Absence of Liner Following the Selective Caries Removal (ALFSCaRe) ((ALFSCaRe))

Is the Use of a Glass Ionomer Liner Necessary After Selective Carious Tissue Removal?

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.

Study Overview

• Status: Withdrawn
• Conditions: Dental Restoration Failure of Marginal Integrity; Caries; Dentin
• Intervention / Treatment: Procedure: Restoration of carious lesions

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SE
    • Aracaju, SE, Brazil, 49060100
      • Department of Dentistry/ Federal University of Sergipe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 40 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Procedure: Restoration of carious lesions; Selective carious tissue removal followed by restoration of the cavity using composite resin.
Active Comparator: 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.	Procedure: Restoration of carious lesions; Selective carious tissue removal followed by restoration of the cavity using composite resin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Longevity of restoration	Assessment of any failure in restorations according to the FDI World Dental Federation criteria.	Annual evaluation during 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth sensitivity	The participants will self-assess their level of tooth sensitivity of the restored teeth using a visual analogue scale of 0-10 (0 indicating absence of pain; and 10 the worst pain possible) oriented by both verbal description and Wong-Baker facial grimace scales.	15 days after the restorative procedure

Collaborators and Investigators

• Sponsor: Universidade Federal de Sergipe
• Collaborators: University of Brasilia; Conselho Nacional de Desenvolvimento Científico e Tecnológico; Federal University of Pelotas; Federal University of Uberlandia; Universidade Veiga de Almeida; Universidade Federal do Ceará

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2019
• Primary Completion (Actual): November 1, 2020
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 20, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Glass ionomer; Bulk-Fill Composite
• Other Study ID Numbers: UFS/Prodonto

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No