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NCT Number: NCT06684769

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

Exclusion criteria

  • 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
  • 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.

Treatment and study plan

Emdogain® FL

Device

Enamel Matrix Derivatives

Labrida BioClean®

Device

Oscillating Chitosan Brush

Primary outcomes

  1. Modified Bleeding on Probing index (mBoP)

    Time frame: Baseline, 12 weeks

    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
  2. Probing Pocket Depth (PPD) in mm

    Time frame: Baseline,12 weeks

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

  3. Clinical Attachment Level (CAL) in mm

    Time frame: Baseline, 12 weeks

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

  4. Furcation Involvement 1

    Time frame: Baseline, 12 weeks

    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
  5. Furcation Involvement 2 in mm

    Time frame: Baseline, 12 weeks

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

Secondary outcomes

  1. Proteomic profile of gingival crevicular fluid (GCF)

    Time frame: Baseline, 4 weeks,

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

  2. Microbiological changes in microbial plaque

    Time frame: Baseline, 4 weeks,

    Differences in the microbial profile between test and control groups

  3. Visual analog scale (VAS)

    Time frame: Baseline

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Anete Vaškevica, DDS

CONTACT

[email protected]

+37120202028

Dārta E Emuliņa, DDS

CONTACT

[email protected]

+37122007988

Sponsors and collaborators

Lead sponsor

Riga Stradins University

Other

Collaborators

  • Labrida AS
  • University of Oslo
  • University of Turku

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 12, 2024
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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