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

NCT02972788 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 0783-16-FB
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Periodontal Bone Loss

Outcome Measures

Primary Outcomes (1)

• Clinical Attachment Levels

  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 (periodontal tissue support) compared to standard mechanical therapy in patients on periodontal maintenance therapy (PMT). The following will be used in combination to evaluate impacts: digital radiograph (bone height), explorer-detectable supragingival plaque, 30-second GCF sample (markers of inflammation and bone turnover), recession, probing pocket depth (measurement of clinical attachment loss), and bleeding on probing (BoP).

  12 months

Secondary Outcomes (1)

• Alveolar bone

  12 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Drug: Enamel Matrix Proteins Derivative

Control Group

SHAM COMPARATOR

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

Other: Saline

Interventions

Enamel Matrix Proteins Derivative DRUG

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

Also known as: Emdogain

Experimental Group

Saline OTHER

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

Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska Medical Center, College of Dentistry

Lincoln, Nebraska, 68503, United States

Location

MeSH Terms

Conditions

Alveolar Bone Loss

Interventions

enamel matrix proteins; Sodium Chloride

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Amy Killeen, DDS, MS

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: November 23, 2016
• Study Start: February 1, 2017
• Primary Completion: September 20, 2018
• Study Completion: September 20, 2018
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)