Clinical trial NCT00887952: Partial Removal of Caries Dentines
Official title: Alternative Treatment of Deep Caries Lesions Based on Biological Evidences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Keywords: Deep caries lesion
dentine caries removal
dental restoration
stepwise excavation
Lead sponsor: Federal University of Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Ivoclar Vivadent AG
First posted: 2009-04-24
Enrollment: 329
Sex: ALL
Minimum age (years): 9
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pulp sensitivity
timeFrame: Once a year during at least five years
Secondary outcomes:
measure: Remineralization of the residual caries (measure through digital substraction of radiographic exams)
timeFrame: Once a year during at least five years
measure: Cost-effectiveness analysis
timeFrame: During five years of follow-up
measure: Clinical evaluation of amalgam and resin restorations (USPHS criteria)
timeFrame: Once a year during at least five years
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Odontology Faculty - Federal University of Brasília
state: Distrito Federal
city: Porto Alegre
country: Brazil
facility: Odontology Faculty - Federal University of Rio Grande do Sul
state: Rio Grande do Sul
Study officials:
affiliation: Odontology Faculty - Federal University of Rio Grande do Sul
name: Marisa Maltz, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Odontology Faculty - Federal University of Brasília
name: Heliana Mestrinho, PhD
role: STUDY_CHAIR
affiliation: Odontology Faculty - Federal University of Brasília
name: Lilian M De Paula, PhD
role: STUDY_CHAIR
affiliation: Odontology Faculty - Federal University of Rio Grande do Sul
name: Juliana J Jardim, MSc
role: STUDY_CHAIR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.