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

Launched by RIGA STRADINS UNIVERSITY · Nov 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new non-surgical treatment for patients with severe gum disease (periodontitis) who have specific defects in the area where the roots of their teeth meet. The treatment involves using a special brush that incorporates a material called enamel matrix derivatives, which may help improve gum health and healing. The trial is open to adults aged 18 and older who have already undergone initial periodontal treatments and meet certain criteria regarding their gum condition.

Participants will be randomly assigned to receive either the new treatment with the special brush and enamel matrix or just the brush alone. Before starting, all participants will receive guidance on maintaining good oral hygiene. After 12 weeks, their gum health will be re-evaluated. This trial is being conducted at the Riga Stradiņš University Institute of Stomatology in Latvia, and it is important for participants to be committed to follow-up visits and have no major health conditions that could interfere with the results.

Gender

ALL

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.