Partial Removal of Caries Dentines

Dental Caries Clinical Trial

— PRCD  

Official title:

Alternative Treatment of Deep Caries Lesions Based on Biological Evidences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00887952
• Other study ID #: FO UFRGS
• Secondary ID: FAPERGS 04/1531.
• Status: Active, not recruiting
• Phase: N/A
• First received: April 22, 2009
• Last updated: December 29, 2009
• Start date: August 2005
• Est. completion date: November 2010

Study information

• Verified date: April 2009
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 329
• Est. completion date: November 2010
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

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
• 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.

Locations

Country	Name	City	State
Brazil	Odontology Faculty - Federal University of Brasília	Brasília	Distrito Federal
Brazil	Odontology Faculty - Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul

Sponsors (4)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil, Ivoclar Vivadent AG

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View Citation

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. — View Citation

Bjørndal L. Indirect pulp therapy and stepwise excavation. J Endod. 2008 Jul;34(7 Suppl):S29-33. doi: 10.1016/j.joen.2008.02.035. Review. — View 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. — View 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. Epub 2007 Oct 5. — View 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. — View 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. Epub 2006 Mar 21. — View 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. Review. Update in: Cochrane Database Syst Rev. 2013;3:CD003808. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulp sensitivity		Once a year during at least five years	No
Secondary	Remineralization of the residual caries (measure through digital substraction of radiographic exams)		Once a year during at least five years	No
Secondary	Cost-effectiveness analysis		During five years of follow-up	No
Secondary	Clinical evaluation of amalgam and resin restorations (USPHS criteria)		Once a year during at least five years	No

External Links

•   Website where the results of the study are being recorded.