Periodontal disease Localized deep pockets on furcation grade II involved molars Oral Health Periodontal disease Localized deep pockets on furcation grade II involved molars
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years 2. Presence of at least one molar with furcation involvement 2, with horizontal CAL >3 mm and residual pocket after non-surgical therapy of =5 mm 3. < 20 % full mouth plaque score (FMPS) 4. < 30 % full mouth bleeding score (FMBS)
Exclusion criteria
Exclusion criteria: 1. Uncontrolled diabetes 2. HIV 3. Leukopenia 4. Any systemic diseases related to reduced healing potential 5. Allergy to any medication related with the study protocol (paracetamol, xilocaine) 6. Pregnancy or lactation 7. Daily use of any medication suppressive for the immune system (corticosteroid or immunosuppressant) 8. Antibiotics use before the study enrolment 9. Third molars 10. Terminal bone loss 11. Endodontically and non-endodontically treated teeth with periapical radiolucency 12. Periapical radiolucency or vertical fracture. 13. Tooth mobility >1 14. Furcation involvement grade 0, 1 or 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline and at the 6 month follow-up using a Nabers probe: 1. Change in Horizontal Clinical Attachment Level (HCAL), 2. Furcation involvement | — |
Secondary
| Measure | Time frame |
|---|---|
| The following are assessed at the baseline and at the 6 month follow-up (unless otherwise stated): 1. Change in Vertical Clinical Attachment Level (VCAL), assessed using the Michigan O periodontal probe with Williams markings. VCAL is defined as the distance between the cement-enamel junction and the bottom of the periodontal pocket 2. Change in Probing Pocket Depth (PPD), assessed using the Michigan O periodontal probe with Williams markings. PPD is defined as the distance between the sulcus and the bottom of the periodontal pocket 3. Bleeding on probing (BOP), assessed by the number of gingival units that bleed upon probing. Bleeding sites are scored as 0 = no bleeding, 1 = pinprick bleeding and 2 = excessive bleeding 4. Bone fill, assessed using the Michigan O peridoontal probe with Williams markings. Bone fill is expressed as the difference between this measurement at the baseline and at the 6 month follow-up 5. Wound healing, assessed using the Early Wound Healing Index (EWHI) and recorded with intraoral clinical photographs at days 3, 7 and 14, week 6 and month 3 post-surgery 6. Postoperative morbidity, assessed using questionnaires (visual analogue score (VAS)) at the end of the day, daily, for the first week post-surgery, and then at day 14, week 6 and month 3 post-surgery. 7. Acceptance of procedure, assessed using the post-operative questionnaire after surgery 8. Biomarkers in gingival crevicular fluid (GCF) and peripheral blood as a possible predictor of early and long-term clinical wound healing. GCF will be collected using a paper strip from the sulcus of the deepest pocket at the baseline and at days 3, 7 and 14, week 6, and 3 and 6 months post-surgery. The following biomarkers will be analysed: 8.1. Albumin (as a reference parameter to measure the relative amount of other proteins) 8.2. Growth factors, including VEGF, EGF, IGF and PDGF 8.3. Inflammatory cytokines, including IL-1, IL-2, IL-12, TNF-a, TGF-ß, matrix metalloproteinases (MMPs) | — |
Countries
Netherlands