Atypical cavities, which involve more than two surfaces being one of them vestibular or lingual/palatine, are a challenge for restorative dentistry, since the risk of failure of the restorations are related to the number of surfaces involved. Thus, the objective of this project is to conduct a randomized clinical trial in order to evaluate the efficacy and patient-centered outcomes of a chemically-activated alkasite composite resin in atypical lesions of deciduous molars. Deciduous molars of children between 4 and 7 years of age with at least one atypical cavity lesion in deciduous molars will be selected for the ECR. The selected teeth will be randomly divided into two groups: Chemically activated composite resin Alkasite and resin-Modified glass ionomer cement. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The efficacy of the treatments will be evaluated by the longevity of the restoring procedures and the arrestment of the caries lesions. Patient-centered outcomes will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
108
Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.
Faculdade Sao Leopoldo Mandic
Campinas, São Paulo, Brazil
RECRUITINGSurvival of restoration
To evaluate the survival of restoration by clinical examination with FDI index.
Time frame: 12 months after treatment.
Caries lesion progression
For the evaluation of caries progression, the interproximal radiographic examination will be used to verify an increase of radiolucent image under restoration.
Time frame: 12 months after treatment.
Secondary caries lesion or on the surface adjacent to the restored tooth
Presence of caries lesion on the surface adjacent to the restored tooth or on the margins of the restoration by means of visualClinical Examination
Time frame: 12 months after treatment.
Perception of children and parents/guardians
To evaluate the satisfaction of the children in relation to the treatment performed. The questionnaire will be used " Child's and parent's questionnaire about teeth appearance".
Time frame: 6 months after treatment.
Operator perception
It will be employed a questionnaire after the completion of the treatment performed. It will also be added a question about the behavior of children during the procedure, which will be categorized as - great behavior, regular or bad.
Time frame: 6 months after the restoration.
Parents/Guardians Satisfaction
The parents/guardians will be questioned about the satisfaction regarding the treatment performed in the child. The answer will be scored by a likert scale.
Time frame: 6 months after restoration.
Child discomfort
The child will also be questioned as to the discomfort in relation to the treatment performed. For this will be used the scale of faces of Wong-Baker.
Time frame: Immediately after the treatment.
Post Operative sensitivity of the child
The child will also be questioned about the sensitivity of the restorative procedure. For this, the Wong-Baker face scale will be used.
Time frame: 7 ° day after the restorative procedure.
Oral health-related quality of life
The validated Brazilian version of Early Childhood Oral Health Impact Scale (ECOHIS) will be applied to children and should be answered by their parents.
Time frame: 6 month of restorative treatment.
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