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CTRI Number  CTRI/2020/02/023171 [Registered on: 06/02/2020] Trial Registered Prospectively
Last Modified On: 27/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Comparison of two filling materials for treating decay in primary teeth using hand instruments 
Scientific Title of Study   Comparative evaluation of a self curing, fluoride releasing, resin based restorative material with the conventional Glass ionomer cement for Atraumatic Restorative Treatment of deciduous molars in outreach programmes - Split mouth design.  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ranjitha M 
Designation  Post Graduate Student 
Affiliation  Tamil Nadu Government Dental College & Hospital 
Address  Room No- 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College & Hospital, Frazer bridge road Chennai-600003
Room No- 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College & Hospital, Frazer bridge road Chennai-600003
Chennai
TAMIL NADU
600003
India 
Phone  8072901056  
Fax    
Email  ranji15393@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  MB Aswath Narayanan 
Designation  Professor and Head 
Affiliation  Tamil Nadu Government Dental College & Hospital 
Address  Room No- 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College & Hospital, Frazer bridge road Chennai-600003

Chennai
TAMIL NADU
600003
India 
Phone  9840127997  
Fax    
Email  mban1965@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Ranjitha M 
Designation  Post Graduate Student 
Affiliation  Tamil Nadu Government Dental College & Hospital 
Address  No:3/103/64A, Karumapuram P.O, Karipatti Via, Hatsun diary Opp., Vazhapadi (Tk), Salem (DT).
Room No- 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College & Hospital, Frazer bridge road Chennai-600003
Chennai
TAMIL NADU
636106
India 
Phone  8072901056  
Fax    
Email  ranji15393@gmail.com  
 
Source of Monetary or Material Support  
Room No- 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College & Hospital, Frazer bridge road Chennai-600003 
 
Primary Sponsor  
Name  Ranjitha M 
Address  Room no: 310 Tamil Nadu Government Dental College ladies hostel, Muthuswamy road Chennai-600003  
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 
Ranjitha M  Tamil nadu government dental college  Room No- 4, Department of Public Health Dentistry, Tamil Nadu Government Dental College & Hospital, Frazer bridge road Chennai-600003
Chennai
TAMIL NADU 
8072901056

ranji15393@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUITIONAL REVIEW BOARD TAMIL NADU GOVERNMENT DENTAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  DENTAL CARIES 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Glass ionomer cement  GIC was originally invented by Wilson and Kent in the early 1970s and was launched into the market soon after.Glass-ionomer cements (GICs) are the predominant restorative materials used for ART.  
Intervention  Self-curing, fluoride releasing, resin based restorative Material   An innovative tooth-coloured resin based self-curing, fluoride releasing, chemically bonded restorative material using ART approach for deciduous molars. The present study aims to evaluate the survival rate of a self-curing, fluoride releasing, resin based restorative material with conventional glass ionomer restoration for ART in school children in outreach programmes using split mouth design. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  Children with at least two cavitated lesions symmetrically distributed one on the left side and another on the right side of the mandibular arch 
 
ExclusionCriteria 
Details  Cavitated lesions with signs of infection
Physically and mentally challenged subjects
Non-cooperative subjects
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the survival rate of self-curing, fluoride releasing, resin based restorative material with that of glass ionomer cement.
Survival rate includes (Retention, Colour match, Marginal discoloration, Marginal
Integrity, Marginal caries, Anatomical form, Surface texture)
 
6, 12,18 and 24 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Survival rate includes (Retention, Colour match, Marginal discoloration, Marginal
Integrity, Marginal caries, Anatomical form, Surface texture)
 
6, 12,18 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Post Marketing Surveillance 
Date of First Enrollment (India)   10/02/2020 
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="2"
Months="0"
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  

Dental caries is a highly prevalent disease that remains a worldwide public health problem affecting 2.4 billion people with permanent dentition and 621 million children with primary dentition.It affects 60% to 90% of school aged children and up to 100% of adults in most countries. Concurrently, the WHO considers dental caries as the fourth most expensive chronic disease to treat. Dental caries and its consequences are considered as the most important burden of oral health. The resultant pain and discomfort can negatively affect people’s quality of life. Furthermore, the management of this condition imposes huge financial burden on the individuals and ultimately the society. Conventional treatment methods (drill and fill)for Dental caries involves the use of rotary burs alone or in conjunction with hand instruments.Various dental restorative materials are used, ranging from metal based materials such as amalgam to tooth-coloured materials, such as resin composites.

Conventional restorative treatment requires reticulated water and electricity supply which is limited in the outreach programs. Therefore, Atraumatic Restorative Treatment (ART) was developed around 1985, mainly for treating caries in children living in under-served areas of the world where resources and facilities such as electricity and trained manpower are limited. It has been considered an innovative, painless and minimally invasive treatment for the management of caries and restored with an adhesive material (GIC). The advantages of ART include: a biologically friendly approach, low cost, reduced risk for subsequent endodontics and tooth extraction, and lower dental anxiety in children and adults (more patient-friendlier). In addition, people who are elderly, medically-compromised (e.g. HIV infected) or dental phobic can have problems accessing dental care and could benefit from the ART approach. 

 

The performance of ART restorations for longevity has been evaluated through numerous clinical trials with the results of studies showing that ART performs well for occlusal cavities in primary and permanent teeth. Meta-analysis study of two hundred four publications, and 66 reports on ART restorations on survival rate of atraumatic restorative treatment showed high survival rates for single-surface ART restorations using high-viscosity glass ionomers in primary and permanent teeth over 2 and 5 years, respectively. The survival rates of multiple-surface ART restorations using high-viscosity glass ionomers were low for the primary teeth at 2 years and the number of such studies for the permanent teeth was low. The mean annual failure rates of single-surface and multiple surface ART restorations in primary teeth over the first 2 years were 3.5% and 19%, respectively. The mean annual failure rates of single-surface ART restorations using high-viscosity glass ionomers in permanent teeth over the first 3 and 5 years were 5.0% and 4.0%, respectively. The mean annual failure rate of multiple-surface ART restorations using high-viscosity glass ionomers in permanent teeth was 14% over the first year.

Exploration of scientific literature revealed limited studies to date assessing the survival rate of the innovative tooth-coloured resin based self-curing, fluoride releasing, chemically bonded restorative material using ART approach for deciduous molars among underserved paediatric populations with limited water and power supply where conventional restorative treatment (Drill and Fill) is not feasible. Thus, the present study aims to evaluate the survival rate of a self-curing, fluoride releasing, resin based restorative material with conventional glass ionomer restoration for ART in school children in outreach programmes using split mouth design.


 
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