1-year clinical investigation on the On1 Concept
- Conditions
- tandheelkundige behandelingedentulismmissing teeth
- Registration Number
- NL-OMON45511
- Lead Sponsor
- obel Biocare services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 17
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.
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective<br /><br>The primary objective of this clinical investigation is to evaluate the change<br /><br>in marginal bone levels (DMBL) of the On1 Concept from prosthetic delivery up<br /><br>to 1 year after prosthetic delivery.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objective<br /><br>The secondary objectives of this clinical investigation are:<br /><br>* To evaluate the soft tissue levels at 2 weeks after implant insertion,<br /><br>prosthetic delivery and 1 year after implant prosthetic delivery.<br /><br>* To demonstrate the component survival and success by clinical measurement for<br /><br>the study period of 1 year.<br /><br>* To determine the patient*s pain perception after throughout the study period<br /><br>of 1 year.<br /><br>* To determine pre- and postoperatively the impact of the On1 Concept on the<br /><br>patient*s oral health related quality of life.<br /><br>* To demonstrate the patient*s satisfaction, post prosthetic delivery with<br /><br>function and esthetics.<br /><br>* To demonstrate the ease of use and the clinician*s confidence in the On1<br /><br>Concept<br /><br>* To record complications </p><br>