Dental caries
Conditions
Interventions
Control group 1: 75 children were treated with atraumatic restorative treatment (ART), with KetacMolarEasymix®, 3M/ESPE, Seefeld, GE. Experimental group 2: 75 children were treated with ART, using Max
Procedure/surgery
Sponsors
Universidade Cruzeiro do Sul
Universidade Camilo Castelo Branco
Eligibility
Age
4 Years to 5 Years
Inclusion criteria
Inclusion criteria: "healthy volunteers; both genders; between 4 and 5 years of age; clinically presenting proximal caries lesion in primary teeth; lesion accessible to manual instruments used in atraumatic restorative treatment".
Exclusion criteria
Exclusion criteria: "non-cooperative children; presence of fistula or abscess near the tooth selected to the research; presence of pulp exposure or mobility in the selected tooth".
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected primary outcomes: clinical evaluation of restorations: the group in which teeth was restored with Ketac Molar Easymix should present superior clinical performance when compared to the group in which teeth was restored with Maxxion R, since it is believed that the Ketac Molar Easymix is considered the gold standard in trials due to a high viscosity. We have no information regarding the viscosity of Maxxion R Method used to verify the expected outcome: the outcome will be evaluated at 6 months, 12 months and 24 months after the treatment performed, according to the criteria of Roeleveld, van Amerongen e Mandari (2006) Parameters used to verify that the outcome really happened: will be held the association of possible failures of the restorations and the associated factors, such as: type of material, upper or lower arch, the side of the mouth (right or left), the surface (medial or distal) and the tooth (first or second molar). For this, there will be performed the Cox regression test. Odds ratio 95% CI (confidence Interval) | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected secondary outcome: clinical evaluation of restorations at 6, 12, and 24 months after the treatment performed: caries activity in the adjacent restoration tooth should be lower in teeth restored with Ketac Molar Easymix due to the material fluoride release, and the best clinical performance of the material Method used to verify the expected outcome: will be held the association between failure of restorations according to the scores of Roeleveld et al. (2006) and associated factors tested by univariate and multiple Cox regression test Presentation of the parameters used to verify that the outcome really happened: association between failure of restorations and parameters such as gender; biofilm in the initial assessment, 14 and 24 months; type of tooth (first or second molar); side of the mouth (right or left); arch (upper or lower); the treated surface (medial or distal); the presence of antagonist tooth; the presence of adjacent tooth, ICDAS for the restored tooth; caries activity in the restored tooth; and the adjacent tooth restoration (positive or negative caries activity) | — |
Countries
Brazil
Contacts
Public ContactCintia;José Carlos Gargioni;Imparato
Universidade Cruzeiro do Sul;Universidade Camilo Castelo Branco
Outcome results
None listed