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Clinical Trials/NCT02778503
NCT02778503
Completed
Not Applicable

Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs: a Randomized Controlled Trial

Faculty Sao Leopoldo Mandic Campinas1 site in 1 country574 target enrollmentApril 2016
ConditionsDental Caries

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Dental Caries
Sponsor
Faculty Sao Leopoldo Mandic Campinas
Enrollment
574
Locations
1
Primary Endpoint
Restoration survival
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
November 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Faculty Sao Leopoldo Mandic Campinas
Responsible Party
Principal Investigator
Principal Investigator

Jose Carlos P Imparato

PhD, Senior Lecturer

Faculty Sao Leopoldo Mandic Campinas

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Restoration survival

Time Frame: 12 months

The restoration will be classified according to the scores described by Frencken et al. (1994) and Roeleveld et al. (2006).

Secondary Outcomes

  • Impact on children's quality of life(Baseline and 12 months)
  • Cost-effectiveness(Through study completion (12 months))
  • Children self-reported discomfort(Baseline)
  • Caries lesions progression(Every 6 months up to 12 months)

Study Sites (1)

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