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

ConditionsPeriodontitis, AdultFurcation DefectsFurcation of Root of ToothPeriodontitis Complex
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRiga Stradins University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Emdogain® FL

    Device

    Enamel Matrix Derivatives

  • Labrida BioClean®

    Device

    Oscillating Chitosan Brush

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Chitosan brush with Emdogain FLExperimental treatment 2 interventions
Group B: Chitosan brush aloneSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Modified Bleeding on Probing index (mBoP)

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

Time frame
Baseline, 12 weeks
2

Probing Pocket Depth (PPD) in mm

Pseudo marker of inflammation, lower scores mean a better outcome.

Time frame
Baseline,12 weeks
3

Clinical Attachment Level (CAL) in mm

Marker of gain in attachment, lower scores mean a better outcome

Time frame
Baseline, 12 weeks
4

Furcation Involvement 1

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

Time frame
Baseline, 12 weeks

Secondary outcomes

1

Proteomic profile of gingival crevicular fluid (GCF)

Differences in the GCF of regeneration-related marker concentrations between test and control groups

Time frame
Baseline, 4 weeks,
2

Microbiological changes in microbial plaque

Differences in the microbial profile between test and control groups

Time frame
Baseline, 4 weeks,
3

Visual analog scale (VAS)

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.

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Riga Stradins University

Lead sponsor

University of Turku

Collaborator

University of Oslo

Collaborator

Labrida AS

Collaborator

Source ClinicalTrials.gov
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