What is this study testing for patients with periodontitis?

This study is comparing two non-surgical treatments for advanced periodontitis affecting molar furcation areas. Researchers want to understand if adding enamel matrix derivatives to an oscillating chitosan brush improves treatment outcomes. The trial is conducted by Riga Stradins University and focuses on managing difficult furcation defects.

Who may be eligible for this periodontitis clinical trial?

Adults aged 18 or older with stage III or IV periodontitis involving specific furcation defects in molars may be eligible. Participants must have good plaque control and no systemic diseases affecting the study. Those who have taken antibiotics recently or have certain dental or medical conditions may be excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this periodontitis clinical trial?

Study-related care, including the study devices and all trial visits, is provided at no cost. Personal expenses such as travel to and from the study site may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years +

All Genders

ID06684769

Non-surgical Treatment of Molar Furcation Defects Using a Chitosan Brush With or Without Enamel Matrix Derivative A Randomized Split-Mouth Clinical Trial

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

Participants Needed

Research Sites

13 weeks

Total Duration

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 andor 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

Age: 18Years +

All Genders

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

Research Team

Anete Vaškevica, DDS

Dārta E Emuliņa, DDS

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