Clinical trial NCT02778503: Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs
Official title: Effectiveness of Atraumatic Restorative Treatment Using Glass Ionomer Cement of Different Costs: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Tooth, Deciduous
Dentition, Permanent
Dental Atraumatic Restorative Treatment
Glass Ionomer Cements
Dental Caries
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2016-05-20
Enrollment: 574
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Restoration survival
timeFrame: 12 months
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: Through study completion (12 months)
measure: Impact on children's quality of life
timeFrame: Baseline and 12 months
measure: Children self-reported discomfort
timeFrame: Baseline
measure: Caries lesions progression
timeFrame: Every 6 months up to 12 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculty Sao Leopoldo Mandic
state: Sao Paulo
Study officials:
affiliation: Faculty Sao Leopoldo Mandic
name: Jose Carlos P Imparato, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.