Enamel Matrix Derivative in Non-surgical Periodontal Treatment

  • STATUS
    Recruiting
  • End date
    Jan 23, 2023
  • participants needed
    50
  • sponsor
    Medical University of Vienna
Updated on 23 April 2022
periodontal disease
root planing
periodontal treatment
periodontal maintenance
dental plaque

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.

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.

Details
Condition Periodontitis
Treatment Scaling and root planing, Emdogain® FL
Clinical Study IdentifierNCT04449393
SponsorMedical University of Vienna
Last Modified on23 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Periodontitis stage III
Patients that have completed initial periodontal therapy, and have remaining periodontal pockets of ≥6mm up to 9mm PPD
Given written informed consent form for participation in the study

Exclusion Criteria

Systemic antibiotics within the previous 3 months
Pregnant or breastfeeding women
Any current or past clinically significant pathology/disease (comorbidity) that, in the opinion of the periodontists, might confound the results or poses an additional risk to the subject during participation in the study, such as renal insufficiency, malignancy, rheumatoid osteoarthritis, human immunodeficiency syndrome
Patients with at least one tooth of mobility grade 0 or 1 and/or furcation involvement grade 0 or I according to Hamp
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