MedTrace Logo

Efficacy of Hall Technique in Atypical Lesions on Primary Teeth

NCT02782390 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2022-06-02

No results posted yet for this study

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.

Conditions

  • Dental Caries

Interventions

OTHER

Dental Restoration with Stainless Crown

Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans \& Innes, 2010).

OTHER

Dental Restoration with Composite Resin

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.

Sponsors & Collaborators

  • Faculty Sao Leopoldo Mandic Campinas

    lead OTHER

Principal Investigators

  • Jose Carlos P Imparato, Professor · Faculty Sao Leopoldo Mandic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
9 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-11-30
Completion
2017-12-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02782390 on ClinicalTrials.gov