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CTRI Number  CTRI/2018/03/012415 [Registered on: 07/03/2018] Trial Registered Retrospectively
Last Modified On: 05/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To check the retention of high- cost and low-cost glass ionomer cements used with atraumatic restorative technique in primary teeth. 
Scientific Title of Study   Assessment of retention ability of low-cost and high-cost glass ionomer cements as ART restorative material in deciduous molars: a randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Pragathi D S 
Designation  Post graduate student 
Affiliation  Bangalore Institute of Dental Sciences and Hospital and Post graduate Research Centre 
Address  BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL, Department of Public Health Dentistry, room no 8, 5/3, HOSUR MAIN ROAD, LAKKASANDRA, BANGALORE

Bangalore
KARNATAKA
560027
India 
Phone  9483993999  
Fax  9483993999  
Email  pragathircr@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Chaithra V 
Designation  Reader 
Affiliation  Bangalore Institute of Dental Sciences and Hospital and Post graduate Research Centre 
Address  BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL, Department of Public Health Dentistry, room no 8, 5/3, HOSUR MAIN ROAD, LAKKASANDRA, BANGALORE

Bangalore
KARNATAKA
560027
India 
Phone  9886145047  
Fax  9483993999  
Email  chaithu1949@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Pragathi D S 
Designation  Post graduate student 
Affiliation  Bangalore Institute of Dental Sciences and Hospital and Post graduate Research Centre 
Address  BANGALORE INSTITUTE OF DENTAL SCIENCES AND HOSPITAL, Department of Public Health Dentistry, room no 8, 5/3, HOSUR MAIN ROAD, LAKKASANDRA, BANGALORE

Bangalore
KARNATAKA
560027
India 
Phone  9483993999  
Fax  9483993999  
Email  pragathircr@gmail.com  
 
Source of Monetary or Material Support  
Bangalore Institute of Dental Sciences and Hospital and Post graduate Research Centre, Department of Public Health Dentistry, room no 8, 5/3, Hosur road, Lakkasandra, Bangalore - 560027 
 
Primary Sponsor  
Name  Pragathi D S  
Address  Bangalore Institute of Dental Sciences and Hospital and Post graduate Research Centre, Department of Public Health Dentistry, room no 8, 5/3, Lakkasandra, Hosur road, Bangalore- 560027 
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 
Dr Pragathi D S  Bangalore Institute of Dental Sciences and Hospital  Ground floor, Room no 8, Department of Public Health Dentistry, Bangalore Institute of Dental Sciences, 5/3 Lakkasandra, Hosur main road, Bangalore 560027
Bangalore
KARNATAKA 
9483993999

pragathircr@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board of Bangalore Institute of Dental Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  no harm recorded 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  High-cost glass ionomer cement  used for Atraumatic Restorative Treatment for 5-7 year old school children for a period of 12months 
Comparator Agent  Low-cost glass ionomer cement  used for Atraumatic Restorative Treatment for 5-7 old school children for a period of 12months 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  7.00 Year(s)
Gender  Both 
Details  1. Children aged 5-7years who were willing to participate and whose parents gave consent for the operative procedures were included in the study.
2. Presence of at least two occlusal carious lesions present bilaterally or contra laterally in deciduous molars extending into the dentin.
3. The cavity entrance should be at least 1mm, which permits access for the smallest spoon excavator.  
 
ExclusionCriteria 
Details  1. Children aged 5-7 years with oral and maxillofacial disability, intraoral pathology, developmental anomalies.
2. Children aged 5-7 years with hypoplastic teeth and mobility.
3. Children aged 5-7 years with systemic illness and on regular medication.
4. Teeth with tender on percussion, pulpal exposure, history of pain, and presence of swelling or fistula.
5. Proximal surface caries as evidenced on clinical examination. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
The high-cost GIC material presented a 2-fold more likely survival rate than the low-cost cement with similar cost-effectiveness.   At the end of 3months, 6months and 12monnths 
 
Secondary Outcome  
Outcome  TimePoints 
the survival rates of low cost cement were 87.2%, 81.7%, 67.3% and that of high cost cement were 96.8%, 95.8%, 91.9% at the end of 3months, 6months and 12months respectively. The direct cost of the ART restoration for low-cost cement was Rs. 301.4 per restoration and Rs. 383.7 per restoration for high-cost cement.  3months, 6months, 12months 
 
Target Sample Size   Total Sample Size="94"
Sample Size from India="94" 
Final Enrollment numbers achieved (Total)= "94"
Final Enrollment numbers achieved (India)="94" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   01/07/2016 
Date of Study Completion (India) 01/08/2017 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Dental caries is an infectious disease that has afflicted the human race since ancient times. It is a multifactorial disease that results from interplay of principal factors: the host, the micro flora, and the diet or substrate. Globally, dental caries ranks among the most prevalent diseases of humans. It can start soon after primary teeth erupt in early childhood and continue throughout adulthood. It is a public health problem in most countries. The WHO Global Oral Data Bank indicates improvements in most industrialized nations and deterioration for most developing countries. Despite our ability to prevent this disease, dental caries is still alive and well, affecting large sections of the population. Hence there is a need to adopt various strategies to control dental caries globally.

A shift from the traditional approach of maximal intervention and invasiveness to the approach of minimal intervention and invasion, use of adhesive restorative materials has been a changing trend currently. One of these concepts is the Atraumatic Restorative Treatment (ART) which use glass ionomer cement to restore the cavities.

In countries like India, where the socio-economic status of majority of the population is low, there is less affordability to the dental services. Hence this study aims to check the retention ability of low-cost and high-cost glass ionomer cements as ART restorative material in deciduous molars and also checks for the cost-effectiveness of both the cements.

This was a double blind, randomized clinical trial conducted among 5-7 year old school children in Bangalore city. The informed consent was obtained from the parents of all the participants before the start of the study. Ninety-four school children who satisfied the inclusion and exclusion criteria were selected for the study. Split-mouth technique was used wherein all participants received restorations with two different GIC cements.

The restorations were assessed at the end of 3, 6 and 12 month intervals for the survival rate of both the cements as well as their cost-effectiveness. The results showed that the survival rate of high-cost cement was more than that of the low-cost cement at all the follow-up periods. Direct cost of both the restorations showed that the low cost cement was cost-effective than high cost with a difference of Rs.82.

 
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