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

Sponsor

Universidade Ibirapuera (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03785769

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Procedure: HVGIC restoration with pre-etching Procedure: HVGIC restoration with non pre-etching	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double-blind (Patient and Examiner) will not be able to blinding the operator due to the obvious difference between the techniques

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Survival of restorations [24 months]
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.

Secondary Outcome Measures

Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration [Immediately after the restoration and 24 months]
The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.
Cost-efficacy [24 months.]
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.
Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale [Immediately after the treatment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Years to 8 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tamara Kerber Tedesco	São Paulo	SP	Brazil	04545-000

Sponsors and Collaborators

Universidade Ibirapuera

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tamara Kerber Tedesco, Principal investigator, Universidade Ibirapuera

ClinicalTrials.gov Identifier:

NCT03785769

Other Study ID Numbers:

Unib4

First Posted:

Dec 24, 2018

Last Update Posted:

Jun 1, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Jun 1, 2022