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Mandibular Furcation II Regeneration

NCT ID: NCT04059445

Last Updated: 2023-11-30

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2023-11-27

Brief Summary

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Teeth with furcation grade II defects will be treated with open flap debridement and regenerative therapy with biphasic calcium phosphate combined with either enamel matrix proteins or a collagen membrane.

Detailed Description

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Conditions

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Furcation Defects Periodontal Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Regenerative therapy w/BCP and collagen membrane

In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and collagen membrane.

Group Type EXPERIMENTAL

Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)

Intervention Type DEVICE

Regenerative therapy with biphasic calcium phosphate + collagen membrane.

Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

Intervention Type DRUG

Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.

Regenerative therapy w/BCP and enamel matrix proteins

In this arm, treatment of furcation grade II defects includes open flap debridement and regenerative therapy with biphasic calcium phosphate (BCP) and enamel matrix proteins.

Group Type ACTIVE_COMPARATOR

Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)

Intervention Type DEVICE

Regenerative therapy with biphasic calcium phosphate + collagen membrane.

Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

Intervention Type DRUG

Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.

Interventions

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Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)

Regenerative therapy with biphasic calcium phosphate + collagen membrane.

Intervention Type DEVICE

Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)

Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject must be ≥ 20 years
* Subject must have periodontal disease as determined by the World Workshop 2017 criteria
* Subjects must be undergoing periodontal treatment or follow-up and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade II with PPD \>4 mm, and the furcation fornix must be below a tangential line from the distal to mesial interproximal crestal bone level
* Competent to give consent

Exclusion Criteria

The following must not be present at the time of enrolment;

* Previous radiotherapy to the jaws, current use of chemotherapy, systemic long-term corticosteroid treatment
* Present or past use of bisphosphonate treatment
* Pregnant or nursing subjects
* Patients classified as \> class 2 according to the ASA (American Society of Anesthesiologists) physical status classification
* Previous surgical therapy of included furcation defects
* Inability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected infractions
* Caries lesions in the furcation area
* No systemic antibiotic treatment within 3 months prior to intervention
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Anders Verket

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Clinical Dentistry, Faculty of Dentistry, University of Oslo

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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FURC-II-REGEN

Identifier Type: -

Identifier Source: org_study_id