Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement (CEPECO4)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03785769|
Recruitment Status : Suspended (The Outbreak of COVID-19.)
First Posted : December 24, 2018
Last Update Posted : June 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dental Caries||Procedure: HVGIC restoration with pre-etching Procedure: HVGIC restoration with non pre-etching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||192 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Masking Description:||Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques|
|Official Title:||Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||March 1, 2021|
|Estimated Study Completion Date :||March 1, 2023|
Active Comparator: HVGIC restoration with pre-etching
Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration.
Procedure: HVGIC restoration with pre-etching
Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
Experimental: HVGIC restoration with non pre-etching
HVGIC restoration without the pre-etching of the surface.
Procedure: HVGIC restoration with non pre-etching
Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
- Survival of restorations [ Time Frame: 24 months ]Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.
- Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration [ Time Frame: Immediately after the restoration and 24 months ]The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.
- Cost-efficacy [ Time Frame: 24 months. ]The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival.
- Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale [ Time Frame: Immediately after the treatment ]Children-reported discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale. The scale present 6 different faces since "very happy" until "very sad" with the treatment.
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): NCT03785769
|Tamara Kerber Tedesco|
|São Paulo, SP, Brazil, 04545-000|