Efficacy of Hall Technique in Atypical Lesions on Primary Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Atypical carious cavities could be defined as carious lesions in more than 2 surfaces of the
      same tooth. Dental practitioners have shown difficulties related to material's maintenance in
      such type of cavities and therefore, several treatment options have been used. However, most
      of them have shown a great failure percentage. A randomized clinical trial will be developed
      with the objective of assessing the Hall technique in comparison with the composite resin
      incremental technique in 364 primary molars' atypical carious lesions of children between 4
      and 9 years old. Initially, two previously calibrated examiners will perform caries diagnosis
      by means of visual assessment and intraoral examination. Selected teeth will be randomly
      allocated into two groups. Teeth in the first group will be submitted to prefabricated
      stainless steel crowns treatment (Hall technique); and the other, to composite resin
      incremental technique, which will be always placed under rubber dam isolation. Lesions'
      clinical and radiographic follow-up will be conducted after 6 and 12 months.

      Treatment's efficacy will be assessed by means of four main outcomes:

        1. Longevity, marginal adaptation, possible modification in patients' vertical dimension,
           and caries lesion progression;

        2. Patient-focused criteria (satisfaction, discomfort and quality of life impact);

        3. cost-efficacy; and

        4. Treatment-related parents', children' and operators' perception.

      Other variables could be further analysed as secondary outcomes, such as techniques
      performing time among operators, impact of the socio-economic characteristics on
      restorations' longevity, and restorations' type impact on the antagonist tooth. Comparisons
      between groups will be addressed using the Kaplan-Meier survival test as well as Long-Rank
      test. Cox Regression will be used to enable the assessment of other variables' influence in
      the results. Significance value of 5% will be adopted for all analysis.
    


Intervention name(s): Dental Restoration with Stainless Crown; Dental Restoration with Composite Resin
Intervention type(s): Other; Other
Intervention description(s): Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans & Innes, 2010).; Surfaces allocated to this group will be treated with composite resin (Z250, 3M ESPE, USA) according to the manufacturer's instructions.
Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 15 seconds, followed by spray of water/air for at least 15 seconds. Then, the adhesive system (Single Bond, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions. Finally, composite resin (Z250, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stainless dental crown; Composite Resin; Primary teeth