Status:
RECRUITING
A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
Lead Sponsor:
Riga Stradins University
Collaborating Sponsors:
University of Turku
University of Oslo
Conditions:
Periodontitis, Adult
Furcation Defects
Eligibility:
All Genders
18+ years
Phase:
NA
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 probi...
Eligibility Criteria
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.
Key Trial Info
Start Date :
November 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06684769
Start Date
November 15 2024
End Date
November 1 2026
Last Update
September 8 2025
Active Locations (1)
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1
Riga Stradins University Institute of Stomatology
Riga, Latvia