reconstruction of atrophied alveolar in patients with partial edentulism
Conditions
Sponsors
Geistlich Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Written informed consent - Age 18 years or older - Partial edentulism - Surgical site characteristics: - Atrophied alveolar ridge with one or more adjacent missing teeth - Atrophied alveolar ridge with residual ridge width of = 4 mm - Sufficient bone height at the surgical site for implant placement
Exclusion criteria
Exclusion criteria: - General contraindications for dental and/or surgical treatments - Periodontitis - Peri-implantitis - Probing depth > 4mm at the adjacent teeth Inadequate oral hygiene (PI>1) - Knife-edge morphology of the alveolar ridge - Insufficient bone for bone block harvesting from ramus mandibulae - Edentulous area not larger than 4 missing teeth - Implants adjacent to the surgical site - Inflammatory disease of oral cavity - Immunological impairment - Allergy to collagen - Diabetes - History of myeloma, respiratory tract cancer, breast cancer, prostate cancer or kidney cancer requiring chemotherapy or radiotherapy within the past five years - Previous, concurrent or planned radiotherapy of head area - Concurrent or previous immunosuppressant, bisphosphonate, high-dose or long-term corticosteroid therapy - Smokers or subjects who did not quit smoking at least 3 months prior to the surgery - Pregnant or lactating women - Women of child bearing age, who are not using a highly effective method of birth control - Participation in an investigational device, drug or biologics study within the last 26 weeks prior to the study start - Participation in any other clinical investigation during the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Target ridge width increase 2 mm below the crest after 30 weeks of healing (mm) assessed with calibrated manual caliper. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Evaluation of AEs and occurence of dehiscence at donor and receipient surgical sites Performance: Ridge width 2 mm below the crest at the baseline (before graft placement) and after 30 weeks of healing (mm) using calibrated manual caliper Implant placement after 30 weeks of healing possible (y/n) Ridge width 2 mm below the crest at the baseline after block graft placement (mm) using calibrated manual caliper Number of target sites where contouring with Deproteinized Bovine Bone Mineral (DBBM) and Collagen Membrane (CM) at implant placement is indicated Graft removal during 30 weeks of healing (complete/partial/no) Surgery duration at V2 (including harvesting surgery) (min) Subject’s pain sensation in the oral cavity during the 10 days post augmentation surgery (at V2 + 10 days) according to subject’s diary (VAS) Subject’s analgesic medication consumption (mg) at augmentation surgery (V2) and during the 10 days post-surgery, according to subject’s diary Subject’s Oral Health Impact Profile score (OHIP-14) before augmentation surgery (at V2) and 4 weeks after augmentation surgery (V4) Subject’s outcome satisfaction at implant loading (V10) assessed with subject’s questionnaire (VAS) | — |
Countries
Brazil
Contacts
Public ContactGiuseppe Romito
University of Sao Paulo FOUSP - USP School of dentistryAv. Prof. Lineu Prestes, 2227Cidade Universitaria Butana
Outcome results
None listed