Non-surgical treatment for gum disease using chitosan and enamel matrix
Non-surgical Treatment of Mandibular and Maxillary Molar Furcations With a Chitosan Brush With Adjunct Enamel Matrix Derivative- a Split-mouth Randomized Clinical Trial
This study is testing a new non-surgical treatment using a special brush and gel to help people with advanced gum disease and specific tooth issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Riga Stradins University Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Riga) |
| Trial ID | NCT06684769 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a chitosan brush combined with an enamel matrix derivative for the non-surgical treatment of furcation defects in patients with stage III or IV periodontitis. Participants will be randomly assigned to receive either the experimental treatment or a control intervention after receiving detailed oral hygiene instructions. The study will focus on patients with specific types of furcation defects in their molars, ensuring a targeted approach to treatment. The trial will be conducted at the Riga Stradiņš University Institute of Stomatology in Latvia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with stage III or IV periodontitis and specific furcation defects in their molars.
Not a fit: Patients with systemic diseases affecting periodontal health or those who have not completed prior periodontal treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve periodontal health and reduce the need for surgical interventions in patients with advanced gum disease.
How similar studies have performed: While similar approaches have been explored, this specific combination of treatments is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 (FI) defects on both sides of 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 (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. 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.
Where this trial is running
Riga
- Riga Stradins University Institute of Stomatology — Riga, Latvia (Recruiting)
Study contacts
- Study coordinator: Anete Vaškevica, DDS
- Email: anete.vaskevica@rsu.lv
- Phone: +37120202028
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.