Status:
SUSPENDED
Non-restorative Cavity Control in Anterior Cavitated Caries Lesion of Primary Teeth
Lead Sponsor:
Universidade Ibirapuera
Conditions:
Dental Caries
Eligibility:
All Genders
3-6 years
Phase:
NA
Brief Summary
Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomi...
Detailed Description
This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1 allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera (UNIB). The othe...
Eligibility Criteria
Inclusion
- Children will be included that have at least one anterior tooth with carious lesion cavitated affecting the proximal surface.
Exclusion
- Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
- Also, teeth with lesions affecting more than one third of the buccal/lingual surfaces, with previous history of dental trauma, presenting pulp exposure, spontaneous pain, pathological mobility, presence of abscess or fistula next to the tooth, teeth with restorations, developmental enamel defects or physiological mobility (exfoliation) will be excluded.
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
148 Patients enrolled
Trial Details
Trial ID
NCT03785730
Start Date
April 30 2019
End Date
December 30 2027
Last Update
May 10 2024
Active Locations (1)
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1
Tamara Kerber Tedesco
São Paulo, São Paulo, Brazil, 04.545-000