Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement (CEPECO4)

Effect of Pre-etching of Dentin on Survival of Restorations With High Viscosity Glass Ionomer Cement in the Atraumatic Restorative Treatment - Randomized Clinical Trial Restorations With High Viscosity Glass Ionomer Cement

The objective of this randomized clinical trial is to evaluate the survival of restoration with high viscosity glass ionomer cement (HVGIC) with pre-etching with polyacrilic acid compared with no pre-etching in order to treat occlusoproximais caries lesion in primary molars, as well as the impact of those treatments in the caries lesion progression, the cost-efficacy of the procedures and the discomfort reported by the patient. Children of 4 to 8 years will be selected in the Pediatric Dentistry Clinic of Universidade Ibirapuera. 192 teeth will be randomized in 2 experimental groups: (1) HVGIC restoration with pre-etching and (2) HVGIC restoration with no pre-etching. Will be considered as primary outcome the survival of the restoration evaluated after 6, 12, and 24 months by two trained examiners. The carious lesions progression will be evaluated after 24 months of follow-up. The time of the treatments and the cost of the materials will be considered to estimate the cost-efficacy of each treatment. The discomfort reported by the participant will be measured after each procedure following the Wong-Baker scale. For the primary outcome, Kaplan-Meier survival and the Long-Rank test will be used in order to compare the two groups. Cox regression will be performed in order to evaluate thee influence of explanatory variables on the outcome.

Study Overview

• Status: Withdrawn
• Conditions: Dental Caries
• Intervention / Treatment: Procedure: HVGIC restoration with pre-etching; Procedure: HVGIC restoration with non pre-etching

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04545-000
      • Tamara Kerber Tedesco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients with carious lesion of occlusoproximais in primary molars

Exclusion Criteria:

• Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
• Also, teeth with pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, sealants or enamel formation defects will also be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: HVGIC restoration with pre-etching; Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration.	Procedure: HVGIC restoration with pre-etching; Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
EXPERIMENTAL: HVGIC restoration with non pre-etching; HVGIC restoration without the pre-etching of the surface.	Procedure: HVGIC restoration with non pre-etching; Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival of restorations	Comparing the survival of HVGIC restorations without pre-etching with HVGIC restorations with pre-etching by clinical assessment using a criteria proposed by Roleveld et al., 2006.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration	The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.	Immediately after the restoration and 24 months
Cost-efficacy	The duration of the treatments (time of treatment) and the cost of the materials used will be considered for the estimation of the cost-efficacy of the treatments by a ratio - cost/efficacy, being efficacy considered the tooth survival.	24 months.
Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale	Children-reported discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale. The scale present 6 different faces since "very happy" until "very sad" with the treatment.	Immediately after the treatment

Collaborators and Investigators

• Sponsor: Universidade Ibirapuera

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: December 18, 2018
• First Submitted That Met QC Criteria: December 21, 2018
• First Posted (ACTUAL): December 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: Unib4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data will be available on Mendeley database.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No