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Prospective Clinical Trial of Three Apical Sealing Materials

NCT ID: NCT04198298

Last Updated: 2019-12-13

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

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-02

Study Completion Date

2017-05-31

Brief Summary

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This prospective comparative randomized clinical trial compares healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

Detailed Description

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A prospective comparative randomized clinical trial was designed to evaluate the healing and bony regeneration in patients who received 1 of 3 different retrograde filling materials (EndoSequence®, ProRoot® MTA, or Biodentine®) following microsurgical apicoectomies for the treatment of periapical lesions of endodontic origin.

Conditions

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Periapical Abscess

Keywords

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Cone-Beam Computed Tomography Microsurgery Bone Regeneration Biocompatible Materials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group 1 EndoSequence

The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.

Group Type ACTIVE_COMPARATOR

EndoSequence

Intervention Type DRUG

The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.

Group 2 ProRoot MTA

The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.

Group Type ACTIVE_COMPARATOR

ProRoot MTA

Intervention Type DRUG

The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.

Group 3 Biodentine

The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.

Group Type ACTIVE_COMPARATOR

Biodentine

Intervention Type DRUG

The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.

Interventions

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EndoSequence

The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.

Intervention Type DRUG

ProRoot MTA

The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.

Intervention Type DRUG

Biodentine

The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.

Intervention Type DRUG

Other Intervention Names

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EndoSequence® ProRoot® MTA Biodentine®

Eligibility Criteria

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Inclusion Criteria

* Adult patients, American Society of Anesthesiologists (ASA) classification I and II
* Any tooth with a single chronic periapical lesion requiring apical microsurgery
* Informed consent signed prior to surgery

Exclusion Criteria

* Background of drug/alcohol abuse
* Adjacent periapical lesion
* Periodontal disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of the Pacific

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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20-60

Identifier Type: -

Identifier Source: org_study_id