Osteoplasty in Conjunction With Surgical Treatment of Mandibular Grade III Furcation Defects (FURC-III-OST)

NCT ID: NCT04017429

Last Updated: 2021-04-30

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2027-06-15

Brief Summary

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Teeth with furcation grade III defects will be treated with open flap debridement, with or without osteoplasty. The study is designed to examine the effect of osteoplasty in the treatment of teeth with furcation grade III defects with open flap debridement.

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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Open flap debridement with osteoplasty

In this arm, periodontal surgery consists of open flap debridement followed by osteoplasty in the furcation entrance area.

Group Type EXPERIMENTAL

Open flap debridement with osteoplasty

Intervention Type PROCEDURE

Treatment of furcation grade III defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to \>90 degrees relative to the apico-coronal axis of the tooth.

Open flap debridement without osteoplasty

Intervention Type PROCEDURE

Treatment of furcation grade III defect with open flap debridement only.

Open flap debridement without osteoplasty

In this arm, periodontal surgery consists of open flap debridement only. No osteoplasty will be performed.

Group Type ACTIVE_COMPARATOR

Open flap debridement with osteoplasty

Intervention Type PROCEDURE

Treatment of furcation grade III defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to \>90 degrees relative to the apico-coronal axis of the tooth.

Open flap debridement without osteoplasty

Intervention Type PROCEDURE

Treatment of furcation grade III defect with open flap debridement only.

Interventions

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Open flap debridement with osteoplasty

Treatment of furcation grade III defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to \>90 degrees relative to the apico-coronal axis of the tooth.

Intervention Type PROCEDURE

Open flap debridement without osteoplasty

Treatment of furcation grade III defect with open flap debridement only.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Periodontal disease stage III or IV according to 2018 criteria
* Undergoing periodontal therapy (active or supportive) and present 1 or more pair of bilateral mandibular molars affected by furcation involvement grade III with PPD\>4mm, and the furcation fornix must be above a tangential line from the distal to mesial interproximal crestal bone level on bitewing radiographs
* Competent to give consent

Exclusion Criteria

* 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 II according to ASA classification
* Previous surgical therapy of included furcation defects
* Inhability to comprehend and respond to the quality of life questionnaire
* Dental restorations or prosthesis involving the furcation area
* Root fractures or suspected fractures/infractions
* Caries lesoins 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, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Institute of Clinical Dentistry, University of Oslo, Norway

Oslo, , Norway

Site Status

Countries

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Norway

Other Identifiers

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FURC-III-OST

Identifier Type: -

Identifier Source: org_study_id

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