NCT Number: NCT05875064
This study proposes to conduct a randomized clinical trial (RCT), composed of a sample of 194 deciduous central and lateral incisors with active cavitated lesions, simplified ICDAS C+ score, with involvement of more than two surfaces. This sample will be divided into two experimental groups, both with selective removal of carious tissue: a group in which conventional restoration will be performed using opaque resins; and another group with monochromatic resin with chameleon effect and polyvinyl crowns.
Trial opening soon.
Get Notified12 month–60 month
All sexes
Interventional
Phase 3
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Restorative treatment of anterior primary teeth with monochromatic composite resin in single insertion through polyvinyl crowns, after selective removal of carious tissue compared to the effectiveness of conventional restoration.
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue
Time frame: Baseline and after 6, 12, 18 and 24 months.
The integrity of the restoration, its adaptation in all dental faces and identified possible failures related to structural fracture, resin wear, maladaptation or functional maintenance of the restored tooth will be verified.
The clinical evaluation of the retention of the restorations will be performed after 6, 12, 18 and 24 months, using the criteria: total retention; Partial retention 1 - presence of the resin in two thirds of the surface of each dental face; Partial retention 2 - presence of the resin in one third d and each face of the dental surface, total loss of resin on the surface of the dental surface.
It will also be evaluated the degree of tooth mobility and its relationship with the usual exfoliation period in the teeth belonging to both groups. In teeth where the restoration is intact and clinical features of associated lesions are not verified, the lesions will be considered as inactive.
Time frame: Baseline and after 6, 12, 18 and 24 months.
For the evaluation of caries progression, the modified periapical radiographic examination for preschoolers will be used. The images will be compared two by two in order to evaluate whether or not there was progression of caries:
Teeth that present progression of caries lesion to signs of pulp involvement, will receive restorative or endodontic treatment compatible with the observed picture.
Time frame: Baseline and after 6, 12, 18 and 24 months.
To evaluate the perception of parents/guardians in relation to the treatment performed, the questionnaire "Child's and parent's questionnaire about teeth appearance" will be used soon after the first treatment session and 6 months after the treatment. The examiners will guide you to express your real opinion.
Time frame: Baseline and after 6, 12, 18 and 24 months.
The parents/guardians will be asked about their satisfaction with the treatment performed on the child. They will answer 5 "yes" or "no" questions about how much they liked the procedures. The examiners will guide you to issue your real opinion after 6 months of treatment.
Time frame: Baseline and after 6, 12, 18 and 24 months.
A questionnaire will be applied to assess the impact of treatments on children's oral health-related quality of life. The validated Brazilian version of the Early Childhood Oral Health Impact Scale (ECOHIS) should be answered by the parents or guardians of the participants in the initial consultations and at each return. The higher the score, the worse is the children's oral health-related quality of life.
Contact information is provided by the study sponsor or research team.
University of Nove de Julho
Other
Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial
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