Partial Removal of Caries Dentines

Not Applicable

• Conditions: Dental Caries
• Interventions: Procedure: Partial removal of carious dentine; Procedure: Stepwise excavation

• Registration Number: NCT00887952
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-08
• Primary Completion: 2008-11
• Status Verified: 2009-04
• Study First Submitted: 2009-04-22
• Study First Submitted QC: 2009-04-22
• Study First Posted: 2009-04-24
• Last Update Submitted: 2009-12-29
• Last Update Posted: 2009-12-30
• Study Completion: 2010-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 329

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Partial removal of carious dentine	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.
2	Stepwise excavation	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).

Primary Outcome Measures

Name	Time	Method
Pulp sensitivity	Once a year during at least five years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

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, Brazil