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

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.

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.

Study Overview

• Status: Recruiting
• Conditions: Furcation Defects; Periodontitis, Adult; Periodontitis Complex; Furcation of Root of Tooth
• Intervention / Treatment: Device: Emdogain® FL; Device: Labrida BioClean®

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anete Vaskevica, DDS; Phone Number: +37120202028; Email: anete.vaskevica@rsu.lv
• Study Contact Backup: Name: Dārta E Emuliņa, DDS; Phone Number: +37122007988; Email: dartaemulina@gmail.com

Study Locations

• Latvia
  • Riga, Latvia
    • Recruiting
    • Riga Stradins University Institute of Stomatology
    • Contact: Anete Vaskevica, DDS; Phone Number: +37120202028; Email: anete.vaskevica@rsu.lv
    • Contact: Dārta E Emuliņa, DDS; Phone Number: +37122007988; Email: dartaemulina@gmail.com
    • Principal Investigator: Anete Vaskevica, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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:

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, corticosteroids, 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Enamel Matrix Derivatives; Device: Labrida BioClean®; Oscillating Chitosan Brush
Sham Comparator: Chitosan brush alone; Furcation Involved areas will be treated with the oscillating chitosan brush Labrida BioClean® at Baseline	Device: Labrida BioClean®; Oscillating Chitosan Brush

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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; 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	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
Probing Pocket Depth (PPD) in mm	Pseudo marker of inflammation, lower scores mean a better outcome.	Baseline,12 weeks

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Riga Stradins University
• Collaborators: University of Oslo; University of Turku; Labrida AS
• Investigators: Study Chair: Ilze Akota, PhD, Riga Stradins University

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: November 5, 2024
• First Submitted That Met QC Criteria: November 9, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Estimated): September 8, 2025
• Last Update Submitted That Met QC Criteria: August 31, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Chronic Disease; Disease Attributes; Periodontitis; Pathological Conditions, Signs and Symptoms; Furcation Defects; Chronic Periodontitis
• Other Study ID Numbers: 2-PĒK-4/659/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No