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

Dental Caries Clinical Trial

— CEPECO4  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03785769
• Other study ID #: Unib4
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2022
• Source: Universidade Ibirapuera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Tamara Kerber Tedesco	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Ibirapuera

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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.
Secondary	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