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

Study Overview
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: High Cost
* Other: Low Cost


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Cost<br>Restoration using a high-cost glass ionomer cement. | Other: High Cost<br>* 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.<br>|
| Experimental: Low Cost<br>Restoration using a low-cost glass ionomer cement. | Other: Low Cost<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration survival | The restoration will be classified according to the scores described by Frencken et al. (1994) and Roeleveld et al. (2006). | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness | The costs of each treatment procedure will be calculated and compared with thresholds values for intervention cost-effectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/). | Through study completion (12 months) | 
| Impact on children's quality of life | The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The Early Childhood Oral Health Impact Scale (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The Child Perceptions Questionnaire (CPQ) will be used for 6-9 years old children (Martins et al., 2009). They will be applied immediately before the procedure and on 12 months follow-up. | Baseline and 12 months | 
| Children self-reported discomfort | The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences. | Baseline | 
| Caries lesions progression | The treatments will be evaluated radiographically. This evaluation will be performed by two blinded examiners, which will evaluate the four patients' radiographies (baseline, after treatment, 6 months, 12 months) independently, two by two, without knowing the chronological order of them. The efficacy of the treatment will be related to the presence or absence of increasing radiolucent area. They will also classify each radiography using Ekstrand criteria (Ekstrand et al., 1997) and analyze them in a software (ImageJ 1.49, National Institute of Health, USA) in order to make the radiographic subtraction. | Every 6 months up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth, Deciduous, Dentition, Permanent, Dental Atraumatic Restorative Treatment, Glass Ionomer Cements, Dental Caries