Enamel Matrix Derivative in Non-surgical Periodontal Treatment

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Device: Emdogain® FL; Other: Scaling and root planing

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 Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • University Clinic of Dentistry Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Placebo Comparator: Control group; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	At baseline
Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	After 3 months
Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	After 6 months
Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	After 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CAL (mm)	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	At baseline, after 3, 6 and 12 months
API, PBI (%)	API: Approximal plaque index PBI: Papillary Bleeding Index	At baseline, after 3, 6 and 12 months
PESA, PISA (mm2)	PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area	At baseline, after 3, 6 and 12 months
GCF markers for periodontal regeneration	GCF: Gingival crevicular fluid	At baseline, after 3, 6 and 12 months
Periodontal bacteria	Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit	At baseline, after 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2020
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 25, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Periodontitis; Non-surgical periodontal therapy; Enamel Matrix Derivative
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: 1248/2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No