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Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

U

Universidade Federal de Sergipe

Status

Withdrawn

Conditions

Caries; Dentin
Dental Restoration Failure of Marginal Integrity

Treatments

Procedure: Restoration of carious lesions

Study type

Interventional

Funder types

Other

Identifiers

NCT03933176
UFS/Prodonto

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

0 participants in 2 patient groups

Simplified restorative procedure
Experimental group
Description:
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).
Treatment:
Procedure: Restoration of carious lesions
Control
Active Comparator group
Description:
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.
Treatment:
Procedure: Restoration of carious lesions

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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