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

Not Applicable

Recruiting

• Conditions: Periodontitis, Adult; Furcation Defects; Furcation of Root of Tooth; Periodontitis Complex

• Registration Number: NCT06684769
• Lead Sponsor: Riga Stradins University

Brief Summary

Patients diagnosed with stage III or IV periodontitis that 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 that 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 parallel arm 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 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 in test group will be performed through the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives and in the control group 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-09
• Study First Posted: 2024-11-12
• Study Start: 2024-11-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2026-08
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Modified Bleeding on Probing index (mBoP)	Baseline, 12 weeks	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
Furcation Involvement 1	Baseline, 12 weeks	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
Probing Pocket Depth (PPD) in mm	Baseline,12 weeks	Pseudo marker of inflammation, lower scores mean a better outcome.
Clinical Attachment Level (CAL) in mm	Baseline, 12 weeks	Marker of gain in attachment, lower scores mean a better outcome
Furcation Involvement 2 in mm	Baseline, 12 weeks	Marker of gain in attachment, Horizontal Furcation involvement measurement using UNC 15mm probe, lower scores mean a better outcome

Secondary Outcome Measures

Name	Time	Method
Proteomic profile of gingival crevicular fluid (GCF)	Baseline, 4 weeks,	Differences in the GCF of regeneration-related marker concentrations between test and control groups
Microbiological changes in microbial plaque	Baseline, 4 weeks,	Differences in the microbial profile between test and control groups
Visual analog scale (VAS)	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.

Trial Locations

Locations (1)

Riga Stradins University Institute of Stomatology; 🇱🇻 Riga, Latvia