Enamel Matrix Derivative in Non-surgical Periodontal Treatment

Medical University of Vienna

Status: Completed

Conditions: Periodontitis

Treatments: Device: Emdogain® FL; Other: Scaling and root planing

Study type: Interventional

Funder types: Other

Identifiers

NCT04449393

1248/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 25 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 2 patient groups, including a placebo group

Emdogain® FL

Experimental group

Description:

Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation. EDTA gel will be applied for 2 minutes in the respective pockets, followed by rinsing with saline, drying and application of Emdogain® FL.

Treatment:

Device: Emdogain® FL

Control group

Placebo Comparator group

Description:

Non-surgical periodontal therapy in terms of scaling and root planing will be applied at sites with remaining periodontal pockets at reevaluation, followed by rinsing with saline.

Treatment:

Other: Scaling and root planing