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| Name | Class |
|---|---|
| University of Turku | OTHER |
| University of Oslo | OTHER |
| Labrida AS | INDUSTRY |
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Patients diagnosed with stage III or IV periodontitis who exhibit mandibular first or second molars with Class II, Subclass A, or B buccal and/or lingual mandibular furcation defects (horizontal probing depth of ≥ 3 mm ) will be recruited.
Patients diagnosed with stage III or IV periodontitis who exhibit maxillary first or second molars with Class II, Subclass A, or B buccal furcation defects (horizontal probing depth of ≥ 3 mm ) if furcation involvement on the palatal side (mesiopalatal and distopalatal) does not exceed Class 1 will be recruited.
This study will be a prospective, randomized, single-blinded, controlled clinical trial with a split-mouth design.
Patients will be recruited from the clinics of the Riga Stradiņš University Institute of Stomatology of Riga, Latvia.
Before the baseline treatment, all patients who meet the inclusion criteria will be given detailed oral hygiene instructions and motivation.
Patients' furcation defects in each quadrant will be randomly allocated at a 1:1 ratio to either the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives (test group) or Oscillating Chitosan Brush alone (control group).
Non-surgical periodontal treatment of furcation defects on the test side will be performed through the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives and on the control side with Oscillating Chitosan Brush alone.
The re-evaluation of periodontal status will be performed 12 weeks following the baseline treatment.
Biofilm samples and gingival crevicular fluid (GCF) samples will be taken at the baseline and at 4 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chitosan brush with Emdogain FL | Experimental | Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® and Straumann® Emdogain® FL at Baseline |
|
| Chitosan brush alone | Sham Comparator | Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® at Baseline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emdogain® FL | Device | Enamel Matrix Derivatives |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Bleeding on Probing index (mBoP) | Pseudo marker of inflammation, lower scores mean a better outcome 0 = no bleeding;
| Baseline, 12 weeks |
| Probing Pocket Depth (PPD) in mm | Pseudo marker of inflammation, lower scores mean a better outcome. | Baseline,12 weeks |
| Clinical Attachment Level (CAL) in mm | Marker of gain in attachment, lower scores mean a better outcome | Baseline, 12 weeks |
| Furcation Involvement 1 | Marker of gain in attachment, Horizontal Furcation involvement measurement using Nabers Probe
| Baseline, 12 weeks |
| Furcation Involvement 2 in mm | Marker of gain in attachment, Horizontal Furcation involvement measurement using UNC 15mm probe, lower scores mean a better outcome | Baseline, 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proteomic profile of gingival crevicular fluid (GCF) | Differences in the GCF of regeneration-related marker concentrations between test and control groups | Baseline, 4 weeks, |
| Microbiological changes in microbial plaque |
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Inclusion criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anete Vaškevica, DDS | Contact | +37120202028 | anete.vaskevica@rsu.lv | |
| Dārta E Emuliņa, DDS | Contact | +37122007988 | dartaemulina@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ilze Akota, PhD | Riga Stradins University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riga Stradins University Institute of Stomatology | Recruiting | Riga | Latvia |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| D017823 | Furcation Defects |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Randomised, single-blinded, split-mouth clinical trial
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| Labrida BioClean® |
| Device |
Oscillating Chitosan Brush |
|
Differences in the microbial profile between test and control groups
| Baseline, 4 weeks, |
| Visual analog scale (VAS) | Evaluation of self-perceived pain using a 100 mm Visual analog scale (range 0 - 100) at baseline treatment visit; 0 - no pain, 100 - worst pain ever felt. Lower scores mean a better outcome. | Baseline |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |