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

NCT06684769 | Recruiting

• 1 other identifier: 2-PĒK-4/659/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis, Adult; Furcation Defects; Furcation of Root of Tooth; Periodontitis Complex

Outcome Measures

Primary Outcomes (5)

• 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

  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 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

  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

Secondary Outcomes (3)

• Proteomic profile of gingival crevicular fluid (GCF)

  Baseline, 4 weeks,

• Microbiological changes in microbial plaque

  Baseline, 4 weeks,

• Visual analog scale (VAS)

  Baseline

Study Arms (2)

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

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

Device: Labrida BioClean®

Interventions

Emdogain® FL DEVICE

Enamel Matrix Derivatives

Chitosan brush with Emdogain FL

Labrida BioClean® DEVICE

Oscillating Chitosan Brush

Chitosan brush alone; Chitosan brush with Emdogain FL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riga Stradins University: lead
• University of Turku: collaborator
• University of Oslo: collaborator
• Labrida AS: collaborator

Study Sites (1)

Riga Stradins University Institute of Stomatology

Riga, Latvia

RECRUITING

MeSH Terms

Conditions

Chronic Periodontitis; Furcation Defects

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ilze Akota, PhD

  Riga Stradins University

  STUDY CHAIR

Central Study Contacts

Anete Vaškevica, DDS

CONTACT

+37120202028; anete.vaskevica@rsu.lv

Dārta E Emuliņa, DDS

CONTACT

+37122007988; dartaemulina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lectureur

Model Details: Randomised, single-blinded, split-mouth clinical trial

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 12, 2024
• Study Start: November 15, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

LA (1)