Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth
Condition: Dental Caries; Teeth Loss; Quality of Life
MeSH terms: Dental Caries; Tooth Loss
Study type: Interventional

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.
    

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.
    

Intervention name(s): Dental treatment
Intervention type(s): Procedure
Intervention description(s): Dental treatment of all dental needs present in the children related or not to the dental caries.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Dental caries; Diagnosis; Visual inspection; Radiographic examination