Clinical trial NCT06684769: 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 Parallel Arm Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Periodontitis, Adult
Furcation Defects
Furcation of Root of Tooth
Periodontitis Complex
Lead sponsor: Riga Stradins University
Sponsor class: OTHER
Collaborators: name: University of Turku
name: University of Oslo
name: Labrida AS
First posted: 2024-11-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised, single-blinded parallel arm clinical trial
Primary purpose: TREATMENT

Brief 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 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 the study
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 (stage III or IV)
5. 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.)
6. Buccal and/or lingual Class 2A and/or 2B furcation involvement defects on the mandibular first and/or second molars after completing the first and second steps of periodontal treatment.
7. Buccal Class 2A and/or 2B furcation involvement defects on 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.
8. Psychological appropriateness
9. Consents to all follow-up visits

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 if there are clinically visible hyperplastic changes in the gingival margin.
4. 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
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/or consulting 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 complete periodontal 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 or furcation 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 into the furcation area
20. Clinical attachment level and or pockets mesial and distal to the furcation involvement 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.

Primary outcomes:
measure: Modified Bleeding on Probing index (mBoP)
timeFrame: Baseline, 12 weeks
measure: Probing Pocket Depth (PPD) in mm
timeFrame: Baseline,12 weeks
measure: Clinical Attachment Level (CAL) in mm
timeFrame: Baseline, 12 weeks
measure: Furcation Involvement 1
timeFrame: Baseline, 12 weeks
measure: Furcation Involvement 2 in mm
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Proteomic profile of gingival crevicular fluid (GCF)
timeFrame: Baseline, 4 weeks,
measure: Microbiological changes in microbial plaque
timeFrame: Baseline, 4 weeks,
measure: Visual analog scale (VAS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Riga
country: Latvia
facility: Riga Stradins University Institute of Stomatology
Study officials:
affiliation: Riga Stradins University
name: Ilze Akota, PhD
role: STUDY_CHAIR
References: