Partial Removal of Caries Dentines (PRCD)
Primary Purpose
Dental Caries
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Partial removal of carious dentine
Stepwise excavation
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries focused on measuring Deep caries lesion, dentine caries removal, dental restoration, stepwise excavation
Eligibility 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.
Sites / Locations
- Odontology Faculty - Federal University of Brasília
- Odontology Faculty - Federal University of Rio Grande do Sul
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
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.
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).
Outcomes
Primary Outcome Measures
Pulp sensitivity
Secondary Outcome Measures
Remineralization of the residual caries (measure through digital substraction of radiographic exams)
Cost-effectiveness analysis
Clinical evaluation of amalgam and resin restorations (USPHS criteria)
Full Information
NCT ID
NCT00887952
First Posted
April 22, 2009
Last Updated
December 29, 2009
Sponsor
Federal University of Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ivoclar Vivadent AG
1. Study Identification
Unique Protocol Identification Number
NCT00887952
Brief Title
Partial Removal of Caries Dentines
Acronym
PRCD
Official Title
Alternative Treatment of Deep Caries Lesions Based on Biological Evidences
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Unknown status
Study Start Date
August 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Federal University of Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Ivoclar Vivadent AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
Deep caries lesion, dentine caries removal, dental restoration, stepwise excavation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
329 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Arm Title
2
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
Partial removal of carious dentine
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Stepwise excavation
Intervention Description
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 Outcome Measure Information:
Title
Pulp sensitivity
Time Frame
Once a year during at least five years
Secondary Outcome Measure Information:
Title
Remineralization of the residual caries (measure through digital substraction of radiographic exams)
Time Frame
Once a year during at least five years
Title
Cost-effectiveness analysis
Time Frame
During five years of follow-up
Title
Clinical evaluation of amalgam and resin restorations (USPHS criteria)
Time Frame
Once a year during at least five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marisa Maltz, PhD
Organizational Affiliation
Odontology Faculty - Federal University of Rio Grande do Sul
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Heliana Mestrinho, PhD
Organizational Affiliation
Odontology Faculty - Federal University of Brasília
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Lilian M De Paula, PhD
Organizational Affiliation
Odontology Faculty - Federal University of Brasília
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Juliana J Jardim, MSc
Organizational Affiliation
Odontology Faculty - Federal University of Rio Grande do Sul
Official's Role
Study Chair
Facility Information:
Facility Name
Odontology Faculty - Federal University of Brasília
City
Brasília
State/Province
Distrito Federal
Country
Brazil
Facility Name
Odontology Faculty - Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-003
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
17921671
Citation
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. doi: 10.1159/000109349. Epub 2007 Oct 5.
Results Reference
background
PubMed Identifier
16550396
Citation
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. doi: 10.1007/s00784-006-0033-8. Epub 2006 Mar 21.
Results Reference
background
PubMed Identifier
11890029
Citation
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.
Results Reference
background
PubMed Identifier
9448347
Citation
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. doi: 10.14219/jada.archive.1998.0022.
Results Reference
background
PubMed Identifier
18565369
Citation
Bjorndal L. Indirect pulp therapy and stepwise excavation. J Endod. 2008 Jul;34(7 Suppl):S29-33. doi: 10.1016/j.joen.2008.02.035.
Results Reference
background
PubMed Identifier
11093026
Citation
Bjorndal 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. doi: 10.1159/000016631.
Results Reference
background
PubMed Identifier
9645406
Citation
Bjorndal 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. doi: 10.1111/j.1600-0528.1998.tb01938.x.
Results Reference
background
PubMed Identifier
16856019
Citation
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. doi: 10.1002/14651858.CD003808.pub2.
Results Reference
background
PubMed Identifier
32585263
Citation
Jardim JJ, Mestrinho HD, Koppe B, de Paula LM, Alves LS, Yamaguti PM, Almeida JCF, Maltz M. Restorations after selective caries removal: 5-Year randomized trial. J Dent. 2020 Aug;99:103416. doi: 10.1016/j.jdent.2020.103416. Epub 2020 Jun 22.
Results Reference
derived
PubMed Identifier
22983407
Citation
Maltz M, Garcia R, Jardim JJ, de Paula LM, Yamaguti PM, Moura MS, Garcia F, Nascimento C, Oliveira A, Mestrinho HD. Randomized trial of partial vs. stepwise caries removal: 3-year follow-up. J Dent Res. 2012 Nov;91(11):1026-31. doi: 10.1177/0022034512460403. Epub 2012 Sep 14.
Results Reference
derived
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Partial Removal of Caries Dentines
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