Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT02778503
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.
Study:
NCT02778503
Study Brief:
Protocol Section:
NCT02778503