Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Sponsor

Universidade Federal de Sergipe (Other)

Overall Status

Recruiting

CT.gov ID

NCT03933176

Collaborator

Conselho Nacional de Desenvolvimento Científico e Tecnológico (Other), Federal University of Pelotas (Other), University of Brasilia (Other), Universidade Federal do Ceara (Other), Federal University of Uberlandia (Other), Universidade Veiga de Almeida (Other)

340

Enrollment

Location

Arms

62.1

Anticipated Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries; Dentin Dental Restoration Failure of Marginal Integrity	Procedure: Restoration of carious lesions	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

340 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 30, 2019

Actual Primary Completion Date :

Nov 1, 2020

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Longevity of restoration [Annual evaluation during 5 years]
Assessment of any failure in restorations according to the FDI World Dental Federation criteria.

Secondary Outcome Measures

Tooth sensitivity [15 days after the restorative procedure]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Dentistry/ Federal University of Sergipe	Aracaju	SE	Brazil	49060100

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

André Luis Faria e Silva, Professor, Universidade Federal de Sergipe

ClinicalTrials.gov Identifier:

NCT03933176

Other Study ID Numbers:

UFS/Prodonto

First Posted:

May 1, 2019

Last Update Posted:

Nov 12, 2020

Last Verified:

Nov 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by André Luis Faria e Silva, Professor, Universidade Federal de Sergipe

Glass ionomer

Bulk-Fill Composite

Study Results

No Results Posted as of Nov 12, 2020