Clinical trial NCT04449393: Enamel Matrix Derivative in Non-surgical Periodontal Treatment
Official title: Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Keywords: Enamel Matrix Derivative
Periodontitis
Non-surgical periodontal therapy
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-06-26
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Periodontal probing depth (PPD)
timeFrame: At baseline
measure: Periodontal probing depth (PPD)
timeFrame: After 3 months
measure: Periodontal probing depth (PPD)
timeFrame: After 6 months
measure: Periodontal probing depth (PPD)
timeFrame: After 12 months
Secondary outcomes:
measure: CAL (mm)
timeFrame: At baseline, after 3, 6 and 12 months
measure: API, PBI (%)
timeFrame: At baseline, after 3, 6 and 12 months
measure: PESA, PISA (mm2)
timeFrame: At baseline, after 3, 6 and 12 months
measure: GCF markers for periodontal regeneration
timeFrame: At baseline, after 3, 6 and 12 months
measure: Periodontal bacteria
timeFrame: At baseline, after 3, 6 and 12 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University Clinic of Dentistry Vienna
Study officials:
References: