Partial Removal of Caries Dentines (PRCD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Federal University of Rio Grande do Sul.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ivoclar Vivadent AG
Information provided by:
Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00887952
First received: April 22, 2009
Last updated: December 29, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Dental Caries
Procedure: Partial removal of carious dentine
Procedure: Stepwise excavation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Alternative Treatment of Deep Caries Lesions Based on Biological Evidences

Resource links provided by NLM:


Further study details as provided by Federal University of Rio Grande do Sul:

Primary Outcome Measures:
  • Pulp sensitivity [ Time Frame: Once a year during at least five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Remineralization of the residual caries (measure through digital substraction of radiographic exams) [ Time Frame: Once a year during at least five years ] [ Designated as safety issue: No ]
  • Cost-effectiveness analysis [ Time Frame: During five years of follow-up ] [ Designated as safety issue: No ]
  • Clinical evaluation of amalgam and resin restorations (USPHS criteria) [ Time Frame: Once a year during at least five years ] [ Designated as safety issue: No ]

Enrollment: 329
Study Start Date: August 2005
Estimated Study Completion Date: November 2010
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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: 2
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
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.

  Eligibility

Ages Eligible for Study:   9 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887952

Locations
Brazil
Odontology Faculty - Federal University of Brasília
Brasília, Distrito Federal, Brazil
Odontology Faculty - Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Sponsors and Collaborators
Federal University of Rio Grande do Sul
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Ivoclar Vivadent AG
Investigators
Principal Investigator: Marisa Maltz, PhD Odontology Faculty - Federal University of Rio Grande do Sul
Study Chair: Heliana Mestrinho, PhD Odontology Faculty - Federal University of Brasília
Study Chair: Lilian M De Paula, PhD Odontology Faculty - Federal University of Brasília
Study Chair: Juliana J Jardim, MSc Odontology Faculty - Federal University of Rio Grande do Sul
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marisa Maltz, Odontology Faculty - Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT00887952     History of Changes
Other Study ID Numbers: FO UFRGS, FAPERGS 04/1531.8, CNPQ 403420/04
Study First Received: April 22, 2009
Last Updated: December 29, 2009
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Rio Grande do Sul:
Deep caries lesion
dentine caries removal
dental restoration
stepwise excavation

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 20, 2014