Dental Caries in Children
Conditions
Brief summary
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.
Interventions
COMBINATION_PRODUCTRestoration with resin composite and polyvinyl crown
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.
PROCEDURERestoration with conventional resin composite
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This is a non-inferiority randomized clinical trial with parallel arms, with an allocation ratio of 1:1
Eligibility
Sex/Gender
ALL
Age
12 Months to 60 Months
Healthy volunteers
No
Inclusion criteria
* Children ranging in age from 12 to 60 months with at least one active cavitated caries lesion involving more than 2 surfaces (C+ score) in deciduous upper incisors will be included.
Exclusion criteria
* Patients with special needs, with general health conditions that may affect the oral cavity, whose guardians do not sign the Inform Consent Form will be excluded. In addition, teeth with pulp exposure, spontaneous pain, mobility, presence of swelling or fistula near the tooth and teeth with previous restorations; less than 2/3 of root (radiographically assessed), teeth without an antagonist, teeth with previous restorations and children with bruxism and/or deep bite.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in progression of caries lesion through clinical criteria and longevity of restorations | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the progression of caries lesion by radiographic criteria | 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: 1. Absent progression: when there is no increase in the radiolucent area of the lesion. 2. Progression present: when there is an increase in the radiolucent area of the lesion. Teeth that present progression of caries lesion to signs of pulp involvement, will receive restorative or endodontic treatment compatible with the observed picture. |
| Change in the perception of parents/guardians | 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. |
| Change in the satisfaction of parents/guardians | 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. |
| Change in the impact of treatments on children's oral health-related quality of life | 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. |
Contacts
Primary ContactThais Gimenez
Outcome results
None listed