Aesthetic Restorations in Deciduous Anterior Teeth

NCT05875064 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: RehabAnteriorUnimes
• Study Type: interventional
• Target: 194
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in the progression of caries lesion by radiographic criteria

  Baseline and after 6, 12, 18 and 24 months.

• Change in the perception of parents/guardians

  Baseline and after 6, 12, 18 and 24 months.

• Change in the satisfaction of parents/guardians

  Baseline and after 6, 12, 18 and 24 months.

• Change in the impact of treatments on children's oral health-related quality of life

  Baseline and after 6, 12, 18 and 24 months.

Study Arms (2)

conventional restoration group (control)

ACTIVE COMPARATOR

The teeth allocated in the conventional restoration group (control) will receive restorations in resin composed by incremental technique, using opaque resin. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire dental surface, photoactivation of the adhesive and restoration by incremental technique and photoactivation of each layer of resin for 20 seconds. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).

Procedure: Restoration with conventional resin composite

polyvinyl crown - experimental group

EXPERIMENTAL

The teeth allocated in the experimental group will have the restorations carried out through monochromatic composite resin with chameleon effect in single insertion through polyvinyl crown. For this, 37% phosphoric acid (Condac37, FGM) will be applied for 15 seconds, and then, after washing and relative drying of the surface, application of universal adhesive (Universal Beautibond Adhesive, Shofu) with the aid of microbrush on the entire tooth surface, photoactivation of the adhesive and adaptation of the crown matrix in acetate filled with resin in the tooth. Photoactivation will be done for 20 seconds per dental face, and the acetate matrix is then removed. The tooth will receive finishing and polishing through rotating instruments and abrasive discs (Supersnap, Shofu).

Combination Product: Restoration with resin composite and polyvinyl crown

Interventions

Restoration with resin composite and polyvinyl crown COMBINATION_PRODUCT

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.

polyvinyl crown - experimental group

Restoration with conventional resin composite PROCEDURE

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

conventional restoration group (control)

Eligibility Criteria

• Age: 12 Months - 60 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

Related Publications (1)

• Gimenez T, Sobral APT, Santos EM, Goncalves MLL, Ferri EP, Gallo JMAS, Horliana ACRT, Motta LJ, Imparato JCP, Bussadori SK. An investigator-blinded, 24-month, parallel-group, non-inferiority study to compare aesthetic restorations in primary anterior teeth in a paediatric dental clinic: study protocol for a randomised controlled trial. BMJ Open. 2025 Feb 6;15(2):e086200. doi: 10.1136/bmjopen-2024-086200.

  PMID: 39915031 DERIVED

MeSH Terms

Interventions

Composite Resins

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Thais Gimenez

CONTACT

+5511989456585; thais.gimenez@alumni.usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a non-inferiority randomized clinical trial with parallel arms, with an allocation ratio of 1:1

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 25, 2023
• Study Start: January 26, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL