An interventional study of Partial removal of carious dentine and Stepwise excavation in Dental Caries, sponsored by Federal University of Rio Grande do Sul. Status unknown at 2 sites in Brazil. Open to participants aged 9 Years to 45 Years. Per ClinicalTrials.gov, last updated 2009-12-30.
Sponsored by Federal University of Rio Grande do Sul · Not applicable, Interventional, and Treatment
The aim of this multicenter randomized controlled clinical trial is to evaluate the effectiveness of an alternative treatment for deep caries lesions in Public Health Services. The alternative treatment consists of partial removal of carious dentine followed by restoration. The subjects were assigned to test or control groups: test - carious dentine partial removal and restoration in one session, and control - stepwise excavation. The stepwise excavation consists of partial removal of carious tissue from the cavity floor, indirect pulp capping with calcium hydroxide cement; temporary filling; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling. Each group was divided according to the filling material: amalgam or resin. The radiological exams are being performed before and after the treatment and then annually. Clinical evaluation of the restorations is performed right after the treatment and then annually (modified USPHS System). All evaluations are performed by calibrated and trained dentists.
1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.
This study's enrollment of 329 is above the median of 60 across 916 interventional studies indexed under Dental Caries.
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Exclusion Criteria:
Partial removal of carious dentine. Carious dentine partial removal plus restoration in one session. The group is divided according to the filling material: amalgam or resin.
Procedure: Partial removal of carious dentine
Stepwise excavation: Carious dentine removal performed in 2 steps: partial removal of carious dentine, indirect pulp capping (calcium hydroxide cement); temporary filling with IRM; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling (amalgam or resin).
Procedure: Stepwise excavation
All procedures will be carrying out under local anesthesia and rubber dam. The treatment will be performed as follow: access to the lesion using rotator instruments (if necessary); fully removal of carious tissue from the cavity walls according to hardness criteria by rotator instruments and/or hand excavator; removal of the necrotic carious tissue (soft and disorganized carious tissue) from the cavity floor by hand excavator (to avoid pulp exposure); cleaning with distilled water and drying with sterile filter paper; group randomization. If the tooth is assigned to test group: cavity floor covered with calcium hydroxide cement; restoration using amalgam or steel crown following their usual clinical procedures based on the instructions of the manufacturer
The treatment will be performed as follow: access to the lesion using rotator instruments (if necessary); fully removal of carious tissue from the cavity walls according to hardness criteria by rotator instruments and/or hand excavator; removal of the necrotic carious tissue (soft and disorganized carious tissue) from the cavity floor by hand excavator (to avoid pulp exposure); cleaning with distilled water and drying with sterile filter paper; group randomization. If the tooth is assigned to SE: indirect pulp capping with calcium hydroxide cement; temporary filling with IRM; cavity re-opening after 60 days, removal of the remaining soft carious tissue and filling following the same procedures described to test group.
Pulp sensitivity
Time frame: Once a year during at least five years
Remineralization of the residual caries (measure through digital substraction of radiographic exams)
Time frame: Once a year during at least five years
Cost-effectiveness analysis
Time frame: During five years of follow-up
Clinical evaluation of amalgam and resin restorations (USPHS criteria)
Time frame: Once a year during at least five years
This study is status unknown, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.
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Federal University of Rio Grande do Sul