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NCT Number: NCT02778503

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

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

4 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

High Cost

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

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.

Primary outcomes

  1. 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

  1. Cost-effectiveness

    Time frame: Through study completion (12 months)

    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/).

  2. Impact on children's quality of life

    Time frame: Baseline and 12 months

    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.

  3. Children self-reported discomfort

    Time frame: Baseline

    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.

  4. Caries lesions progression

    Time frame: Every 6 months up to 12 months

    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.

Sponsors and collaborators

Lead sponsor

Faculty Sao Leopoldo Mandic Campinas

Other

Registry information

Official study title

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

Acronym: SLM1797

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 20, 2016
Registry last updated
Nov 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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