Clinical trial NCT02782390: Efficacy of Hall Technique in Atypical Lesions on Primary Teeth
Official title: Efficacy of Hall Technique in Atypical Lesions on Primary Teeth: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Keywords: Stainless dental crown
Composite Resin
Primary teeth
Lead sponsor: Faculty Sao Leopoldo Mandic Campinas
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 364
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* children must have at least one molar with atypical caries lesion (involving more than two surfaces);
* parents or legal guardians accept and sign the informed consent form.

Exclusion Criteria:

* children with special needs and/or systematic diseases with oral impairment;
* teeth with spontaneous painful symptoms or necrotized and teeth presenting restorations, sealants, developmental enamel defects, pulp exposure or other signs related to endodontic treatment.

Primary outcomes:
measure: Clinical longevity of restoration
timeFrame: Change from baseline until 6 and 12 months
Secondary outcomes:
measure: Change in patient's vertical dimension
timeFrame: Baseline, 30 days, 6 and 12 months
measure: Antagonist's level of intrusion
timeFrame: Baseline, 6 and 12 months
measure: Treatments' cost-efficacy
timeFrame: Through study completion (12 months)
measure: Clinical caries lesion progression
timeFrame: Baseline, 6 and 12 months
measure: Impact on children's quality of life (4-5 years old)
timeFrame: Baseline and 6 months
measure: Impact on children's quality of life (6-9 years old)
timeFrame: Baseline and 6 months
measure: Children's perceptions about the treatment
timeFrame: Baseline, 6 and 12 months
measure: Children's satisfaction with the treatment
timeFrame: Baseline and 6 months
measure: Children self-reported discomfort
timeFrame: Baseline
measure: Marginal adaptation of the stainless steel crowns
timeFrame: Baseline, 6 and 12 months
measure: Radiographical caries lesion progression
timeFrame: Baseline, 6 and 12 months
measure: Biofilm retention of the stainless steel crowns
timeFrame: Baseline, 6 and 12 months
measure: Caregivers' perceptions about the treatment
timeFrame: Baseline, 6 and 12 months
measure: Clinicians' perceptions about the treatment
timeFrame: Baseline, 6 and 12 months
measure: Caregivers' satisfaction with the treatment
timeFrame: Baseline and 6 months
measure: Clinicians' satisfaction with the treatment
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Faculdade Sao Leopoldo Mandic
state: SP
Study officials:
affiliation: Faculty Sao Leopoldo Mandic
name: Jose Carlos P Imparato, Professor
role: PRINCIPAL_INVESTIGATOR
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