Periodontal regeneration after severe periodontitis using cell therapy. Oral Health Periodontitis
Conditions
Interventions
1. Experimental group (10 patients): 100mg hydroxyapatite-collagen scaffold (Bio-Oss-Collagen®, Geistlich Pharma AG, Suiza) with 10x106 autologous periodontal ligament- derived mesenchymal stem cells
Sponsors
Department of Pharmacy and Health Products (Dirección General de Farmacia y Productos Sanitarios) Spanish Ministry of Health.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients from 25 to 70 years old (women in fertile age will need a negative urine pregnancy test and will be willing to use contraception with a failure rate <1% (oral contraceptives, double barrier method, intrauterine devices) 2. Absence of relevant medical condition 3. Non-smoker patients 4. Patients with moderate-severe chronic Periodontitis, treated with non-surgical periodontal therapy in the School of Dentistry of Complutense University (Madrid). 5. Patients with at least one tooth with clinical attachment level loss greater than 5mm and a 1-2 wall intrabony defect deeper than 4mm 6. Patients with at least one tooth with a hopeless prognosis or third molars, planned to be extracted 7. Band of keratinized gingiva of at least 2mm at the level of the tooth with the intrabony defect 8. Patients with good oral hygiene (Plaque Index lower than 25%) 9. Patients with optimal compliance
Exclusion criteria
Exclusion criteria: 1. Patients in which the teeth intended to regenerate have type III mobility, type III furcation involvement, periapical pathology and vertical root fracture 2. Patients with aggressive periodontitis 3. Pregnant and lactating woman 4. Patients with diseases that affect connective tissue metabolism 5. Patients with history of rapidly progressive dementia/ neurological illness of unknown etiology 6. Patients with previous treatment with pituitary-derived hormone 7. Patients with uncontrolled infection (systemic/ local in the tissue of interest) 8. Patients with history, risk factors, clinical evidence or positive tests for HIV, HBV, HCV and HTLV I/II. 9. Patients with history of chronic autoimmune disease that can have caused injury of the tissues of interest 10. Patients with disease-transmission risk factors related to travelling history and local prevalence of local infections 11. Patients with Diseases that affect connective tissue metabolism 12. Patients with Risk of invalidation of diagnostic tests due to hemodilution or immunosuppressive-treatment. 13. Patients with Presence of physical signs that may entail a risk for disease transmission 14. Patients with history of recent vaccination with attenuated virus that may entail a source of infection 15. Patients who have participated in an intervention clinical trial in the same quadrant in the last 2 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Safety parameters: presence/absence of adverse reactions/events 1, 2, 4, 12, 24 and 36 weeks and 12, 24, 36, 48 and 60 months after the intervention. (Presence=1; Absence=0) 2. Efficacy parameters: clinical attachment level gains measured at 12 months, (in mm.) with a computerized pressure-controlled periodontal probe (Florida Probe®, Florida Probe Corporation, FL, USA). Clinical attachment level measurements will be performed at baseline, 24 and 36 weeks and 12 months after the intervention by a trained and calibrated examiner. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Probing Pocket Depth reduction (in mm.) measured with a computerized pressure-controlled periodontal probe (Florida Probe®, Florida Probe Corporation, FL, USA). Measurements will be performed at baseline, 24 and 36 weeks and 12 months after the intervention by a trained and calibrated examiner 2. Changes in gingival recession (in mm.) measured with a computerized pressure-controlled periodontal probe (Florida Probe®, Florida Probe Corporation, FL, USA). Measurements will be performed at baseline, 6, 9 and 12 months after the intervention by a trained and calibrated examiner 3. Radiographic bone fill measured in standardized periapical x-rays performed with long cone technique and bite blocks at baseline, immediately after surgery and at 3, 6, 9 and 12 months by a trained and calibrated examiner. Measurements (in mm.) done in DBSWIN imaging software (DentaScan): radiographic bone fill= (Alveolar bone crest-cementoenamel junction)-(base of the defect-cementoenamel junction) 4. Patient-based quality of life assessment by using a patient-self reported questionnaire (OHIP) at baseline and 12 months 5. Tooth loss at 12 months 6. Patient-based aesthetic outcomes by using a VAS scale (1-10) at 12 months 7. Postoperative morbidity: wound healing assessment at 1, 2 and 4 weeks after intervention (1. Complete closure; 2. Thin fibrin line; 3. Fibrin; 4. Incomplete closure; 5. Necrosis) | — |
Countries
Spain
Contacts
Public ContactNerea Sánchez
Outcome results
None listed