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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

Tracking Information
First Submitted Date  ICMJE December 18, 2018
First Posted Date  ICMJE December 24, 2018
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE April 1, 2020
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration [ Time Frame: 24 months ]
    The caries lesion progression will be evaluated by comaparison of radiograph immediately after the restoration and after 24 months.
  • 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.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pre-etching of Dentin Before Restorations With High Viscosity Glass Ionomer Cement
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: HVGIC restoration with pre-etching
    Pre-etching of the surface with polyacrylic acid for 10 s, followed by HVGIC restoration.
    Intervention: Procedure: HVGIC restoration with pre-etching
  • Experimental: HVGIC restoration with non pre-etching
    HVGIC restoration without the pre-etching of the surface.
    Intervention: Procedure: HVGIC restoration with non pre-etching
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 1, 2023
Estimated Primary Completion Date March 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 8 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03785769
Other Study ID Numbers  ICMJE Unib4
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Individual participant data will be available on Mendeley database.
Responsible Party Tamara Kerber Tedesco, Universidade Ibirapuera
Study Sponsor  ICMJE Universidade Ibirapuera
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Universidade Ibirapuera
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP