tandheelkundige behandeling edentulism missing teeth
Conditions
Interventions
On1 concept NobelAcitve impant
Nobel Active
Sponsors
Nobel Biocare services AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: The subject is at least 18 years of age (or age of consent) and has passed cessation of growth. * Obtained informed consent from the subject. * The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures). * The subject shall be healthy and compliant with good oral hygiene. * Full-mouth bleeding score (FMBS) lower than 25% [10]. * Full-mouth plaque score (FMPI) lower than 20% [11]. * Suitable for implant treatment in the posterior, pre-molar and canine area in the mandible or maxilla. * The subject shall have a favorable and stable occlusal relationship. * In need of one or multiple single tooth replacements or 3-unit bridges. * Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction). * The implant sites are free from infection and extraction remnants. * The subject is suitable for a 1-stage surgical procedure. * Sufficient amount of buccal and lingual keratinized mucosa. * The subject has a sufficient amount of bone for placing NobelActive implants with a length of at least 8 mm. * Primary implant stability as assessed by manual hand testing.
Exclusion criteria
Exclusion criteria: * The subject is not able to give her/his informed consent of participating. * Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure. * Reason to believe that the treatment might have a negative effect on the subject*s overall situation (psychiatric problems), as noted in subject records or in subject history. * Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area. * Infections in the planned implantation site or adjacent tissue. * Acute, untreated periodontitis in the planned implantation site or adjacent tissue. * Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.). * Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor*s recommendations regarding treatment, food and alcohol intake or A1c level above 8%. * Alcohol or drug abuse as noted in subject records or in subject history. * Smoking of >10 cigarettes/day. * Fresh extraction sites (up to 6 weeks). * Severe bruxism or other destructive habits. * Pregnant or lactating women at the time of implant insertion. * Previous bone augmentation (lateral and/or vertical). * Soft tissue augmentation less than 2 months before implant placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective The primary objective of this clinical investigation is to evaluate the change in marginal bone levels (DMBL) of the On1 Concept from prosthetic delivery up to 1 year after prosthetic delivery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Objective The secondary objectives of this clinical investigation are: * To evaluate the soft tissue levels at 2 weeks after implant insertion, prosthetic delivery and 1 year after implant prosthetic delivery. * To demonstrate the component survival and success by clinical measurement for the study period of 1 year. * To determine the patient*s pain perception after throughout the study period of 1 year. * To determine pre- and postoperatively the impact of the On1 Concept on the patient*s oral health related quality of life. * To demonstrate the patient*s satisfaction, post prosthetic delivery with function and esthetics. * To demonstrate the ease of use and the clinician*s confidence in the On1 Concept * To record complications | — |
Countries
The Netherlands
Outcome results
None listed