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RecruitingNCT06684769Updated Sep 8, 2025

A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations

An interventional study of Emdogain® FL and Labrida BioClean® in Periodontitis, Adult, Furcation Defects and Furcation of Root of Tooth, sponsored by Riga Stradins University. Recruiting at 1 site in Latvia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-08.

Sponsored by Riga Stradins University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Aug 2026, 3 months ago, but the record still lists the study as recruiting.
  • Started Nov 2024; still recruiting 1 year 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Periodontitis, Adult
  • Furcation Defects
  • Furcation of Root of Tooth
  • Periodontitis Complex
03

In context

Chronic Periodontitis

377 studies on the registry are indexed under Chronic Periodontitis; 21 are open to participants now.

This study's planned enrollment of 40 is below the median of 46 across 307 interventional studies indexed under Chronic Periodontitis.

Browse Chronic Periodontitis studies →

Lead sponsor

Riga Stradins University is the lead sponsor of 19 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The patient is 18 years of age or older
  2. The patient does not have any systemic diseases that may affect the results of the study
  3. The patient has a plaque index of 20% or less at the study entry
  4. The patient has a history of severe localized or generalized periodontitis (stage III or IV)
  5. 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.)
  6. 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.
  7. 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.
  8. Psychological appropriateness
  9. Consents to all follow-up visits

Exclusion criteria

Exclusion Criteria:

  1. Patients who have systemic diseases that may affect the results of the study
  2. Use of medications that may affect study results (anti-osteoporotic drugs, statins, , anticoagulants)
  3. Patients who use calcium channel blockers, cyclosporine A or antiepileptic drugs if there are clinically visible hyperplastic changes in the gingival margin.
  4. 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
  5. Patients requiring antibiotic premedication prior to periodontal treatment
  6. Oncological disease
  7. Chemotherapy and/or radiotherapy (active or history)
  8. Pregnancy and breastfeeding
  9. Any condition or current treatment which, in the opinion of the investigator and/or consulting physician, may present an unreasonable risk
  10. Psychoemotional disorders and depression
  11. Use of antipsychotic medication or antidepressants
  12. Lack of patient motivation to undertake adequate dental care at home or complete periodontal treatment, patients residing outside Latvia
  13. Molars with combined endodontic-periodontal lesions, active endodontic infection
  14. Prosthetic factors for molars not allowing clinical measurements
  15. Huge restoration or amalgam fillings that could potentially cause fractures or furcation involvement
  16. Enamel pearls or filling or crown margins
  17. Decay or root resorption
  18. Tooth mobility degree 3
  19. Molars in which the gingival margin is positioned apically from the entrance into the furcation area
  20. Clinical attachment level and or pockets mesial and distal to the furcation involvement defect of 6 or more mm
  21. Strong vomiting reflex that would prevent adequate periodontal treatment
  22. People close to the study subjects, work colleagues, relatives, etc.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Chitosan brush with Emdogain FL

    Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® and Straumann® Emdogain® FL at Baseline

    Device: Emdogain® FL · Device: Labrida BioClean®

  • Sham comparator
    Chitosan brush alone

    Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® at Baseline

    Device: Labrida BioClean®

Interventions

  • DeviceEmdogain® FL

    Enamel Matrix Derivatives

  • DeviceLabrida BioClean®

    Oscillating Chitosan Brush

06

What researchers measure

Primary outcomes

  1. Modified Bleeding on Probing index (mBoP)

    Pseudo marker of inflammation, lower scores mean a better outcome 0 = no bleeding; 1. = a bleeding spot; 2. = a bleeding line; 3. = pronounced bleeding within 30 seconds following probing of the pocket

    Time frame: Baseline, 12 weeks

  2. Probing Pocket Depth (PPD) in mm

    Pseudo marker of inflammation, lower scores mean a better outcome.

    Time frame: Baseline,12 weeks

  3. Clinical Attachment Level (CAL) in mm

    Marker of gain in attachment, lower scores mean a better outcome

    Time frame: Baseline, 12 weeks

  4. Furcation Involvement 1

    Marker of gain in attachment, Horizontal Furcation involvement measurement using Nabers Probe 1. Horizontal loss of periodontal tissue support less than 3 mm 2. Horizontal loss of support 3 mm or more, but not encompassing the total width of the furcation 3. Horizontal through-and-through destruction of the periodontal tissue in the furcation Lower scores mean a better outcome

    Time frame: Baseline, 12 weeks

  5. Furcation Involvement 2 in mm

    Marker of gain in attachment, Horizontal Furcation involvement measurement using UNC 15mm probe, lower scores mean a better outcome

    Time frame: Baseline, 12 weeks

Secondary outcomes

  1. Proteomic profile of gingival crevicular fluid (GCF)

    Differences in the GCF of regeneration-related marker concentrations between test and control groups

    Time frame: Baseline, 4 weeks,

  2. Microbiological changes in microbial plaque

    Differences in the microbial profile between test and control groups

    Time frame: Baseline, 4 weeks,

  3. 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.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Aug 2026, 21 months after the start.

Of 88 non-industry interventional studies with no phase under Chronic Periodontitis, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 24. This study's planned 21 months is above that.

Counting every sponsor, half of 89 studies reached it within 15 months; a quarter within 10 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 5, 2024
First posted
Nov 12, 2024
StartActual
Nov 15, 2024
Primary completionEst.
Aug 2026
CompletionEst.
Nov 2026
Last update
Sep 8, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06684769
Lead sponsor
Riga Stradins University
Collaborators
University of Turku, University of Oslo, Labrida AS
Responsible party
Anete Vaškevica (Lectureur, Riga Stradins University) — Principal investigator
First posted
Nov 12, 2024
Start date
Nov 15, 2024
Primary completion
Aug 2026 (estimated)
Completion
Nov 2026 (estimated)
Last update
Sep 8, 2025

Study contacts

Anete Vaškevica, DDS
Contact
anete.vaskevica@rsu.lv
+37120202028
Dārta E Emuliņa, DDS
Contact
dartaemulina@gmail.com
+37122007988
Ilze Akota, PhD
study chair · Riga Stradins University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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