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

NCT02778503 | Completed

• 1 other identifier: SLM2
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Cost-effectiveness

  Through study completion (12 months)

• Impact on children's quality of life

  Baseline and 12 months

• Children self-reported discomfort

  Baseline

• Caries lesions progression

  Every 6 months up to 12 months

Study Arms (2)

High Cost

ACTIVE COMPARATOR

Restoration using a high-cost glass ionomer cement.

Other: High Cost

Low Cost

EXPERIMENTAL

Restoration using a low-cost glass ionomer cement.

Other: Low Cost

Interventions

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.

High Cost

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.

Low Cost

Eligibility Criteria

• Age: 4 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Faculty Sao Leopoldo Mandic Campinas: lead

Study Sites (1)

Faculty Sao Leopoldo Mandic

Campinas, São Paulo, 13045755, Brazil

Location

Related Publications (6)

• 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.

  PMID: 9165195 BACKGROUND

• 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.

  PMID: 8915958 BACKGROUND

• 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.

  PMID: 19761288 BACKGROUND

• 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.

  PMID: 17140533 BACKGROUND

• 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.

  PMID: 18709230 BACKGROUND

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

  PMID: 3344163 BACKGROUND

MeSH Terms

Conditions

Dental Caries

Interventions

Technology, High-Cost

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Technology Assessment, Biomedical; Health Care Economics and Organizations

Study Officials

• Jose Carlos P Imparato, PhD

  Faculty Sao Leopoldo Mandic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Senior Lecturer

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: May 20, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: November 8, 2017

Record last verified: 2017-11

Locations

BR (1)