K00-K14
Conditions
Interventions
Group 1: Placement of the implant simultaneously with L-shaped deproteinized bovine-derived bone mineral with 10% of Collagen and a collagen membrane
Group 2: Placement of the implant simultaneously w
Sponsors
Clinic of Reconstructive DentistryCenter of Dental MedicineUniversity of Zürich
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: -Patients, in need of at least one implant with an expected peri-implant bone dehiscence = 2 mm of apico-coronal dimension in the maxilla or mandible (excl. molars) -primary implant stability assessed at implant placement -no need of soft tissue grafting after implant placement -tooth extraction performed = 4 months in advance -possibly performed soft tissue grafting = 2 months in advance -Presence of one adjacent tooth at the implant site; -Presence of antagonist; -Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%); -Capability to comply with the study procedures -Signed Informed Consent Form
Exclusion criteria
Exclusion criteria: -Ridge preservation procedure after tooth extraction performed -Pregnant or lactating women; -Known or suspected non-compliance, drug or alcohol abuse -Smokers (>10 cigarettes/day including e-cigarettes) -Currently taking drugs that influence bone metabolism -Use of bisphosphonates in the last 4 years -Systemic or local conditions presenting a contraindication to implant treatment -History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of horizontal bone thickness at the level of the implant shoulder of the augmented region between baseline (implant placement) and 6 months visit, measured by CBCT | — |
Secondary
| Measure | Time frame |
|---|---|
| -marginal bone level (implant shoulder to first bone-to-implant-contact) at baseline, 6 months, 1 year, 3 and 5 years, by radiographs - Implant survival at 6 months, 1 year, 3 and 5 years by visual observation - horizontal bone thickness at the level of the implant shoulder of the augmented area at 6 months, 1 year, 3 and 5 years by CBCT - vertical defect fill at implant placement, at 6 months and at 5 years by radiographs - soft tissue volume at the area of interest at implant placement, at 6 months, 1 years, 3 and 5 years by volumetric analysis of the digital impressions - PD, REC and KT, PI, BOP, MML at Baseline, 6 months, 1 year, 3 and 5 years) by probing - PES: evaluator rating at final reconstruction, 1 year, 3 and 5 years -Patient reported outcomes (OHIP questionnaire, general rating of outcome) at 6 months, final reconstruction, 1 year,3 and 5 years -Prosthetic outcomes by USPHS | — |
Countries
Spain, Switzerland
Contacts
Public ContactRonald Jung
Clinic of Reconstructive Dentistry Center of Dental Medicine University of Zürich
Outcome results
None listed