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Currently, you can access the following clinical trials being conducted worldwide:

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Absence of Liner Following the Selective Caries Removal (ALFSCaRe)

Clinicaltrials.gov identifier NCT03933176

Recruitment Status Recruiting

First Posted May 1, 2019

Last update posted November 12, 2020

Study Description

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.

  • Condition or Disease:Caries; Dentin
    Dental Restoration Failure of Marginal Integrity
  • Intervention/Treatment: Procedure: Restoration of carious lesions
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 340 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Is the Use of a Glass Ionomer Liner Necessary After Selective Carious Tissue Removal?
  • Actual Study Start Date: June 2019
  • Estimated Primary Completion Date: November 2020
  • Actual Study Completion Date: September 2024
Arms and interventions
Arm Intervention/treatment
Active Comparator: Control
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.
Procedure: Restoration of carious lesions
Selective carious tissue removal followed by restoration of the cavity using composite resin.
Experimental: Simplified restorative procedure
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).
Procedure: Restoration of carious lesions
Selective carious tissue removal followed by restoration of the cavity using composite resin.
Outcome Measures
  • Primary Outcome Measures: 1. Longevity of restoration [ Time Frame: Annual evaluation during 5 years ]
    Assessment of any failure in restorations according to the FDI World Dental Federation criteria.
  • Secondary Outcome Measures: 1. Tooth sensitivity [ Time Frame: 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.
Eligibility Criteria
  • Ages Eligible for Study: 6 to 40 Years (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
Criteria

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.

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Universidade Federal de Sergipe

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Federal University of Pelotas

University of Brasilia

Universidade Federal do Ceara

Federal University of Uberlandia

Universidade Veiga de Almeida

More Information
  • Responsible Party: Universidade Federal de Sergipe
  • ClinicalTrials.gov Identifier: NCT03933176 History of Changes
  • Other Study ID Numbers: UFS/Prodonto
  • First Posted: May 1, 2019 Key Record Dates
  • Last Update Posted: November 12, 2020
  • Last Verified: November 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Product Manufactured in and Exported from the U.S.: Yes
  • Keywords provided by Universidade Federal de Sergipe: Glass ionomer Bulk-Fill Composite