjected to statistical analysis.

 
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