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Dental CariesPRCDNCT00887952

Partial Removal of Caries Dentines

A study testing Partial removal of carious dentine and Stepwise excavation in people with Dental Caries, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 9 to 45 years
Conditions the study is for
Dental Caries
What is being tested?
Partial removal of carious dentine and Stepwise excavation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
329 participants
Where
2 sitesBrazil
Study dates
Aug 2005to Nov 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 45 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

  • Odontology Faculty - Federal University of Brasília

    Brasília, Federal District

  • Odontology Faculty - Federal University of Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90035-003

Other trials in Brazil

About this study

Official title: Alternative Treatment of Deep Caries Lesions Based on Biological Evidences

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.

Conditions
Dental Caries
Being tested
Partial removal of carious dentine, Stepwise excavation
Keywords
Deep caries lesion, dentine caries removal, dental restoration, stepwise excavation
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Partial removal of carious dentineProcedure or surgery

    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

  • Stepwise excavationProcedure or surgery

    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.

Study groups in NCT00887952
Study groupRoleWhat they receive
1ExperimentalPartial 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.
Receives: Procedure: Partial removal of carious dentine
2Active comparatorStepwise 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).
Receives: Procedure: Stepwise excavation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulp sensitivity

    Measured: Once a year during at least five years

Secondary outcomes (3)

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

    Measured: Once a year during at least five years

  2. Cost-effectiveness analysis

    Measured: During five years of follow-up

  3. Clinical evaluation of amalgam and resin restorations (USPHS criteria)

    Measured: Once a year during at least five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2009 (estimated)
  2. Study startAug 2005
  3. Primary completionNov 2008
  4. Study completionNov 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00887952
Sponsor's protocol ID
FO UFRGS
Other IDs
FAPERGS 04/1531.8, CNPQ 403420/04
Acronym
PRCD
Status last verified
Apr 2009
First submitted
22 Apr 2009
Last updated
30 Dec 2009
Results posted
No
Data monitoring committee
No

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. doi: 10.1159/000109349. Epub 2007 Oct 5.

    PubMed 17921671

  • 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.

    PubMed 16550396

  • 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.

    PubMed 11890029

  • 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.

    PubMed 9448347

  • 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.

    PubMed 18565369

  • 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.

    PubMed 11093026

  • 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.

    PubMed 9645406

  • 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.

    PubMed 16856019

  • 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.

    PubMed 32585263

  • 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.

    PubMed 22983407

Questions about this trial

What is this clinical trial studying?

A study testing Partial removal of carious dentine and Stepwise excavation in people with Dental Caries, run by Federal University of Rio Grande do Sul at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pulp sensitivity (time frame: Once a year during at least five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00887952, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2009.

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