Furcation Defects, Furcation of Root of Tooth, Periodontitis, Adult, Periodontitis Complex
Conditions
Brief summary
Patients diagnosed with stage III or IV periodontitis who 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 who 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 split-mouth 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' furcation defects in each quadrant 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 on the test side will be performed through the application of Oscillating Chitosan Brush with Enamel Matrix Derivatives and on the control side 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.
Interventions
DEVICEEmdogain® FL
Enamel Matrix Derivatives
DEVICELabrida BioClean®
Oscillating Chitosan Brush
Sponsors
University of Turku
University of Oslo
Labrida AS
Riga Stradins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomised, single-blinded, split-mouth clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Furcation Involvement 2 in mm | Baseline, 12 weeks | Marker of gain in attachment, Horizontal Furcation involvement measurement using UNC 15mm probe, lower scores mean a better outcome |
| Probing Pocket Depth (PPD) in mm | Baseline,12 weeks | Pseudo marker of inflammation, lower scores mean a better outcome. |
| Clinical Attachment Level (CAL) in mm | Baseline, 12 weeks | Marker of gain in attachment, lower scores mean a better outcome |
| Furcation Involvement 1 | Baseline, 12 weeks | Marker of gain in attachment, Horizontal Furcation involvement measurement using Nabers Probe 1. Horizontal loss of periodontal tissue support less than 3 mm 2. Horizontal loss of support 3 mm or more, but not encompassing the total width of the furcation 3. Horizontal through-and-through destruction of the periodontal tissue in the furcation Lower scores mean a better outcome |
| Modified Bleeding on Probing index (mBoP) | Baseline, 12 weeks | Pseudo marker of inflammation, lower scores mean a better outcome 0 = no bleeding; 1. = a bleeding spot; 2. = a bleeding line; 3. = pronounced bleeding within 30 seconds following probing of the pocket |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological changes in microbial plaque | Baseline, 4 weeks, | Differences in the microbial profile between test and control groups |
| Visual analog scale (VAS) | Baseline | Evaluation of self-perceived pain using a 100 mm Visual analog scale (range 0 - 100) at baseline treatment visit; 0 - no pain, 100 - worst pain ever felt. Lower scores mean a better outcome. |
| Proteomic profile of gingival crevicular fluid (GCF) | Baseline, 4 weeks, | Differences in the GCF of regeneration-related marker concentrations between test and control groups |
Countries
Latvia
Contacts
Primary ContactAnete Vaškevica, DDS
Backup ContactDārta E Emuliņa, DDS
Outcome results
None listed