Enamel Matrix Derivative in Non-surgical Periodontal Treatment

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04449393
• Other study ID #: 1248/2020
• Status: Completed
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: October 2022
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.

Locations

Country	Name	City	State
Austria	University Clinic of Dentistry Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	At baseline
Primary	Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	After 3 months
Primary	Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	After 6 months
Primary	Periodontal probing depth (PPD)	Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe	After 12 months
Secondary	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
Secondary	API, PBI (%)	API: Approximal plaque index PBI: Papillary Bleeding Index	At baseline, after 3, 6 and 12 months
Secondary	PESA, PISA (mm2)	PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area	At baseline, after 3, 6 and 12 months
Secondary	GCF markers for periodontal regeneration	GCF: Gingival crevicular fluid	At baseline, after 3, 6 and 12 months
Secondary	Periodontal bacteria	Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit	At baseline, after 3, 6 and 12 months