NCT00887952

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
329

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2009

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 30, 2009

Status Verified

April 1, 2009

Enrollment Period

3.3 years

First QC Date

April 22, 2009

Last Update Submit

December 29, 2009

Conditions

Dental Caries

Keywords

Deep caries lesiondentine caries removaldental restorationstepwise excavation

Outcome Measures

Primary Outcomes (1)

  • Pulp sensitivity

    Once a year during at least five years

Secondary Outcomes (3)

  • Remineralization of the residual caries (measure through digital substraction of radiographic exams)

    Once a year during at least five years

  • Cost-effectiveness analysis

    During five years of follow-up

  • Clinical evaluation of amalgam and resin restorations (USPHS criteria)

    Once a year during at least five years

Study Arms (2)

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

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

Interventions

Partial removal of carious dentinePROCEDURE

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

1
Stepwise excavationPROCEDURE

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.

2

Eligibility Criteria

Age9 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • subjects with general diseases affecting their caries experience;
  • caries lesion evolving an entire cusp;
  • caries lesion with cervical margin in dentine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Odontology Faculty - Federal University of Brasília

Brasília, Federal District, Brazil

Location

Odontology Faculty - Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Related Publications (10)

  • 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.

    PMID: 17921671BACKGROUND

  • 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.

    PMID: 16550396BACKGROUND

  • 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.

    PMID: 11890029BACKGROUND

  • 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.

    PMID: 9448347BACKGROUND

  • 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.

    PMID: 18565369BACKGROUND

  • 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.

    PMID: 11093026BACKGROUND

  • 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.

    PMID: 9645406BACKGROUND

  • 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.

    PMID: 16856019BACKGROUND

  • 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.

    PMID: 32585263DERIVED

  • 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.

    PMID: 22983407DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Officials

  • Marisa Maltz, PhD

    Odontology Faculty - Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 22, 2009

First Posted

April 24, 2009

Study Start

August 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2010

Last Updated

December 30, 2009

Record last verified: 2009-04

Locations

BR(2)