Comparison of two filling materials for treating decay in primary teeth using hand instruments
- Conditions
- DENTAL CARIES
- Registration Number
- CTRI/2020/02/023171
- Lead Sponsor
- Ranjitha M
- Brief Summary
Dentalcaries is a highly prevalent disease that remains a worldwide public healthproblem affecting 2.4 billion people with permanent dentition and 621 millionchildren with primary dentition.It affects60% 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 expensivechronic disease to treat. Dental caries and itsconsequences are considered as the most important burden of oral health. Theresultant pain and discomfort can negatively affect people’s quality of life.Furthermore, the management of this condition imposes huge financial burden on theindividuals and ultimately the society. Conventional treatment methods (drill and fill)for Dental caries involvesthe use of rotary bursalone or in conjunction with hand instruments.Variousdental restorative materials are used, ranging from metal based materials suchas amalgam to tooth-coloured materials, such as resin composites.
Conventionalrestorative treatment requires reticulated water and electricity supply whichis limited in the outreach programs. Therefore, Atraumatic Restorative Treatment(ART) was developed around 1985, mainly for treating caries in children livingin under-served areas of the world where resources and facilities such aselectricity and trained manpower are limited.It has beenconsidered an innovative, painless and minimally invasive treatment for themanagement of caries and restored with an adhesive material (GIC). The advantages of ART include: a biologically friendlyapproach, low cost, reduced risk for subsequent endodontics and toothextraction, and lower dental anxiety in children and adults (morepatient-friendlier). In addition, people who are elderly, medically-compromised(e.g. HIV infected) or dental phobic can have problems accessing dental care andcould benefit from the ART approach.
The performance ofART restorations for longevity has been evaluated through numerous clinicaltrials with the results of studies showing that ART performs well for occlusalcavities in primary and permanent teeth. Meta-analysisstudy of two hundred four publications, and 66 reports on ART restorations onsurvival rate of atraumatic restorative treatment showed high survival ratesfor single-surface ART restorations using high-viscosity glass ionomers inprimary and permanent teeth over 2 and 5 years, respectively. The survivalrates of multiple-surface ART restorations using high-viscosity glass ionomerswere low for the primary teeth at 2 years and the number of such studies for thepermanent teeth was low. The mean annual failure rates of single-surface andmultiple surface ART restorations in primary teeth over the first 2 years were3.5% and 19%, respectively. The mean annual failure rates of single-surface ARTrestorations using high-viscosity glass ionomers in permanent teeth over thefirst 3 and 5 years were 5.0% and 4.0%, respectively. The mean annual failurerate of multiple-surface ART restorations using high-viscosity glass ionomersin permanent teeth was 14% over the first year.
Exploration ofscientific literature revealed limited studies to date assessing the survivalrate of the innovative tooth-coloured resin based self-curing, fluoridereleasing, chemically bonded restorative material using ART approach for deciduousmolars among underserved paediatric populations with limited water and powersupply where conventional restorative treatment (Drill and Fill) is notfeasible. Thus, the present study aims to evaluate the survival rate of a self-curing,fluoride releasing, resin based restorative material with conventional glassionomer restoration for ART in school children in outreach programmes using splitmouth design.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 30
Children with at least two cavitated lesions symmetrically distributed one on the left side and another on the right side of the mandibular arch.
Cavitated lesions with signs of infection Physically and mentally challenged subjects Non-cooperative subjects.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the survival rate of self-curing, fluoride releasing, resin based restorative material with that of glass ionomer cement. 6, 12,18 and 24 months Survival rate includes (Retention, Colour match, Marginal discoloration, Marginal 6, 12,18 and 24 months Integrity, Marginal caries, Anatomical form, Surface texture) 6, 12,18 and 24 months
- Secondary Outcome Measures
Name Time Method Survival rate includes (Retention, Colour match, Marginal discoloration, Marginal Integrity, Marginal caries, Anatomical form, Surface texture)
Trial Locations
- Locations (1)
Tamil nadu government dental college
🇮🇳Chennai, TAMIL NADU, India
Tamil nadu government dental college🇮🇳Chennai, TAMIL NADU, IndiaRanjitha MPrincipal investigator8072901056ranji15393@gmail.com