NCT02972788

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: University of Nebraska · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontal Bone Loss

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-09-20
• Completion: 2018-09-20
• First posted: 2016-11-23
• Last updated: 2023-12-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study