Partial Removal of Caries Dentines - Full Text View

Sponsors and Collaborators:	Federal University of Rio Grande do Sul FAPERGS CNPq Ivoclar Vivadent
Information provided by:	Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier:	NCT00887952

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Alternative Treatment of Deep Caries Lesions Based on Biological Evidences

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
1: 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.	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
2: 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).	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.

Arms

Assigned Interventions

1: 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.

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

2: 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).

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

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

Locations

Brazil, Distrito Federal
Odontology Faculty - Federal University of Brasília
Brasília, Distrito Federal, Brazil
Brazil, Rio Grande do Sul
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

FAPERGS

CNPq

Ivoclar Vivadent

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:

Website where the results of the study are being recorded. This link exits the ClinicalTrials.gov site

Publications:

Maltz M, Oliveira EF, Fontanella V, Carminatti G. Deep caries lesions after incomplete dentine caries removal: 40-month follow-up study. Caries Res. 2007;41(6):493-6. Epub 2007 Oct 5.

Oliveira EF, Carminatti G, Fontanella V, Maltz M. The monitoring of deep caries lesions after incomplete dentine caries removal: results after 14-18 months. Clin Oral Investig. 2006 Jun;10(2):134-9. Epub 2006 Mar 21.

Maltz M, de Oliveira EF, Fontanella V, Bianchi R. A clinical, microbiologic, and radiographic study of deep caries lesions after incomplete caries removal. Quintessence Int. 2002 Feb;33(2):151-9.

Mertz-Fairhurst EJ, Curtis JW Jr, Ergle JW, Rueggeberg FA, Adair SM. Ultraconservative and cariostatic sealed restorations: results at year 10. J Am Dent Assoc. 1998 Jan;129(1):55-66.

Bjørndal L. Indirect pulp therapy and stepwise excavation. J Endod. 2008 Jul;34(7 Suppl):S29-33. Review.

Bjørndal L, Larsen T. Changes in the cultivable flora in deep carious lesions following a stepwise excavation procedure. Caries Res. 2000 Nov-Dec;34(6):502-8.

Bjørndal L, Thylstrup A. A practice-based study on stepwise excavation of deep carious lesions in permanent teeth: a 1-year follow-up study. Community Dent Oral Epidemiol. 1998 Apr;26(2):122-8.

Ricketts DN, Kidd EA, Innes N, Clarkson J. Complete or ultraconservative removal of decayed tissue in unfilled teeth. Cochrane Database Syst Rev. 2006 Jul 19;3:CD003808. Review.

Responsible Party:	Odontology Faculty - Federal University of Rio Grande do Sul ( Marisa Maltz )
Study ID Numbers:	FO UFRGS, FAPERGS 04/1531.8, CNPQ 403420/04
Study First Received:	April 22, 2009
Last Updated:	April 22, 2009
ClinicalTrials.gov Identifier:	NCT00887952 History of Changes
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

Study placed in the following topic categories:

Calcium, Dietary
Tooth Diseases
Anesthetics
Stomatognathic Diseases
Dental Caries

Additional relevant MeSH terms:

Tooth Diseases
Stomatognathic Diseases
Tooth Demineralization
Dental Caries

ClinicalTrials.gov processed this record on May 06, 2009