Efficacy of Hall Technique in Atypical Lesions on Primary Teeth (SLM2078)

Faculty Sao Leopoldo Mandic Campinas

Status

Completed

Conditions

Dental Caries

Treatments

Other: Dental Restoration with Stainless Crown

Other: Dental Restoration with Composite Resin

Study type

Interventional

Funder types

Other

Identifiers

NCT02782390

SLM3

Details and patient eligibility

About

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:

Longevity, marginal adaptation, possible modification in patients' vertical dimension, and caries lesion progression;
Patient-focused criteria (satisfaction, discomfort and quality of life impact);
cost-efficacy; and
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.

Enrollment

364 patients

Sex

All

Ages

4 to 9 years old

Volunteers

No Healthy Volunteers

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.