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Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Not Applicable
Withdrawn
Conditions
Caries; Dentin
Dental Restoration Failure of Marginal Integrity
Registration Number
NCT03933176
Lead Sponsor
Universidade Federal de Sergipe
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Longevity of restorationAnnual evaluation during 5 years

Assessment of any failure in restorations according to the FDI World Dental Federation criteria.

Secondary Outcome Measures
NameTimeMethod
Tooth sensitivity15 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.

Trial Locations

Locations (1)

Department of Dentistry/ Federal University of Sergipe

🇧🇷

Aracaju, SE, Brazil

Department of Dentistry/ Federal University of Sergipe
🇧🇷Aracaju, SE, Brazil

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