Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03933176

Acronym

(ALFSCaRe)

Enrollment

Registered

2019-05-01

Start date

2019-06-30

Completion date

2024-09-30

Last updated

2023-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries; Dentin, Dental Restoration Failure of Marginal Integrity

Keywords

Glass ionomer, Bulk-Fill Composite

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.

Interventions

PROCEDURERestoration of carious lesions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

6 Years to 40 Years

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026