Aesthetic Restorations in Deciduous Anterior Teeth

Dental Caries in Children Clinical Trial

Official title:

Aesthetic Restorations in Deciduous Anterior Teeth - Study Protocol for a Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05875064
• Other study ID #: RehabAnteriorUnimes
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: August 1, 2023
• Est. completion date: July 30, 2025

Study information

• Verified date: May 2023
• Source: University of Nove de Julho
• Contact: Thais Gimenez
• Phone: +5511989456585
• Email: thais.gimenez[@]alumni.usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 194
• Est. completion date: July 30, 2025
• Est. primary completion date: July 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 60 Months

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Combination Product:
• Restoration 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.

Procedure:
• Restoration with conventional resin composite
Restorative treatment of anterior primary teeth with conventional composite resin, after selective removal of carious tissue

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in progression of caries lesion through clinical criteria and longevity of restorations	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.	Baseline and after 6, 12, 18 and 24 months.
Secondary	Change in the progression of caries lesion by radiographic criteria	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: Absent progression: when there is no increase in the radiolucent area of the lesion.; 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.	Baseline and after 6, 12, 18 and 24 months.
Secondary	Change in the perception of parents/guardians	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.	Baseline and after 6, 12, 18 and 24 months.
Secondary	Change in the satisfaction of parents/guardians	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.	Baseline and after 6, 12, 18 and 24 months.
Secondary	Change in the impact of treatments on children's oral health-related quality of life	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.	Baseline and after 6, 12, 18 and 24 months.