Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Not Applicable

Withdrawn

• Conditions: Caries; Dentin; Dental Restoration Failure of Marginal Integrity
• Interventions: Procedure: Restoration of carious lesions

• 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

Study Timeline

• Study First Submitted: 2019-04-26
• Study First Submitted QC: 2019-04-26
• Study First Posted: 2019-05-01
• Study Start: 2019-06-30
• Primary Completion: 2020-11-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-20
• Last Update Posted: 2023-06-22
• Study Completion: 2024-09

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• Status: WITHDRAWN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

Arm && Interventions

Group	Intervention	Description
Control	Restoration of carious lesions	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.
Simplified restorative procedure	Restoration of carious lesions	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

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