Dental ridge contour deficiency Oral Health
Conditions
Interventions
OSSIX® Volumax is a biodegradable and biocompatible collagen scaffold designed to support the formation of new alveolar bone and new attachment apparatus in teeth when the technique of Guided bone/tis
Sponsors
Datum Dental
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females =18 years 2. General good health (ASA 1 and ASA 2) 3. Presence of a tissue contour deficiency leading to an unesthetic implant rehabilitation, not associated with bone dehiscence and/or fenestration defects. 4. Patients require 1-3 implants placed between two periodontally stable natural teeth. 5. Good oral hygiene (full mouth plaque index <25%) 6. Adequate control of inflammation (full mouth bleeding on probing <25%) 7. Patients that are willing to sign an informed consent and participate in the clinical study 8. Patient that are able to understand and to comply with the study related procedures such as exercising good oral hygiene and attending all follow-up examinations
Exclusion criteria
Exclusion criteria: 1. Implant sites with associated alveolar bone dehiscence and/or fenestration defects that necessitate bone grafting in combination with correction of ridge contour deficiency. 2. General contraindications for dental and/or surgical treatments 3. Inflammatory and autoimmune disease of the oral cavity 4. Allergy to collagen 5. Uncontrolled diabetes (A1C > 6.5 %) 6. Disease of oral mucosa 7. Disease affecting connective tissue metabolism (e.g. collagenases) 8. Uncontrolled Periodontal disease 9. History of myeloma, respiratory tract cancer, breast cancer, prostate cancer, or kidney cancer requiring chemotherapy or radiotherapy. 10. Concurrent or previous radiotherapy of head area 11. Concurrent or previous immunosuppressant, bisphosphonate, or high-dose corticosteroid therapy 12. Heavy Smokers (over 10 cigarettes a day) 13. Pregnant or lactating women. 14. Women of childbearing age, who are not using a highly effective method of birth control 15. Participation in another investigational device, drug, or biologics study within the last 24 weeks prior to the study start.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measuring the width of the ridge by intra oral scanner at 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Volumetric changes of the augmented site calculated by intraoral scan impression (mm³) at 6 and 12 months 2. Soft tissue healing measured by clinical evaluation at the surgery site at 6 and 12 months: 2.1. Keratinized tissue width on the buccal side of the two neighboring teeth; measured from a fixed referenced point to the mucogingival line (mm) 2.2. Wound closure (according to the wound healing index) at all time points. 2.3. Membrane/scaffold exposure, color, redness, and swelling, inflammation 2.4. Bleeding on probing (BOP) 2.5. Periodontal probing depth (PPD) 2.6. Clinical attachment level (CAL) 2.7. Recession depth (RD) Exploratory: 1. Evaluation of OSSIX® Volumax clinical bone formation parameters from CBCT superposition: 1.1. Radiographic bone changes (horizontal and vertical) change in mm at 12 months 1.2. Implant stability (ISQ) and survival at 12 months 2. Esthetic outcome determined by a masked and calibrated examiner evaluated the results with predefined questionnaire at 12 months 3. Patient subjective oral health impact profile will be assessed with the OHIP-14 questionnaire at 2 weeks 4. Documentation of the related adverse events at all visits Safety: 1. The safety will be assessed by evaluation of the number and severity of documented adverse events such as wound closure complications) and concomitant medications that will be recorded at all visits during the entire study period. | — |
Countries
Italy
Outcome results
None listed