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
|
|
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
|
|
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.
|