Periodontitis, AdultNCT06684769
A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
A study testing Emdogain® FL and Labrida BioClean® in people with Periodontitis, Adult and Furcation Defects, run by Riga Stradins University at 1 site in Latvia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Adult, Furcation Defects, Furcation of Root of Tooth
- What is being tested?
- Emdogain® FL and Labrida BioClean®
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteLatvia
- Study dates
- 15 Nov 2024to Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient is 18 years of age or older
- The patient does not have any systemic diseases that may affect the results of the study
- The patient has a plaque index of 20% or less at the study entry
- The patient has a history of severe localized or generalized periodontitis (stage III or IV)
- Completed the first and second steps of periodontal treatment (According to Treatment of stage I-III periodontitis-The EFP S3 level clinical practice guideline) (Sanz M. et al.)
- Buccal and/or lingual Class 2A and/or 2B furcation involvement (FI) defects on both sides of the Mandibular first and/or second molars after completing the first and second steps of periodontal treatment.
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- Buccal Class 2A and/or 2B furcation involvement (FI) defects on both sides of the maxillary first and/or second molars after completion of the first and second step of periodontal treatment if furcation involvement on the palatal side (mesiopalatal and distopalatal) does not exceed Class 1.
- Psychological appropriateness
- Consents to all follow-up visits
Who cannot join
- Patients who have systemic diseases that may affect the results of the study
- Use of medications that may affect study results (anti-osteoporotic drugs, statins, corticosteroids, anticoagulants)
- Patients who use calcium channel blockers, cyclosporine A or antiepileptic drugs if there are clinically visible hyperplastic changes in the gingival margin.
- Patients who have received any type of systemic antibiotics in the last six months prior to the start of the study and patients starting antibiotics during the study
- Patients requiring antibiotic premedication prior to periodontal treatment
- Oncological disease
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- Chemotherapy and/or radiotherapy (active or history)
- Pregnancy and breastfeeding
- Any condition or current treatment which, in the opinion of the investigator and/or consulting physician, may present an unreasonable risk
- Psychoemotional disorders and depression
- Use of antipsychotic medication or antidepressants
- Lack of patient motivation to undertake adequate dental care at home or complete periodontal treatment, patients residing outside Latvia
- Molars with combined endodontic-periodontal lesions, active endodontic infection
- Prosthetic factors for molars not allowing clinical measurements
- Huge restoration or amalgam fillings that could potentially cause fractures or furcation involvement
- Enamel pearls or filling or crown margins
- Decay or root resorption
- Tooth mobility degree 3
- Molars in which the gingival margin is positioned apically from the entrance into the furcation area
- Clinical attachment level and or pockets mesial and distal to the furcation involvement defect of 6 or more mm
- Strong vomiting reflex that would prevent adequate periodontal treatment
- People close to the study subjects, work colleagues, relatives, etc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Latvia1 site, 1 recruiting
- Recruiting
Riga Stradins University Institute of Stomatology
Riga
Anete Vaskevica, DDS, +37120202028, anete.vaskevica@rsu.lv
Darta E Emulina, DDS, +37122007988, dartaemulina@gmail.com
About this study
Official title: Non-surgical Treatment of Mandibular and Maxillary Molar Furcations With a Chitosan Brush With Adjunct Enamel Matrix Derivative- a Split-mouth Randomized Clinical Trial
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.
Read more
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.
- Conditions
- Periodontitis, Adult, Furcation Defects, Furcation of Root of Tooth, Periodontitis Complex
- Being tested
- Emdogain® FL, Labrida BioClean®
- Medical subject headings
- Chronic Periodontitis, Furcation Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emdogain® FLDevice
Enamel Matrix Derivatives
Labrida BioClean®Device
Oscillating Chitosan Brush
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Emdogain® FL; Device: Labrida BioClean® |
| Chitosan brush alone | Sham comparator | Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® at Baseline Receives: Device: Labrida BioClean® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Bleeding on Probing index (mBoP)
Pseudo marker of inflammation, lower scores mean a better outcome 0 = no bleeding;
- = a bleeding spot;
- = a bleeding line;
- = pronounced bleeding within 30 seconds following probing of the pocket
Measured: Baseline, 12 weeks
Probing Pocket Depth (PPD) in mm
Pseudo marker of inflammation, lower scores mean a better outcome.
Measured: Baseline,12 weeks
Clinical Attachment Level (CAL) in mm
Marker of gain in attachment, lower scores mean a better outcome
Measured: Baseline, 12 weeks
Furcation Involvement 1
Marker of gain in attachment, Horizontal Furcation involvement measurement using Nabers Probe
- Horizontal loss of periodontal tissue support less than 3 mm
- Horizontal loss of support 3 mm or more, but not encompassing the total width of the furcation
- Horizontal through-and-through destruction of the periodontal tissue in the furcation Lower scores mean a better outcome
Measured: 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
Measured: Baseline, 12 weeks
Secondary outcomes (3)
Proteomic profile of gingival crevicular fluid (GCF)
Differences in the GCF of regeneration-related marker concentrations between test and control groups
Measured: Baseline, 4 weeks,
Microbiological changes in microbial plaque
Differences in the microbial profile between test and control groups
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start15 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, single-blinded, split-mouth clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riga Stradins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, University of Oslo, Labrida AS
- Responsible party
- Principal investigator, Anete Vaškevica, Riga Stradins University
- Investigators
- Ilze Akota, PhD, Study chair, Riga Stradins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684769
- Sponsor's protocol ID
- 2-PĒK-4/659/2024
- Status last verified
- Feb 2025
- First submitted
- 5 Nov 2024
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No