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Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial

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ClinicalTrials.gov Identifier: NCT02962713
Recruitment Status : Active, not recruiting
First Posted : November 11, 2016
Last Update Posted : March 29, 2018
Sponsor:
Information provided by (Responsible Party):
Daniela Prócida Raggio, University of Sao Paulo

Brief Summary:
Although the Atraumatic Restorative Treatment (ART) is well settled in the literature regarding occlusal-proximal cavities, the longevity of these restorations is still lower when compared to occlusal ones. This factor is often associated with low mechanical properties of glass ionomer cements (GIC). The objective of this randomized clinical trial is to evaluate the long-term cost-effectiveness of two different materials: an encapsulated GIC - Equia (GC Corp), compared with Giomer (Beautifill Bulk Restorative - Shofu) used as restoratives materials in occlusal-proximal ART restorations of primary molars. Children aged between 4 and 6 years, will be selected in schools in the city of Barueri, São Paulo. All restorations will be held following the precepts of the ART and the manufacturer's instructions. The restorations will be evaluated after 6, 12 and 24 months according to Roeleveld et al. (2006) criteria. To verify the survival of the restorations will be used Kaplan-Meier survival analysis and log rank test. To evaluate the association between the clinical variables, Cox regression test will be applied. For the cost analysis will be used analysis of variance. The level of significance for all tests will be considered to 5%.

Condition or disease Intervention/treatment Phase
Dental Caries Procedure: ART with Equia Procedure: ART with Giomer Beautifil-Bulk Restorative Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Giomer vs Glass Ionomer Cement for ART Occlusoproximal Restorations: a Randomized Clinical Trial
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ART with Equia
Occlusal-proximal restoration in primary molars using Equia (Easy/Quick/Unique/Intelligent/Aesthetic) from GC Corp, encapsulated, pre-dosed and mechanized handling.
Procedure: ART with Equia
Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.

Experimental: ART with Giomer Beautifil-Bulk Restorative
Occlusal-proximal restoration in primary molars using Giomer Beautifil-Bulk Restorative (SHOFU Inc)
Procedure: ART with Giomer Beautifil-Bulk Restorative
Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.




Primary Outcome Measures :
  1. Longevity of atraumatic restoration using Roeleveld et al. (2006) criteria [ Time Frame: up to 24 months ]
    The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failure" will be analyzed. "Minor failures" are those in which there is a defect in the restoration, but it does not interfere in the tooth health.


Secondary Outcome Measures :
  1. Cost-efficacy assessment based on Takanashi et al., 2004; Oscarson et al., 2003;Floriano et al., 2013 [ Time Frame: an average of 24 months ]
    The direct cost analysis of the ART performed with the encapsulated GICs will be based on previous publications (Takanashi et al., 2004; Oscarson et al., 2003) adjusted to the Brazilian reality (Floriano et al., 2013). For this, we will consider professional cost and cost of the procedure itself.



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Ages Eligible for Study:   4 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children aging between 4 and 9 years
  • Children presenting good health conditions
  • Children whose parents or legal guardians accept and sign the consent form
  • Children with at least one occlusal proximal caries lesion in primary molars
  • only occlusal-proximal surfaces with caries lesions with dentin involvement

Exclusion Criteria:

  • severe behavioral issues
  • presence of fistula or abscess near the selected tooth
  • presence of pulp exposure in the selected tooth
  • presence of mobility in the selected tooth

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02962713


Locations
Brazil
University of Sao Paulo
Sao Paulo, Brazil, 05508-000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Daniela P Raggio, Professor University of Sao Paulo

Publications of Results:

Other Publications:
Responsible Party: Daniela Prócida Raggio, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02962713     History of Changes
Other Study ID Numbers: GIOMERART
First Posted: November 11, 2016    Key Record Dates
Last Update Posted: March 29, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Daniela Prócida Raggio, University of Sao Paulo:
Atraumatic Restorative Treatment
glass ionomer cement
primary teeth
dental caries.

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents