Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Dental Restoration Failure of Marginal Integrity Clinical Trial

— (ALFSCaRe)  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03933176
• Other study ID #: UFS/Prodonto
• Status: Withdrawn
• Phase: N/A
• Start date: June 30, 2019
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Universidade Federal de Sergipe
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2024
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Caries; Dentin
• Dental Restoration Failure of Marginal Integrity

Intervention

Procedure:
• Restoration of carious lesions
Selective carious tissue removal followed by restoration of the cavity using composite resin.

Locations

Country	Name	City	State
Brazil	Department of Dentistry/ Federal University of Sergipe	Aracaju	SE

Sponsors (7)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Longevity of restoration	Assessment of any failure in restorations according to the FDI World Dental Federation criteria.	Annual evaluation during 5 years
Secondary	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