1-year clinical investigation on the On1 Concept

Edentulism, partial or full, is a common health issue. Treatments range from no
treatment to bridges for smaller gaps and conventional dentures for total
edentulism. An alternative is to place fixed implant restorations, which can be
used to treat indications ranging from single tooth gaps up to full edentulism.
Implants are inserted by health care professionals such as dentists, oral
surgeons or oral-maxillofacial surgeons.
In conventional procedures one-piece abutments are used. First a temporary
abutment is placed at the time of implant surgery. After healing period, the
provisional abutment is removed and a final abutment as a base for the final
restoration is placed.
With the disconnection of the provisional abutment the initial soft tissue
attachment may be compromised. However, proper soft tissue adhesion to the
dental restoration is important to maintain good soft tissue health and provide
proper bacterial barrier.
Therefore, the On1 Concept consists a two-piece abutment with a On1 Base that
is placed to the implant at time of surgery and not disconnected thereafter. A
provisional abutment can be placed onto the On1-Base and easily be exchanged
when the final abutment is placed. For this reasons the On1 Concept keeps the
initial soft tissue attachment intact and allows for good soft tissue health
and bacterial barrier.

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 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

This will be a 1-year, open, prospective, clinical multi-center investigation
on the On1 Concept and NobelActive implants. A total of 68 patients in need for
single tooth replacement or 3-unit restoration in the canine-, premolar- and
molar area of the maxilla or mandible will be treated in four study centers and
followed up to 1 year after prosthetic delivery.
The NobelActive implant(s) will be placed and the On1 Base will be screwed onto
the implant. Thereafter, an On1 Healing Cap will be attached onto the On1 Base
in order to protect the On1 Base connection during the healing phase. Two weeks
after implant surgery, the patient will be recalled to take a digital
impression with the use of an intra-oral scanner. After 10 weeks of healing the
final prosthetic will be delivered and loaded (early loading protocol).
Subjects will be consecutively included provided they meet all of the inclusion
criteria and none of the exclusion criteria. The follow-up period for all
included subject will be 1 year calculated from final prosthetic delivery.
Overall, all patients will attend 6 follow-up visits including implant
insertion. At five of these visits radiographs will be taken: implant
insertion, final prosthetic delivery, 6- and 12 months follow-up visits.
Possible dropouts and withdrawals, as well as possible adverse events, will be
carefully monitored during the entire investigation period.

On1 concept NobelAcitve impant

no study specific risk.