Partial Removal of Caries Dentines (PRCD)

Federal University of Rio Grande do Sul

Status: Unknown

Conditions: Dental Caries

Treatments: Procedure: Partial removal of carious dentine; Procedure: Stepwise excavation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00887952

FAPERGS 04/1531.8

FO UFRGS

CNPQ 403420/04

Details and patient eligibility

About

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.

Enrollment: 329 patients

Sex: All

Ages: 9 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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329 participants in 2 patient groups

1

Experimental group

Description:

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.

Treatment:

Procedure: Partial removal of carious dentine

2

Active Comparator group

Description:

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).

Treatment:

Procedure: Stepwise excavation