Overview

This trial is active, not recruiting.

Condition dental caries
Treatments partial removal of carious dentine, stepwise excavation
Sponsor Federal University of Rio Grande do Sul
Collaborator Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Start date August 2005
End date November 2008
Trial size 329 participants
Trial identifier NCT00887952, CNPQ 403420/04, FAPERGS 04/1531.8, FO UFRGS

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
partial removal of carious dentine
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
(Active Comparator)
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).
stepwise excavation
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.

Primary Outcomes

Measure
Pulp sensitivity
time frame: Once a year during at least five years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 9 years up to 45 years old.

Inclusion Criteria: - patients ≥ nine years old; - permanent molars with primary deep caries lesion reaching dentine inner half (radiographic exam); - pulpal sensibility positive (cold test); - absence of spontaneous pain; - absence of periapical alterations (radiographic exam); - negative percussion test. Exclusion Criteria: - subjects with general diseases affecting their caries experience; - caries lesion evolving an entire cusp; - caries lesion with cervical margin in dentine.

Additional Information

Official title Alternative Treatment of Deep Caries Lesions Based on Biological Evidences
Principal investigator Marisa Maltz, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2009.
Information provided to ClinicalTrials.gov by Federal University of Rio Grande do Sul.