Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Ultraconservative Caries Treatment in Anterior Cavitated Caries Lesion of Primary Teeth (CEPECO2)

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: NCT03785730
Recruitment Status : Suspended (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 30, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
Tooth survival by clinical assessment [ Time Frame: 24 months ]
Comparing the survival of teeth treated with restoration of composite resin and with UTC for lesions cavitated in anterior primary teeth by clinical assessment, considering the presence of tooth in the cavity without the need for a new treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2019)
  • Discomfort regarding the treatment options by a Face image scale (FIS) [ Time Frame: Immediately after treatment ]
    Children-reported discomfort regarding the treatment options by a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Higher scores mean a worse discomfort.
  • Cost-efficacy analysis [ 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.
  • Perception of parents / guardians evaluated through questionnaire [ Time Frame: Prior to treatment, immediately after and 6 months later. ]
    Parents perception of the treatments will be evaluated through a questionnaire - "Child's and parent's questionnaire about teeth appearance" - with possible answers varying from very satisfied until insatisfied. After the questionnaire is applied for the parents/guardians, the anwsers will bem transformed in scores 1 to 5, in according the original paper that validated the questionnaire. Higher scores mean a worse perception.
  • Satisfaction of children: questionnaire [ Time Frame: After 6 months ]
    Children-reported satisfaction regarding the treatment by a questionnaire with five question which for answers will be used a Face image scale (FIS). The scale present 5 different faces since "very happy" (scored as 1) until "very sad" (scored as 5) with the treatment. Lower scores mean a better satisfaction.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2018)
  • Discomfort regarding the treatment options by a Wong-Baker FACES pain rating scale [ Time Frame: Immediately after 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.
  • Cost-efficacy analysis [ 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.
  • Perception of parents / guardians evaluated through questionnaire [ Time Frame: Prior to treatment, immediately after and 6 months later. ]
    Parents perception of the treatments will be evaluated through questionnaires.
  • Parent / Guardian Satisfaction evaluated through questionnaires [ Time Frame: Prior to treatment, immediately after and 6 months later. ]
    Parents satisfaction of the treatments will be evaluated through questionnaires.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ultraconservative Caries Treatment in Anterior Cavitated Caries Lesion of Primary Teeth
Official Title  ICMJE Impact of Ultraconservative Caries Treatment in Anterior Cavitated Caries Lesion of Primary Teeth on Survival of Teeth and Patient-reported Outcomes - Randomized Clinical Trial
Brief Summary The objective of this randomized clinical trial is to evaluate the efficacy of composite resin (CR) restorations compared to ultraconservative (UTC) treatment for proximal anterior teeth cavitated caries lesions, as well as the impact of these treatments on the cost-effectiveness of procedures, the discomfort of the patient in relation to the different techniques and in the perception of parents / guardians regarding the treatments received. Children aged 3 to 6 years will be randomly selected from the Clinical Center for Pediatric Dentistry at UNIB, at the Clinic of Infants and Pediatric Dentistry at Santa Cecília University and at Pediatric Dentistry Clinic at UNINOVAFAPI University Center. 196 teeth will be randomized into two experimental groups: (1) Selective removal of carious tissue and restoration with composite resin (RC) and (2) Ultraconservative treatment by means of cavity enlargement using metal sandpaper (UTC). The primary outcome will be the survival of the tooth that will be evaluated after 6, 12, 18 and 24 months by two trained and blinded examiners for the treatments performed. The duration of the treatments and the cost of the materials used will be considered for the estimation of the cost-effectiveness of each treatment. The discomfort reported by the participant will be measured after each procedure using the FIS scale. Parents perception will be evaluated through questionnaire. For the primary outcome, Kaplan-Meier survival and Cox regression with shared frailty will be used for comparison between groups. For all analyzes, the significance value will be adjusted to 5%.
Detailed Description

This is a randomized controlled, two-arms parallel-group (1:1) trial. Initially, it will be submitted to the Research Ethics Committee of the Ibirapuera University - UNIB. The other centers involved will be considered as co-participants (Santa Cecilia University - UNISANTA and Uninovafapi University Center - UNINOVAFAPI). Only those patients who meet the eligibility criteria will be included in the study after signing the Informed Consent Form by the parents and the child's assent to study participation.

In order to carry out the sample calculation, the expected survival for the primary teeth with cavitated lesions on the proximal surface submitted to ultraconservative treatments is 89.7% after a period of 24 months (Mijan et al., 2014). Thus, a clinically significant difference is expected to be 20% in the success rate between the groups. With this, adopting a level of significance of 0.05 and a power of 0.80, we reached the number of 136 patients. Since each child can contribute more than one tooth, 20% was added to that value (cluster per child), and 20% due to a possible sample loss. Thus, the final rounded number of 98 teeth per group resulted in 196 teeth in total (MedCalc version 15.8, Ostend, BE).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dental Caries
Intervention  ICMJE
  • Procedure: UCT
    In the experimental group, the treatment will be performed after prophylaxis and relative isolation. The cavitated caries lesion will be widened with the aid of a metal sandpaper to facilitate the removal of the biofilm.
  • Procedure: Restoration with composite resin
    In control group, the treatment will be performed after prophylaxis and relative isolation. The selective caries removal will be performed with appropriate dentin curettes, and then the application of the adhesive system and restoration of composite resin will be conducted.
Study Arms  ICMJE
  • Experimental: UTC
    Enlargement of the wells with metal sandpaper.
    Intervention: Procedure: UCT
  • Active Comparator: Restoration with composite resin
    Selective caries removal and restoration with composite resin.
    Intervention: Procedure: Restoration with composite resin
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: April 20, 2019)
196
Original Estimated Enrollment  ICMJE
 (submitted: December 21, 2018)
162
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children will be included that have at least one anterior tooth with carious lesion cavitated affecting the proximal surface.

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 lesions affecting more than one third of the vestibular / palatine / lingual surfaces, with a prior history of trauma, presenting pulp exposure, spontaneous pain, mobility, presence of abscess or fistula next to the tooth, teeth with restorations, enamel formation defects or with physiological mobility (exfoliation) will also be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 6 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 NCT03785730
Other Study ID Numbers  ICMJE Unib3
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