NCT02078453

Brief Summary

Radiographs have been used to aid dentists in detecting the presence of cavities in the deciduous teeth of children. This procedure is globally recommended because the conventional clinical examination usually overlooks some cavities. However, the real benefit of performing dental radiographs for this purpose is still unclear. Besides the hazards of ionizing radiation, the radiographs could provoke overtreatment of the children; hence, dentists would tend to restore more teeth than would be really necessary. Nowadays, it is preferable to overlook some cavities than treat the teeth unnecessarily. Therefore, the investigators aimed to perform this study to compare two different strategies for detecting cavities in deciduous teeth of children: one based on clinical examination performed alone and other using radiographs adjunct to the clinical examination. To compare these strategies, the investigators will consider outcomes related to children's health and welfare.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

May 26, 2020

Status Verified

May 1, 2020

Enrollment Period

3.9 years

First QC Date

February 25, 2014

Last Update Submit

May 21, 2020

Conditions

Dental CariesTeeth LossQuality of Life

Keywords

Dental cariesDiagnosisVisual inspectionRadiographic examination

Outcome Measures

Primary Outcomes (1)

  • Number of dental surfaces with operative treatment needs

    The number of dental surfaces with operative treatment needs after the follow-ups will be composed by number of surfaces with new caries lesions; number of restored surfaces with necessity of replacement; tooth with pain episode and/or necessity of endodontic treatment and tooth indicated for extraction.

    24 months

Secondary Outcomes (4)

  • Number of surfaces with new caries lesions

    24 months

  • Number of restored surfaces with necessity of replacement

    24 months

  • Episodes of dental pain and/or primary teeth with pulpal involvement

    24 months

  • Primary teeth indicated for extraction due to caries

    24 months

Other Outcomes (1)

  • Impact of Oral Health on quality of life

    24 months

Study Arms (2)

Visual inspection

ACTIVE COMPARATOR

Dental treatment performed according to the caries diagnosis obtained with visual inspection performed alone

Procedure: Dental treatment

Radiographic examination

EXPERIMENTAL

Dental treatment performed according to the caries diagnosis obtained with visual inspection and additional radiographic method.

Procedure: Dental treatment

Interventions

Dental treatmentPROCEDURE

Dental treatment of all dental needs present in the children related or not to the dental caries.

Radiographic examinationVisual inspection

Eligibility Criteria

Age3 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children who sought dental treatment in our dental school (School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil)
  • Children aged 3 to 6 years
  • Children with al least one primary molar in the mouth.

You may not qualify if:

  • Children whose parents refuse to participate of the research
  • Children presenting behavior problems during the treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Dentistry, University of Sao Paulo

São Paulo, 05508-000, Brazil

Location

Related Publications (6)

  • Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.

    PMID: 28931398RESULT

  • Pontes LRA, Novaes TF, Lara JS, Moro BLP, Gimenez T, Raggio DP, Braga MM, Mendes FM. Impact of the radiographic method on treatment decisions related to dental caries in primary molars: a before-after study. Clin Oral Investig. 2019 Nov;23(11):4075-4081. doi: 10.1007/s00784-019-02844-w. Epub 2019 Feb 18.

    PMID: 30778687RESULT

  • Freitas JG, Pontes LRA, Acosta CP, Novaes TF, Lara JS, Gimenez T, Ardenghi TM, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2-Year randomized clinical trial. Community Dent Oral Epidemiol. 2023 Oct;51(5):804-812. doi: 10.1111/cdoe.12765. Epub 2022 Jun 7.

    PMID: 35670271DERIVED

  • Pontes LRA, Lara JS, Novaes TF, Freitas JG, Gimenez T, Moro BLP, Maia HCM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Negligible therapeutic impact, false-positives, overdiagnosis and lead-time are the reasons why radiographs bring more harm than benefits in the caries diagnosis of preschool children. BMC Oral Health. 2021 Mar 31;21(1):168. doi: 10.1186/s12903-021-01528-w.

    PMID: 33789655DERIVED

  • Pontes LRA, Novaes TF, Lara JS, Gimenez T, Moro BLP, Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Mendes FM. Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study. J Am Dent Assoc. 2020 Jun;151(6):407-415.e1. doi: 10.1016/j.adaj.2020.02.008.

    PMID: 32450979DERIVED

  • Mendes FM, Pontes LR, Gimenez T, Lara JS, de Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Novaes TF; CARDEC Collaborative Group. Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:69. doi: 10.1186/s13063-016-1196-5.

    PMID: 26857821DERIVED

MeSH Terms

Conditions

Dental CariesAnodontiaDisease

Interventions

Dental Care

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesTooth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DentistryDental Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Fausto M Mendes, PhD

    School of Dentistry, University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

February 25, 2014

First Posted

March 5, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

May 26, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)