Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06684769

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

Led by Riga Stradins University · Updated on 2025-09-08

40

Participants Needed

1

Research Sites

102 weeks

Total Duration

On this page

Sponsors

R

Riga Stradins University

Lead Sponsor

U

University of Turku

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is 18 years of age or older
  • No systemic diseases that may affect study results
  • Plaque index of 20% or less at study entry
  • History of severe localized or generalized periodontitis (stage III or IV)
  • Completed first and second steps of periodontal treatment
  • Buccal and/or lingual Class 2A or 2B furcation defects on mandibular first or second molars after treatment
  • Buccal Class 2A or 2B furcation defects on maxillary first or second molars after treatment if palatal furcation involvement does not exceed Class 1
  • Psychological appropriateness
  • Consent to all follow-up visits
Not Eligible

You will not qualify if you...

  • Systemic diseases that may affect study results
  • Use of medications affecting study results (anti-osteoporotic drugs, statins, corticosteroids, anticoagulants)
  • Use of calcium channel blockers, cyclosporine A, or antiepileptic drugs with visible gingival hyperplasia
  • Systemic antibiotics use within six months before study or during study
  • Need for antibiotic premedication before periodontal treatment
  • Oncological disease
  • Active or history of chemotherapy or radiotherapy
  • Pregnancy or breastfeeding
  • Any condition or treatment posing unreasonable risk per investigator or physician
  • Psychoemotional disorders or depression
  • Use of antipsychotic medication or antidepressants
  • Lack of motivation for dental care or incomplete periodontal treatment
  • Residing outside Latvia
  • Molars with combined endodontic-periodontal lesions or active endodontic infection
  • Prosthetic factors preventing clinical measurements on molars
  • Large restorations or amalgam fillings risking fractures or furcation involvement
  • Presence of enamel pearls or filling/crown margins
  • Tooth decay or root resorption
  • Tooth mobility degree 3
  • Gingival margin positioned apically to furcation entrance
  • Clinical attachment level or pockets of 6 mm or more mesial or distal to furcation defect
  • Strong vomiting reflex preventing adequate periodontal treatment
  • Close relations to study subjects such as colleagues or relatives

AI-Screening

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Trial Site Locations

Total: 1 location

1

Riga Stradins University Institute of Stomatology

Riga, Latvia

Actively Recruiting

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Research Team

A

Anete Vaškevica, DDS

CONTACT

D

Dārta E Emuliņa, DDS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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