University Clinic of Dentistry Vienna
Vienna, 1090, Austria
NCT Number: NCT04449393
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.
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Notify Me25 year–75 year
All sexes
Interventional
Not applicable
Vienna, 1090, Austria
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: At baseline
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Time frame: After 3 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Time frame: After 6 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Time frame: After 12 months
Distance from the gingival margin to the base of the pocket with a calibrated periodontal probe
Time frame: 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
Time frame: At baseline, after 3, 6 and 12 months
API: Approximal plaque index PBI: Papillary Bleeding Index
Time frame: At baseline, after 3, 6 and 12 months
PESA:Periodontal Epithelial Surface Area PISA: periodontal inflamed surface area
Time frame: At baseline, after 3, 6 and 12 months
GCF: Gingival crevicular fluid
Time frame: At baseline, after 3, 6 and 12 months
Microbiologic evaluation of GCF via polymerase chain reaction (PCR) DNA probe test kit
Medical University of Vienna
Other
Effect of Enamel Matrix Derivative in the Non-surgical Treatment of Periodontal Maintenance Patients
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