Actively Recruiting
Non-surgical Treatment of Mandibular and Maxillary Molar Furcations Using a Chitosan Brush With or Without Enamel Matrix Derivative: A Split-mouth Randomized Clinical Trial
Led by Riga Stradins University · Updated on 2025-09-08
40
Participants Needed
1
Research Sites
13 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
Researchers are evaluating non-surgical treatment options for patients with stage III or IV periodontitis who have specific Class II buccal and/or lingual furcation defects in their mandibular and maxillary molars. This prospective, randomized, single-blinded clinical trial uses a split-mouth design to compare treatments and is conducted at Riga Stradins University Institute of Stomatology in Latvia. Patients receive detailed oral hygiene instructions before treatment begins to ensure proper care. The study compares two treatments: the test side receives an oscillating chitosan brush combined with enamel matrix derivatives, while the control side receives the oscillating chitosan brush alone. Treatment is applied to furcation defects at baseline. The trial includes a 12-week re-evaluation period after baseline treatment. Biofilm and gingival crevicular fluid samples are collected at baseline and again at 4 weeks to monitor biological changes. Participants undergo clinical assessments including bleeding on probing, probing pocket depth, clinical attachment level, and furcation involvement measurements at baseline and 12 weeks. Proteomic and microbiological analyses of gingival fluid and plaque samples are performed at baseline and 4 weeks. Patient comfort is measured using a visual analog scale at baseline. The trial involves follow-up visits to monitor periodontal status and treatment effects over 12 weeks.
CONDITIONS
Brief Title
A Chitosan Brush and Enamel Matrix Derivative for Non-surgical Treatment of Furcations
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- No systemic diseases affecting 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
- Buccal Class 2A or 2B furcation defects on maxillary first or second molars with palatal furcation involvement no more than Class 1
- Psychologically appropriate
- Consent to all follow-up visits
You will not qualify if you...
- Systemic diseases that may affect study results
- Use of medications like anti-osteoporotic drugs, statins, corticosteroids, anticoagulants
- Use of calcium channel blockers, cyclosporine A, or antiepileptic drugs with visible gingival hyperplasia
- Use of systemic antibiotics in the last six months or starting antibiotics during the study
- Need for antibiotic premedication before periodontal treatment
- Active or history of oncological disease, chemotherapy, or radiotherapy
- Pregnancy or breastfeeding
- Conditions or treatments posing unreasonable risks
- Psychoemotional disorders or depression
- Use of antipsychotic medication or antidepressants
- Lack of motivation for dental care or residing outside Latvia
- Molars with combined endodontic-periodontal lesions or active endodontic infection
- Prosthetic factors preventing clinical measurements
- Large restorations or fillings risking fractures or furcation involvement
- Enamel pearls or filling or crown margins
- Decay or root resorption
- Tooth mobility degree 3
- Gingival margin positioned apically below furcation entrance
- Clinical attachment level or pockets mesial/distal to furcation defect of 6 mm or more
- Strong vomiting reflex preventing periodontal treatment
- Close relations to study subjects such as colleagues or relatives
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Baseline day
Participants receive non-surgical treatment of molar furcations using an oscillating chitosan brush with or without enamel matrix derivative.
1 baseline visit (in-person)
Duration - Up to 12 weeks
Participants are monitored to assess clinical outcomes and changes after treatment.
2 visits at 4 and 12 weeks (in-person)
Trial Site Locations
Total: 1 location
1
Riga Stradins University Institute of Stomatology
Riga, Latvia
Actively Recruiting
Research Team
A
Anete Vaškevica, DDS
D
Dārta E Emuliņa, DDS
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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