Bone Regenerative Techniques in Endodontic Microsurgery

NCT ID: NCT04514991

Last Updated: 2022-11-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-03

Study Completion Date

2022-03-30

Brief Summary

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The purpose of this randomized controlled clinical trial was to evaluate two dimensionally and 3-dimensionally the effect of resorbable collagen-based bone filling material on periapical healing following endodontic microsurgery (EMS) on endodontic lesions presenting four-wall defect.

Detailed Description

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Conditions

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Apical Periodontitis

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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Treatment

Surgical sites (osteotomy) assigned to this group received endodontic microsurgery procedure+ Foundation (J. Morita USA).

Group Type EXPERIMENTAL

Foundation

Intervention Type DEVICE

Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.

Control

Surgical sites (osteotomy) assigned to this group receives endodontic microsurgery procedure only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Foundation

Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy adult.
* Intact coronal restoration with no sign of leakage.
* Class B (small lesion) and C (large lesion) periapical lesions. (Kim and Kratchman 2006)

Exclusion Criteria

* Patients with medical conditions and contraindications to surgery.
* Minors.
* Pregnancy.
* Teeth with signs of coronal leakage.
* Teeth with vertical root fractures.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bekir Karabucak, DMD, MS

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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UPenn

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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833538

Identifier Type: -

Identifier Source: org_study_id

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