Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Primary Purpose
Periodontal Bone Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Enamel Matrix Proteins Derivative
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Bone Loss
Eligibility Criteria
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
Sites / Locations
- University of Nebraska Medical Center College of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Group will receive enamel matrix protein derivative treatment along with scaling and root planing.
Group will receive placebo (saline) treatment along with scaling and root planing.
Outcomes
Primary Outcome Measures
Effect of Enamel Matrix Proteins on Clinical Attachment Level
Secondary Outcome Measures
Full Information
NCT ID
NCT02972788
First Posted
November 17, 2016
Last Updated
November 12, 2018
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT02972788
Brief Title
Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Official Title
Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
September 20, 2018 (Actual)
Study Completion Date
September 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Group will receive enamel matrix protein derivative treatment along with scaling and root planing.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Group will receive placebo (saline) treatment along with scaling and root planing.
Intervention Type
Drug
Intervention Name(s)
Enamel Matrix Proteins Derivative
Other Intervention Name(s)
Emdogain
Intervention Description
Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
Intervention Type
Other
Intervention Name(s)
Saline
Intervention Description
Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
Primary Outcome Measure Information:
Title
Effect of Enamel Matrix Proteins on Clinical Attachment Level
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Killeen, DDS, MS
Organizational Affiliation
University of Nebraska Medical Center College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska Medical Center College of Dentistry
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68503
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Enamel Matrix Proteins on Clinical Attachment Level and Alveolar Bone in Periodontal Maintenance Patients
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