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

NCT03785769 | Withdrawn

• 1 other identifier: Unib4
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dental Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration

  Immediately after the restoration and 24 months

• Cost-efficacy

  24 months.

• Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale

  Immediately after the treatment

Study Arms (2)

HVGIC restoration with pre-etching

ACTIVE COMPARATOR

Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration.

Procedure: HVGIC restoration with pre-etching

HVGIC restoration with non pre-etching

EXPERIMENTAL

HVGIC restoration without the pre-etching of the surface.

Procedure: HVGIC restoration with non pre-etching

Interventions

HVGIC restoration with pre-etching PROCEDURE

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.

HVGIC restoration with pre-etching

HVGIC restoration with non pre-etching PROCEDURE

Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.

HVGIC restoration with non pre-etching

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Patients with carious lesion of occlusoproximais in primary molars

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Ibirapuera: lead

Study Sites (1)

Tamara Kerber Tedesco

São Paulo, São Paulo, 04545-000, Brazil

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 18, 2018
• First Posted: December 24, 2018
• Study Start: January 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2024
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

BR (1)