Trial record 16 of 63 for:    dental [CONDITION] AND child [AGE-GROUP] | Open Studies

Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth (CARDEC-1)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by University of Sao Paulo
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Fausto Medeiros Mendes, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT02078453
First received: February 25, 2014
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Dental Caries
Teeth Loss
Quality of Life
Procedure: Dental treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: CARies DEtection in Children - Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Number of dental surfaces with operative treatment needs [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Number of surfaces with new caries lesions [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Dental surfaces presenting caries lesions in the foloow-up examinations that require operative treatment.

  • Number of restored surfaces with necessity of replacement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of restored dental surfaces that requires repair or replacement.

  • Episodes of dental pain and/or primary teeth with pulpal involvement [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of primary teeth that presented pain episodes or that require endodontic treatment in the follow-up examinations

  • Primary teeth indicated for extraction due to caries [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Number of primary teeth indicated for extraction due caries involvment.


Other Outcome Measures:
  • Impact of Oral Health on quality of life [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Impact of Oral Health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS)


Estimated Enrollment: 250
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Visual inspection
Dental treatment performed according to the caries diagnosis obtained with visual inspection performed alone
Procedure: Dental treatment
Dental treatment of all dental needs present in the children related or not to the dental caries.
Experimental: Radiographic examination
Dental treatment performed according to the caries diagnosis obtained with visual inspection and additional radiographic method.
Procedure: Dental treatment
Dental treatment of all dental needs present in the children related or not to the dental caries.

Detailed Description:

Despite most clinical guidelines throughout the world indicate that the clinicians take two bitewings for detecting caries lesions in primary molars of asymptomatic children, the evidence for this recommendation is based in cross-sectional studies performed in laboratorial setting or using convenience samples. The benefits and impact of performing radiographs on diagnosis and treatment decision of caries lesions in primary teeth, considering relevant outcomes for the patients, have not been evaluated yet. Thus, the aim of this study will be to evaluate the impact of performing radiographic examination for detecting caries lesions in primary teeth compared with the visual inspection performed alone, considering different outcomes related to the validity and children's health and welfare. For this, three different studies will be carried out according the following specific aims: (1) to evaluate the validity of radiographic examination adjunct to the visual inspection in detecting proximal caries lesions in primary molars in children with low and high caries experience through a cross-sectional design; (2) to evaluate the impact of radiographic examination adjunct to the visual inspection on the diagnostic and treatment decision of caries lesions in primary teeth in a before and after study; and (3) to evaluate the impact of radiographic examination adjunct to the visual inspection for detecting caries lesions in primary teeth on operative needs in the follow-ups and impact of oral health on the quality of life through a randomized clinical trial. To reach these objectives, 250 children aged 3 to 6 years who looked for dental treatment in our dental school will be randomly allocated in two groups according to the diagnostic strategy used for caries detection: visual inspection performed alone (control group) or visual inspection associated to radiographic examination (experimental group). After elaboration of treatment decision plan for two examiners, the children will be treated and followed-up for 2 years, with evaluations after 12 and 24 months after the ingress of the children in the study. The primary outcome will be the number of dental surfaces with dental treatment need in the follow-up, considering the aim (3). Then, children allocated in the control group will be reevaluated using radiographic examination, and the performance of two strategies for detecting proximal caries lesions will be evaluated, using temporary separation with orthodontic rubbers for one week as reference standard method. Moreover, a new treatment plan will be performed and compared with the treatment plan based on visual inspection alone. These two parts of the research will be carried out to reach the aims (1) and (2), respectively. Our working hypothesis is that the radiographic examination would actually exert little influence on outcomes related to the validity and children's health and welfare, and that visual inspection would be enough as diagnostic strategy for caries detection in primary teeth.

  Eligibility

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Children whose parents refuse to participate of the research
  • Children presenting behavior problems during the treatment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02078453

Contacts
Contact: Fausto M Mendes, PhD +55 11 3091-78-35 fmmendes@usp.br
Contact: Tatiane F Novaes, PhD +55 11 3091-7835 tatifn@usp.br

Locations
Brazil
School of Dentistry, University of Sao Paulo Not yet recruiting
Sao Paulo, Brazil, 05508-000
Contact: Fausto M Mendes, PhD    +55 11 3091-7835    fmmendes@usp.br   
Contact: Tatiane F Novaes, PhD    +55 11 3091-7835    tatifn@usp.br   
Sponsors and Collaborators
University of Sao Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Investigators
Principal Investigator: Fausto M Mendes, PhD School of Dentistry, University of Sao Paulo
  More Information

No publications provided

Responsible Party: Fausto Medeiros Mendes, Associate professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02078453     History of Changes
Other Study ID Numbers: CARDEC-01
Study First Received: February 25, 2014
Last Updated: March 3, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Dental caries
Diagnosis
Visual inspection
Radiographic examination

Additional relevant MeSH terms:
Dental Caries
Tooth Loss
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases

ClinicalTrials.gov processed this record on July 20, 2014