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

Official title

Non-surgical Treatment of Mandibular and Maxillary Molar Furcations With a Chitosan Brush With Adjunct Enamel Matrix Derivative- a Split-mouth Randomized Clinical Trial

Overview

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.

Interventions

• Device Emdogain® FL
  Enamel Matrix Derivatives
• Device Labrida BioClean®
  Oscillating Chitosan Brush

Primary outcome measures

• Modified Bleeding on Probing index (mBoP) [Time frame: Baseline, 12 weeks]
• Probing Pocket Depth (PPD) in mm [Time frame: Baseline,12 weeks]
• Clinical Attachment Level (CAL) in mm [Time frame: Baseline, 12 weeks]
• Furcation Involvement 1 [Time frame: Baseline, 12 weeks]
• Furcation Involvement 2 in mm [Time frame: Baseline, 12 weeks]

Secondary outcome measures (3)

• Proteomic profile of gingival crevicular fluid (GCF) [Time frame: Baseline, 4 weeks,]
• Microbiological changes in microbial plaque [Time frame: Baseline, 4 weeks,]
• Visual analog scale (VAS) [Time frame: Baseline]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Latvia · 1 center

• Riga Stradins University Institute of Stomatology — Riga

Identifiers

NCT: NCT06684769 · 2-PĒK-4/659/2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗