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Carious Tissue Selective Removal on Permanent Posterior Teeth.

NCT ID: NCT04533113

Last Updated: 2020-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

111 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-20

Study Completion Date

2026-07-31

Brief Summary

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This study is a prospective randomized controlled study of patients who come to the University. The aim is to evaluate the success rate of selective removal of carious tissue in deep lesions of posterior teeth. Three different materials will be used as liners (VitreBond ™Plus, BioDentine™, and Theracal™ LC). Post-operative pain, clinical, and radiographic success will be evaluated at one, two, and five-year follow-up. The null hypothesis is that there will be no statistically significant differences in rates of successful treatment with the three materials used.

Detailed Description

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Conditions

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Dental Caries Dental Materials

Keywords

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Dental caries Dental materials Outcome Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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VitreBond LC

VitreBond LC used as a liner after selective carious tissue removal.

Group Type EXPERIMENTAL

Carious tissue selective removal

Intervention Type PROCEDURE

Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration

Biodentine

Biodentine used as a liner after selective carious tissue removal.

Group Type EXPERIMENTAL

Carious tissue selective removal

Intervention Type PROCEDURE

Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration

Theracal

Theracal used as a liner after selective carious tissue removal.

Group Type EXPERIMENTAL

Carious tissue selective removal

Intervention Type PROCEDURE

Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration

Interventions

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Carious tissue selective removal

Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients that demonstrate understanding of the study and willingness to participate as evidenced by signing the voluntary informed consent and received a signed and dated copy of the informed consent form.
* Understands and is willing to comply with all study procedures and restrictions.
* Not presence of clinically significant and relevant abnormalities of clinical history or oral examination.
* Diagnosis of normal pulp or reversible pulpitis.
* No presence of periapical periodontitis
* Posterior teeth

Exclusion Criteria

General: Patients with systemic diseases, diabetes, immunocompromised and pregnant women, or any clinically significant or relevant oral abnormalities.

Specific: Impossibility of restoration, diagnosis of irreversible pulpitis or necrosis, preoperative pain
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Juan Gonzalo Olivieri

OTHER

Sponsor Role lead

Responsible Party

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Juan Gonzalo Olivieri

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Universitat Internacional de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Site Status RECRUITING

Countries

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Spain

Facility Contacts

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Juan G. Olivieri, DDS, PhD

Role: primary

Other Identifiers

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ENDECL201804

Identifier Type: -

Identifier Source: org_study_id