CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 574 enrolled
Drug / intervention
High Cost +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02778503
NCT02778503N/ACompleted

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

Faculty Sao Leopoldo Mandic Campinas·interventional·Posted May 20, 2016·Updated Nov 8, 2017

In Brief

A clinical study evaluating High Cost and Low Cost for Dental Caries. Completed, enrolled 574 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Caries
CountriesBrazil
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 20, 2016
Enrollment StartApr 1, 2016
Primary CompletionNov 1, 2016
Study CompletionNov 1, 2017
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.1 years ago

Interventions

High Costother

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 Costother

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.