Enamel Matrix Derivative in Non-surgical Periodontal Treatment

Not Applicable

Completed

• Conditions: Periodontitis
• Interventions: Other: Scaling and root planing; Device: Emdogain® FL

• Registration Number: NCT04449393
• Lead Sponsor: Medical University of Vienna

Brief 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.

Study Timeline

• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-25
• Study First Posted: 2020-06-26
• Study Start: 2020-09-15
• Primary Completion: 2022-05-01
• Study Completion: 2022-07-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-22
• Last Update Posted: 2022-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Scaling and root planing	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.
Emdogain® FL	Emdogain® FL	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.

Primary Outcome Measures

Name	Time	Method
Periodontal probing depth (PPD)	After 12 months	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe

Secondary Outcome Measures

Name	Time	Method
CAL (mm)	At baseline, after 3, 6 and 12 months	CAL (Clinical attachment level): the probing depth and the distance from the gingival margin to the CEJ API: Approximal plaque index PBI: Papillary Bleeding Index PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area GCF: Gingival crevicular fluid
Periodontal bacteria	At baseline, after 3, 6 and 12 months	Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit
PESA, PISA (mm2)	At baseline, after 3, 6 and 12 months	PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area
API, PBI (%)	At baseline, after 3, 6 and 12 months	API: Approximal plaque index PBI: Papillary Bleeding Index
GCF markers for periodontal regeneration	At baseline, after 3, 6 and 12 months	GCF: Gingival crevicular fluid

Trial Locations

Locations (1)

University Clinic of Dentistry Vienna; 🇦🇹 Vienna, Austria