(Partially) edentulous mandible or maxilla bone defects bone regeneration
Conditions
Interventions
None listed
Sponsors
Academisch Centrum Tandheelkunde Amsterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: 1: Each patient will be at least 18 years of age and able to understand and sign an informed consent. 2: All patients will be either completely edentulous or partially edentulous (single-tooth gap or an extended edentulous space). 3: All sites require to have a healing period of a minimum of 4 months subsequent to tooth extraction and capable of receiving at least a 10mm length implant (adequate bone height) without bone augmentation at the time of implant placement.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: Local exclusion criteria: Local exclusion factors include: 1: Untreated Periodontitis 2: The presence of osseous lesions, and/or unresolved extraction wounds. 3: Inadequate bone at the time of surgery resulting in a need for guided bone regeneration. 4: Severe bruxism or clenching habits. 5: Lack of motivation or compliance. 6: History of local irradiation therapy;Systemic exclusion criteria: Systemic exclusion criteria included: 1: Bleeding disorders 2: Radiation and/or chemotherapy 3: History of renal failure 4: Bone or endocrine disorders 5: Physical handicaps capable of interfering with oral hygiene maintenance. 6: Moderate and heavy smokers (>10 cigarettes per day) or chewing tobacco. 7: Routine use of steroids 8: Leukocyte dysfunction Secondary Exclusion Criteria: At the time of implant placement and abutment connection, if any of the following criteria are met, a protocol deviation form should be completed and the subject should be followed for the duration of the study:;1: Subjects who require GBR treatment at implant surgery;2: Insufficient bone or any other bone abnormality that would contraindicate placement;3: The treatment required by this protocol is found to be inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of the present study is to explore feasibility and efficacy of collecting autogenous bone attached to the drill flukes with and without irrigation during implant site preparation. The primary objective of the present study is to compare the amount, viability, nature and osteogenic potential of bone autograft collected with two different approaches: a) bone chips collected from the Camlog® drill flukes with aqueous irrigation following a standard protocol; b) bone chips collected from the Camlog® drill flukes without aqueous irrigation following a modified slow speed drilling (speed | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives of this randomised clinical trial is to report the clinical outcome after one year of implant placement in terms of change of crestal bone level between surgery and 12 month post surgery and Survival and success of implant treatment. | — |
Countries
Netherlands
Outcome results
None listed