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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03785769
Recruitment Status : Suspended (The Outbreak of COVID-19.)
First Posted : December 24, 2018
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Tamara Kerber Tedesco, Universidade Ibirapuera

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 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
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Survival of restorations [ Time Frame: 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 :
  1. Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration [ Time Frame: 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.

  2. Cost-efficacy [ Time Frame: 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.

  3. Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale [ Time Frame: 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.



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Ages Eligible for Study:   4 Years to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785769


Locations
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Brazil
Tamara Kerber Tedesco
São Paulo, SP, Brazil, 04545-000
Sponsors and Collaborators
Universidade Ibirapuera
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Responsible Party: Tamara Kerber Tedesco, Principal investigator, Universidade Ibirapuera
ClinicalTrials.gov Identifier: NCT03785769    
Other Study ID Numbers: Unib4
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: June 12, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available on Mendeley database.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases