Enamel Matrix Derivative in Non-surgical Periodontal Treatment
Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients
1 other identifier
interventional
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 26, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedOctober 25, 2022
October 1, 2022
1.6 years
June 20, 2020
October 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 Outcomes (5)
CAL (mm)
At baseline, after 3, 6 and 12 months
API, PBI (%)
At baseline, after 3, 6 and 12 months
PESA, PISA (mm2)
At baseline, after 3, 6 and 12 months
GCF markers for periodontal regeneration
At baseline, after 3, 6 and 12 months
Periodontal bacteria
At baseline, after 3, 6 and 12 months
Study Arms (2)
Emdogain® FL
EXPERIMENTALNon-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.
Control group
PLACEBO COMPARATORNon-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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Clinic of Dentistry Vienna
Vienna, 1090, Austria
Related Publications (1)
Wehner C, Tur D, Durstberger G, Laky M, Laky B, Andrukhov O, Moritz A, Rausch-Fan X. Effects of enamel matrix derivative in nonsurgical periodontal therapy on pro-inflammatory profiles, microbial environment and clinical outcome: a randomized clinical trial. Clin Oral Investig. 2023 Nov;27(11):6493-6502. doi: 10.1007/s00784-023-05254-1. Epub 2023 Oct 16.
PMID: 37843637DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.med.dent.
Study Record Dates
First Submitted
June 20, 2020
First Posted
June 26, 2020
Study Start
September 15, 2020
Primary Completion
May 1, 2022
Study Completion
July 1, 2022
Last Updated
October 25, 2022
Record last verified: 2022-10