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Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients

NCT ID: NCT02972788

Last Updated: 2023-12-01

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

EARLY_PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-09-20

Brief Summary

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The purpose of the study is to determine the effect of enamel matrix protein derivative on an inflamed, periodontal-involved tooth. The hypothesis to be studied is that enamel matrix derivative protein with increase the clinical attachment level is localized sites of advanced periodontal disease.

Detailed Description

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The purpose of this study is to determine if local application of a commercially-available, FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing clinical attachment levels (primary outcome), as well as alveolar bone (secondary outcome) compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). Subjects will be divided into two groups for additional therapy in a 6-9 mm interproximal periodontal pocket at baseline: 1) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of the enamel matrix protein derivate or 2) local anesthesia and mini-flap reflection with subgingival mechanical debridement plus application of saline. Samples/measurements will be obtained at the designated experimental site at baseline, 2 weeks, 6 and 12 months during PMT: 1) digital radiograph (baseline and 12 months only; bone height measurements), 2) presence of explorer-detectable supragingival plaque, 3) 30-second gingival crevicular fluid (GCF) sample (markers of inflammation, bone turnover), 4) recession from the cemento-enamel junction, 5) probing pocket depth and bleeding on probing (BOP). Following the 12-month visit, the research-specific interventions and measurements in the experimental quadrant will be removed from routine PMT.

Conditions

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Periodontal Bone Loss

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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Experimental Group

Group will receive enamel matrix protein derivative treatment along with scaling and root planing.

Group Type EXPERIMENTAL

Enamel Matrix Proteins Derivative

Intervention Type DRUG

Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Control Group

Group will receive placebo (saline) treatment along with scaling and root planing.

Group Type SHAM_COMPARATOR

Saline

Intervention Type OTHER

Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Interventions

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Enamel Matrix Proteins Derivative

Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Intervention Type DRUG

Saline

Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Intervention Type OTHER

Other Intervention Names

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Emdogain

Eligibility Criteria

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Inclusion Criteria

* diagnosis of chronic advanced adult periodontitis
* one quadrant with at least one 6-9 mm interproximal pocket
* overall good systemic health
* willingness to sign consent form

Exclusion Criteria

* systemic diseases which significantly impact periodontal inflammation and bone turnover (e.g. rheumatoid arthritis)
* taking drugs which significantly impact periodontal inflammation and bone turnover
* surgical periodontal therapy within the past year
* pregnant or breast-feeding females
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Nebraska

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy Killeen, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Other Identifiers

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0783-16-FB

Identifier Type: -

Identifier Source: org_study_id