Atypical cavities, which involve more than two surfaces, one being buccal or lingual/palatal, are a challenge for restorative dentistry, since the risk of restorative failure is related to the number of surfaces involved. Thus, the purpose of this umbrella project is to conduct a randomized controlled trial (RCT) to evaluate the efficacy and patient-centered outcomes of a chemically activated composite alkasite resin in atypical deciduous molar lesions. Primary molars of children aged 4 to 7 years with at least one atypical cavitary lesion in primary molars will be selected for the RCT. The selected teeth will be randomly divided into: Alkasite chemically activated composite resin and Bulk fill composite resin. Clinical and radiographic follow-up of the lesions will be performed for 6 and 12 months. The effectiveness of the treatments will be evaluated by the longevity of the restorative procedures and paralysis of the lesions. Patient-centered outcomes will also be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
162
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 universal adhesive system and restoration with bulk fill resin composite.
Faculty 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 visual Clinical 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 treatment.
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 treatment.
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 days after treatment.
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 months after treatment.
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