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
|
|
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
|
|
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. |