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CTRI Number  CTRI/2017/11/010379 [Registered on: 06/11/2017] Trial Registered Prospectively
Last Modified On: 26/02/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Treatment of deep cavity in the tooth 
Scientific Title of Study   Evaluation of a calcium hydroxide liner and two tricalcium silicate cements as indirect pulp capping agents: prospective randomized control single blind trial 
Trial Acronym  IPC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal University 
Address  Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal University
"ANAGHA", Rabindranath Tagore Road, Kunjebetteu, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9880626167  
Fax    
Email  drballal@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal University 
Address  Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal University
"ANAGHA", Rabindranath Tagore Road, Kunjebetteu, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9880626167  
Fax    
Email  drballal@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Vasudev Ballal 
Designation  Professor 
Affiliation  Manipal College of Dental Sciences, Manipal University 
Address  Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal, Manipal University
"ANAGHA", Rabindranath Tagore Road, Kunjebetteu, Udupi
Udupi
KARNATAKA
576104
India 
Phone  9880626167  
Fax    
Email  drballal@yahoo.com  
 
Source of Monetary or Material Support  
Medcem GmbH, Weinfelden, Switzerland 
 
Primary Sponsor  
Name  Medcem 
Address  Medcem GmbH, Weinfelden, Switzerland 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Department of Conservative Dentistry and Endodontics  Manipal College of Dental Sciences, Manipal, Manipal University, Karnataka 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vasudev Ballal  Manipal College of Dental Sciences  Department of Conservative Dentistry and Endodontics, Manipal
Udupi
KARNATAKA 		 9880626167

drballal@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC-KH ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients having deep caries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dycal  Calcium hydroxide will be used as a comparator agent 
Intervention  MTA and Biodentine  MTA and Biodentine cement will be used as intervention groups 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1) Posterior teeth with caries on the occlusal or proximal surfaces that on bitewing radiographs extends more than half way through the dentine towards the pulp but not reaching pulp;
2) Teeth with pulps diagnosed as saveable (with reversible inflammation);
3) Teeth with pulps that give a positive response to cold and electric pulp testing;
4) Teeth with sound periodontium (absence of bleeding on probing, sulcus depth £ 3 mm; no loss of attachment);
5) Teeth with no apical pathosis on periapical radiographs;
6) Patients 18 years of age or above and willing/able to give consent.

 
 
ExclusionCriteria 
Details  1) Teeth with irreverisbly inflamed pulps with sharp spontaneous pain (on sitting or lying down) and provoked pulpal pain;
2) Teeth with abnormnal responses to cold and electric pulp tests;
3) Teeth with radiographic evidence of complete calcification/obliteration of pulp chamber and root canal;
4) Teeth with necrotic pulps;
5) Teeth with an associated swelling or sinus tract;
6) Caries involving the pulp on bitewing radiographs;
7) Signs of apical pathosis on periapcial radiographs, such as a widened periodontal ligament space, periapical or furcal radiolucency, or internal or external root resorption;
8)Teeth with pathologic mobility.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Survival of capped pulps  4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Association between the three materials and preoperative and postoperative symptoms   2 years 
 
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 4 
Date of First Enrollment (India)   14/11/2017 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This trial evaluates for the efficacy of MTA, Biodentine and calcium hydroxide as indirect pulp capping agents in patients with deep caries. 
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