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

Last updated: February 24, 2025
Sponsor: Riga Stradins University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Periodontitis

Treatment

Labrida BioClean®

Emdogain® FL

Clinical Study ID

NCT06684769
2-PĒK-4/659/2024
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 thestudy

  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 (stageIII or IV)

  5. Completed the first and second steps of periodontal treatment (According toTreatment 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 defects on themandibular first and/or second molars after completing the first and second steps ofperiodontal treatment.

  7. Buccal Class 2A and/or 2B furcation involvement defects on the maxillary firstand/or second molars after completion of the first and second step of periodontaltreatment if furcation involvement on the palatal side (mesiopalatal anddistopalatal) does not exceed Class 1.

  8. Psychological appropriateness

  9. Consents to all follow-up visits

Exclusion

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 ifthere are clinically visible hyperplastic changes in the gingival margin.

  4. Patients who have received any type of systemic antibiotics in the last six monthsprior 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/orconsulting 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 completeperiodontal 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 orfurcation 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 intothe furcation area

  20. Clinical attachment level and or pockets mesial and distal to the furcationinvolvement 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

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Labrida BioClean®
Phase:
Study Start date:
November 15, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Riga Stradins University Institute of Stomatology

    Riga,
    Latvia

    Active - Recruiting

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