Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

NCT03933176 | Withdrawn

• 1 other identifier: UFS/Prodonto
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Caries; Dentin; Dental Restoration Failure of Marginal Integrity

Keywords

Glass ionomer; Bulk-Fill Composite

Outcome Measures

Primary Outcomes (1)

• Longevity of restoration

  Assessment of any failure in restorations according to the FDI World Dental Federation criteria.

  Annual evaluation during 5 years

Secondary Outcomes (1)

• Tooth sensitivity

  15 days after the restorative procedure

Study Arms (2)

Simplified restorative procedure

EXPERIMENTAL

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).

Procedure: Restoration of carious lesions

Control

ACTIVE COMPARATOR

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.

Procedure: Restoration of carious lesions

Interventions

Restoration of carious lesions PROCEDURE

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

Control; Simplified restorative procedure

Eligibility Criteria

• Age: 6 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Molar presenting deep carious lesion;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Sergipe: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Federal University of Pelotas: collaborator
• University of Brasilia: collaborator
• Universidade Federal do Ceara: collaborator
• Federal University of Uberlandia: collaborator
• Universidade Veiga de Almeida: collaborator

Study Sites (1)

Department of Dentistry/ Federal University of Sergipe

Aracaju, Sergipe, 49060100, Brazil

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 26, 2019
• First Posted: May 1, 2019
• Study Start: June 30, 2019
• Primary Completion: November 1, 2020
• Study Completion: September 1, 2024
• Last Updated: June 22, 2023

Record last verified: 2023-06

Locations

BR (1)