NCT04449393

Enamel Matrix Derivative in Non-surgical Periodontal Treatment

Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 25 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to investigate the effect of enamel matrix derivative in addition to scaling and root planing in comparison to scaling and root planing only in periodontitis patients that have already undergone initial periodontal therapy and are in periodontal maintenance.

Detailed description

Enamel matrix derivative (EMD) have already been widely applied as a regenerative bio-modulator in periodontal surgery and have been demonstrated to enhance periodontal regeneration. Recently, also its flapless, non-surgical application has been shown to have beneficial effects when applied during initial therapy of periodontitis. The present study is designed as a single-blinded randomized controlled clinical trial. We plan to include a total of 50 periodontitis patients that have already undergone initial periodontal therapy, but still show remaining sites with increased periodontal probing depth (PPD). Patients will be randomly allocated at a 1:1 ratio to either scaling and root planing (SRP) in combination with EMD application into the affected pockets (test group, n=25) or to SRP only (control group, n=25). Before treatment, as well as after 3, 6 and 12 months, we plan to assess site-specific periodontal parameters as well as whole-mouth oral hygiene indices. Furthermore, we intend to evaluate gingival crevicular fluid, as well as parameters representing periodontal disease activity.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DEVICE	Emdogain® FL	Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.
OTHER	Scaling and root planing	Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.

Timeline

• Start date: 2020-09-15
• Primary completion: 2022-05-01
• Completion: 2022-07-01
• First posted: 2020-06-26
• Last updated: 2022-10-25

Locations

1 site across 1 country: Austria