Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02972788
Other study ID # 0783-16-FB
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date February 1, 2017
Est. completion date September 20, 2018

Study information

Verified date November 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 20, 2018
Est. primary completion date September 20, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Enamel Matrix Proteins Derivative
Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
Other:
Saline
Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.

Locations

Country Name City State
United States University of Nebraska Medical Center, College of Dentistry Lincoln Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Alveolar bone This study is to determine if local application of a commercially-available, FDA-approved preparation of enamel-matrix protein derivatives is effective in increasing alveolar bone 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
See also
  Status Clinical Trial Phase
Recruiting NCT03997578 - Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects N/A
Completed NCT02374216 - A Prospective Analysis of Failures of Oral Implants N/A
Completed NCT02369562 - A Retrospective Analysis of Failures of Oral Implants
Completed NCT02218515 - Treatment of Intrabony Periodontal Defects With Enamel Matrix Derivatives and Autogenous Bone Graft Phase 4
Completed NCT05631600 - Manuka Honey as an Adjunct to Non-surgical Periodontal Therapy: Clinical Study Phase 2/Phase 3
Completed NCT03715374 - Platelet-Rich Fibrin and Anorganic Bovine Bone vs Collagen Membrane and Anorganic Bovine Bone in Intrabony Defects N/A
Completed NCT04160689 - Influence of the Implant Connection on Facial Tissues Maturation Phase 4
Recruiting NCT05533528 - Periodontal Granulation Tissue Preservation in Surgical Periodontitis Treatment N/A
Completed NCT02416700 - Evaluation of Peri Implant Bone Loss of Immediately Versus Conventionally Loaded Implants With a Single Prosthesis N/A
Completed NCT03227367 - Osteoclast Impairment in Chronic Periodontitis by Regenerative Materials. N/A
Not yet recruiting NCT04274244 - Comparison of Clinical and Radiographic Parameters in the Application of Cross-linked Hyaluronic Acid 1.8% and Enamel Matrix Derivative in Periodontal Regeneration. Phase 4
Recruiting NCT05766878 - The Rehabilitation of Atrophic Jaws Using Short Implants With Different Surface Characteristics N/A
Recruiting NCT03978962 - Performance and Safety of the Resorbable Collagen Membrane "Ez Cure"
Completed NCT04043754 - Platelet-rich Fibrin and Autogenous Bone vs Membrane and Autogenous Bone in Intrabony Defects N/A
Recruiting NCT06318247 - Using Xenograft Combined With Barrier Membrane to Improve the Formation of Deep Periodontal Pockets N/A
Active, not recruiting NCT00519155 - Pilot Study on MD05 in Comparison With Open Flap Debridement in Patients Undergoing Periodontal Surgery Phase 2
Active, not recruiting NCT03510780 - Platelet-rich Fibrin and Autogenous Bone vs Enamel Matrix Derivative and Autogenous Bone in Intrabony Defects N/A
Enrolling by invitation NCT05932017 - Comparison of Gingival Flap Procedure Using Conventional Surgical Loupes vs. Videoscope for Visualization
Completed NCT05360511 - Erythropoietin Gel as an Adjunct to Xenograft in the Surgical Management of Intrabony Periodontal Defects Early Phase 1
Completed NCT04827693 - The Cortical Shield for Facial Bone Reconstruction