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Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs

NCT ID: NCT02778503

Last Updated: 2017-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

574 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-11-30

Brief Summary

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Atraumatic Restorative Treatment (ART) is an alternative restorative technique for dental caries, applying the partial caries tissue removal philosophy using hand instruments, relative cotton rolls isolation, immediate restoration with Glass Ionomer Cements (GIC) and avoiding local anesthesia. The chosen material for this study will be the High Viscosity Glass Ionomer Cement (HVGIC) due to its unique physical-chemical properties as well as its applicability in challenging clinical situations where other materials would not be adequate. Although there are substantial evidences regarding GIC properties, information about GIC (with different costs) longevity is still weak. Therefore, the objective of this study is to assess the effectiveness of ART restorations performed with low-cost HVGIC in cavitated dentine carious lesions in primary and permanent molars. This will be a multicenter randomized controlled double-blind (patient and operator) clinical trial performed with 680 primary and/or permanent molars in children between 4 and 9 years old presenting cavitated dentine carious lesions in occlusal and occlusal-proximal surfaces. The tooth will be considered as the unit sample, which will be randomly allocated to the groups through a generated random list numbers and distributed in dark sealed envelopes opened only by dental assistants. Teeth in the test group will be submitted to restorative treatment with HVGIC Vitro Molar and those in the control group with HVGIC Fuji IX. The restoration effectiveness will be assessed by means of both clinical and bitewing x-rays control after 6 and 12 months.

Detailed Description

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Conditions

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Dental Caries

Keywords

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Tooth, Deciduous Dentition, Permanent Dental Atraumatic Restorative Treatment Glass Ionomer Cements Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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High Cost

Restoration using a high-cost glass ionomer cement.

Group Type ACTIVE_COMPARATOR

High Cost

Intervention Type OTHER

Surfaces allocated to this group will be treated with a high-cost glass ionomer cement restoration (Fuji IX, GC America, USA), according to the manufacturer's instructions.

Low Cost

Restoration using a low-cost glass ionomer cement.

Group Type EXPERIMENTAL

Low Cost

Intervention Type OTHER

Surfaces allocated to this group will be treated with a low-cost glass ionomer cement restoration (Maxxion R, FGM, BRA), according to the manufacturer's instructions.

Interventions

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High Cost

Surfaces allocated to this group will be treated with a high-cost glass ionomer cement restoration (Fuji IX, GC America, USA), according to the manufacturer's instructions.

Intervention Type OTHER

Low Cost

Surfaces allocated to this group will be treated with a low-cost glass ionomer cement restoration (Maxxion R, FGM, BRA), according to the manufacturer's instructions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children with at least one primary and/or permanent molar with dentine carious lesion in the occlusal and/or occlusal-proximal surface.

Exclusion Criteria

* Special need patients, subjects under orthodontic treatment and/or systemically compromised.
* Teeth with restorations, sealants, developmental defects, deep carious lesions with pulpal exposure risk, fistula and/or abscess, and those with history of spontaneous pain.
Minimum Eligible Age

4 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Faculty Sao Leopoldo Mandic Campinas

OTHER

Sponsor Role lead

Responsible Party

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Jose Carlos P Imparato

PhD, Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose Carlos P Imparato, PhD

Role: PRINCIPAL_INVESTIGATOR

Faculty Sao Leopoldo Mandic

Locations

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Faculty Sao Leopoldo Mandic

Campinas, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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Ekstrand KR, Ricketts DN, Kidd EA. Reproducibility and accuracy of three methods for assessment of demineralization depth of the occlusal surface: an in vitro examination. Caries Res. 1997;31(3):224-31. doi: 10.1159/000262404.

Reference Type BACKGROUND
PMID: 9165195 (View on PubMed)

Frencken JE, Pilot T, Songpaisan Y, Phantumvanit P. Atraumatic restorative treatment (ART): rationale, technique, and development. J Public Health Dent. 1996;56(3 Spec No):135-40; discussion 161-3. doi: 10.1111/j.1752-7325.1996.tb02423.x.

Reference Type BACKGROUND
PMID: 8915958 (View on PubMed)

Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.

Reference Type BACKGROUND
PMID: 19761288 (View on PubMed)

Roeleveld AC, van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006 Jun;7(2):85-91. doi: 10.1007/BF03320820.

Reference Type BACKGROUND
PMID: 17140533 (View on PubMed)

Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.

Reference Type BACKGROUND
PMID: 18709230 (View on PubMed)

Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.

Reference Type BACKGROUND
PMID: 3344163 (View on PubMed)

Other Identifiers

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SLM2

Identifier Type: -

Identifier Source: org_study_id