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CTRI Number  CTRI/2015/05/005746 [Registered on: 05/05/2015] Trial Registered Retrospectively
Last Modified On: 01/05/2015
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of drug loaded polymer fibers in patients with deep dental caries in primary teeth 
Scientific Title of Study   A randomized controlled trial of Chlorhexidine impregnated polymer fibers and mineral trioxide aggregate as pulpotomy agents in primary molars 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
U1111-1167-1038  UTN 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K S D Ravi kalyan 
Designation  Senior resident 
Affiliation  Vishnu Dental College 
Address  Dept Of Pediatric Dentistry Vishnu dental college Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India 
Phone  08816250893  
Fax    
Email  dr.ravikalyan@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Vinay Chandrappa 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Dept Of Pediatric Dentistry Vishnu dental college Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India 
Phone  08816250893  
Fax    
Email  vinaychandrappa@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Arun Bhupathi P 
Designation  Assistant Professor 
Affiliation  Vishnu Dental College 
Address  Dept Of Pediatric Dentistry Vishnu dental college Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
Vishnu dental college Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
West Godavari
ANDHRA PRADESH
534202
India 
Phone  08816250893  
Fax    
Email  arunbhupathi.p@vdc.edu.in  
 
Source of Monetary or Material Support  
Vishnu Dental College Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh  
 
Primary Sponsor  
Name  Vishnu Dental College 
Address  Vishnu Dental College Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh  
Type of Sponsor  Other [Private Dental College] 
 
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 Ravi Kalyan  Vishnu Dental College  Vishnu dental college Vishnupur Bhimavaram 534202 West Godavari District Andhra Pradesh
West Godavari
ANDHRA PRADESH 
08816250893

dr.ravikalyan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Deep dental caries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Chlorhexidine gluconate loaded polymer fibers  2% Chlorhexidine gluconate loaded polyvinyl alcohol fibers membrane will be placed locally over the dental radicular pulp at the time of pulpotomy procedure. This is a single step procedure, performed only once to maintain the vitality of residual dental radicular pulp. 
Comparator Agent  Mineral trioxide aggregate MTA  Mineral trioxide aggregate (Trade name-Angelus White MTA) will be placed locally over the dental radicular pulp during the single visit pulpotomy procedure. The material is left intact with no further intervention, to maintain the vitality of the residual radicular pulp. 
 
Inclusion Criteria  
Age From  4.00 Year(s)
Age To  6.00 Year(s)
Gender  Both 
Details  Primary teeth with clinical signs of deep dental caries involving enamel, dentin approaching pulp and with short duration of spontaneous dental pain 
 
ExclusionCriteria 
Details  Any tooth which exhibits signs and symptoms of pain, tenderness, chronic infection, fistula, soft tissue swelling, pathological bone loss, pathological root resorption, pathological tooth mobility 
 
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 and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 

Reduction of clinical signs of inflammation,

Preservation of vitality of the tooth

 

7-14days and 3 weeks

 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical signs of secondary infection,
Radiological evaluation of root and alveolar bone resorption
 
24-72hrs and 7days 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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 2 
Date of First Enrollment (India)   03/01/2013 
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)   Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study is randomized double blinded parallel group trial comparing the efficacy of Chlorhexidine gluconate loaded polymer fibers and mineral trioxide aggregate (MTA) as pulpotomy agent in 40 deciduous molars with deep dental caries was conducted in Vishnu dental College, Bhimavaram, India. The primary outcome measures were reduction of clinical signs of inflammation at 7-14days and preservation of vitality of the tooth at 3 weeks. The secondary outcomes were no clinical signs of secondary infection at 24-72hrs and 7days and on radiological evaluation no signs of root and alveolar bone resorption at 4 weeks.

 
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