CTRI

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CTRI Number

CTRI/2020/04/024428 [Registered on: 01/04/2020] Trial Registered Prospectively

Last Modified On:

27/03/2020

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Dentistry

Study Design

Randomized, Parallel Group Trial

Public Title of Study

A study to compare the how long the cement material retains in primary molars

Scientific Title of Study

Evaluation of clinical performance of carious primary molars restored with Bioactive restorative material and Resin modified Glass ionomer cement.

Trial Acronym

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr K Bhavana
Designation	Post graduate student
Affiliation	Vishnu dental college
Address	Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 West Godavari ANDHRA PRADESH 534202 India
Phone	9912511125
Fax	08816250894
Email	bhavanapinky93@gmail.com

Details of Contact Person
Scientific Query

Name	Dr A Ratnaditya
Designation	Reader
Affiliation	Vishnu dental college
Address	Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 West Godavari ANDHRA PRADESH 534202 India
Phone	9885394144
Fax	08816250894
Email	adityahospital3@gmail.com

Details of Contact Person
Public Query

Name	Dr Vinay C
Designation	Professor
Affiliation	Vishnu dental college
Address	Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 West Godavari ANDHRA PRADESH 534202 India
Phone	9666404455
Fax	08816250894
Email	vinaychandrappa@yahoo.co.in

Source of Monetary or Material Support

Vishnu dental college vishnupur bhimavaram 534202

Primary Sponsor

Name	Dr K Bhavana
Address	Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202
Type of Sponsor	Other [Post graduate student]

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 K Bhavana	Vishnu dental college	Room no.5 Department of Pedodontics and Preventive Dentistry Vishnu dental college Vishnupur Bhimavaram-534202 West Godavari ANDHRA PRADESH	9912511125 08816250894 bhavanapinky93@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
VISHNU INSTITUTIONAL ETHICAL COMMITTEE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K029\|\|Dental caries, unspecified,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Activa kids Bioactive restorative material	Patented Bioactive ionic resin Patented rubberized resin Reactive glass ionomer dual cure restorative material and an enhanced resin modified glass ionomer with bioactivity
Comparator Agent	Resin Modified Glass Ionomer Cement	powder and liquid system of RMGIC

Inclusion Criteria

Age From	5.00 Year(s)
Age To	8.00 Year(s)
Gender	Both
Details	Contra-lateral matched pair of primary molars with distinct occlusal cavity with visible dentin (ICDAS II score 5) in children of 5-8 year old. Co-operative children. Children available for 6,12,18 month follow up.

ExclusionCriteria

Details

Medically compromised patients.
Children without consent.
Teeth with enamel defects.
Children participating in other studies.

Method of Generating Random Sequence

Coin toss, Lottery, toss of dice, shuffling cards etc

Method of Concealment

An Open list of random numbers

Blinding/Masking

Participant and Outcome Assessor Blinded

Primary Outcome

Outcome	TimePoints
The study outcome measures are quantified using USPHS (United State Public Health Service) RETENTION.	6, 12,18 month follow period

Secondary Outcome

Outcome	TimePoints
The study outcome measures are quantified using USPHS (United State Public Health Service) Surface texture and Marginal discoloration	6 month 12 month 18 month interval

Target Sample Size

Total Sample Size="100"
Sample Size from India="100"
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

N/A

Date of First Enrollment (India)

01/04/2020

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="6"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

Nil

Individual Participant Data (IPD) Sharing Statement

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

Brief Summary

ACTIVA being a new Bioactive restorative material, clinical trials pertaining to the performance of the material are lacking. Research in this area to generate the necessary evidence is required. Hence the present study aims to evaluate the clinical performance of Bioactive restorative material and Resin modified glass ionomer cement for restoring occlusal carious lesions in primary molars of 5-8 years aged children. It is randomized split mouth ,trial to evaluate the clinical performance of Surface texture, Retention, Marginal discoloration of restorations at 6,12,18 month interval using modified USPHS (United State Public Health Service) criteria.