Partial Removal of Caries Dentines

Study Overview
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Brief Summary
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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.

Official Title
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Alternative Treatment of Deep Caries Lesions Based on Biological Evidences

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Partial removal of carious dentine
* Procedure: Stepwise excavation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: Partial removal of carious dentine<br>* 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<br>|
| Active Comparator: 2<br>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). | Procedure: Stepwise excavation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulp sensitivity |  | Once a year during at least five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep caries lesion, dentine caries removal, dental restoration, stepwise excavation