Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-30

Study Completion Date

2024-09-30

Brief Summary

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This randomized, multi-centric, controlled clinical trial will assess the effectiveness of a simplified restorative protocol used after the selective carious tissue removal in posterior teeth presenting deep carious lesions. Only a regular bulk-fill composite will be used in the simplified restorative protocol following the application of universal adhesive. A liner with resin-modified glass ionomer will be used over the pulpal floor before the composite placement in the control group. The longevity of restorative procedures and post-operative sensitivity were defined as the main and secondary outcomes.

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Detailed Description

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Conditions

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Caries; Dentin Dental Restoration Failure of Marginal Integrity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Simplified restorative procedure

After selective carious tissue removal, the universal adhesive (Adper Universal; 3M ESPE, St. Paul, MN, EUA) will be applied on the cavity walls. The cavity will be restored using a single increment of Filtek One Bulk Fill (3M ESPE, St. Paul, MN, EUA).

Group Type EXPERIMENTAL

Restoration of carious lesions

Intervention Type PROCEDURE

Selective carious tissue removal followed by restoration of the cavity using composite resin.

Control

A thin layer of resin-modified glass ionomer (Ionoseal (Voco America Inc., Briarcliff Manor, NY, EUA) will be placed on the pulpal floor of the cavity. Then, the adhesive and composite will be used following the same directions defined for the experimental condition.

Group Type ACTIVE_COMPARATOR

Restoration of carious lesions

Intervention Type PROCEDURE

Selective carious tissue removal followed by restoration of the cavity using composite resin.

Interventions

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Restoration of carious lesions

Selective carious tissue removal followed by restoration of the cavity using composite resin.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Molar presenting deep carious lesion;

Exclusion Criteria

* Non-vital teeth or teeth presenting pulpitis;
* Cavity margins in dentin;
* Presence of non-carious cervical lesions;
* The necessity of restoration involving any cusp replacement.

Minimum Eligible Age

6 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes