Use of colored material in primary tooth restorations: a study to evaluate clinical results

Colored compomer in the restorative treatment of deciduous teeth: a randomized controlled clinical trial -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REBEC

Registry ID

RBR-105hz5mr

Enrollment

100

Registered

2026-05-18

Start date

2026-08-03

Completion date

Unknown

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries Dental Materials

Interventions

This is a two-arm, randomized, blinded clinical trial. The sample will consist of 100 participants aged 6 to 8 years who present with cavitated caries lesions on the occlusal surface (Class I), occlus

and G2 (N=50) - control group that will receive restoration with Glass Ionomer Cement (Riva Light Cure, SDI, Bayswater, Australia). The parents/guardians of the children will answer a pre-structured q

s sex, age, medical history, educational level of the guardians, monthly family income, number of people living on the income, number of children, diet, and oral hygiene. A single, previously trained

Eligibility

Age

6 Years to 8 Years

Inclusion criteria

Inclusion criteria: Children aged 6 to 8 years; male or female; with deciduous or mixed dentition; who have at least one first or second lower deciduous molar with a Black class I (occlusal caries) or class II (mesial or distal occlusal caries) caries lesion

Exclusion criteria

Exclusion criteria: Children with systemic disorders (syndromes and neurological disorders); who are using orthodontic appliances; teeth with enamel development defects; teeth with mobility; teeth with pulp involvement

Design outcomes

Primary

Measure	Time frame
Children with primary teeth restored with colored compomers are expected to have a higher level of satisfaction than children with teeth restored with resin-reinforced glass ionomer cement. Satisfaction with the restored tooth will be greater at T1 (7 days after the procedure) and T2 (1 month after the procedure) than at baseline (before the restorative procedure);It is expected that the visible plaque index and the gingival bleeding index will be lower in group G1 (colored compomer) than in group G2 (glass ionomer) at time T1 (7 days after the procedure) and T2 (1 month after the procedure)	—

Measure

Time frame

Children with primary teeth restored with colored compomers are expected to have a higher level of satisfaction than children with teeth restored with resin-reinforced glass ionomer cement. Satisfaction with the restored tooth will be greater at T1 (7 days after the procedure) and T2 (1 month after the procedure) than at baseline (before the restorative procedure);It is expected that the visible plaque index and the gingival bleeding index will be lower in group G1 (colored compomer) than in group G2 (glass ionomer) at time T1 (7 days after the procedure) and T2 (1 month after the procedure)

—

Secondary

Measure	Time frame
Parent/caregiver satisfaction levels are expected to be higher in group G1 (colored compomer) than in group G2 (glass ionomer) at time points T1 (7 days after the procedure) and T2 (1 month after the procedure);Sociodemographic factors are expected to influence the level of satisfaction and biofilm control	—

Countries

Contacts

Public ContactRaquel Gonçalves de Andrade

Universidade Federal de Minas Gerais

posgrad@odonto.ufmg.br+55 (31) 3409-2470

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Jun 11, 2026