1. Primary objectiveThe primary objective of this clinical investigation is to evaluate implant survival rate 1 year afterpermanent restoration (PR), i.e. implant in place 1 year after PR, Yes/No.2. Secondary objectivesThe secondary objectives are…
ID
Source
Brief title
Condition
- Other condition
- Bone and joint therapeutic procedures
Synonym
Health condition
herstel dentitie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of this clinical investigation is to evaluate implant
survival rate 1 year after
permanent restoration (PR), i.e. implant in place 1 year after PR, Yes/No.
Secondary outcome
The secondary objectives are to evaluate:
* Implant survival rate 2, 3, 4 and 5 years after PR.
* Implant stability at implant placement and at PR.
* Insertion Torque Value (ITV) and torque build-up at implant placement.
* The surgeon*s perception of implant stability and confidence at implant
placement.
* Maintenance of Marginal Bone Levels (MBL).
* Condition of the periimplant mucosa (bleeding on probing (BoP), probing
pocket depth
(PPD) and plaque).
* Implant success (adapted Albrektsson et al 19866).
Background summary
Tapered dental implants are well-established medical devices which are
available in a range of
different sizes pending the anatomical context at hand. There is clinical proof
for their successful
application in immediate installation, immediate loading as well as in
different bone qualities.
There are also reports on potential advantages of the tapered shape regarding
available space
at the insertion site, and also regarding reduced risk of bone fracture.
The motivation behind the development of the tapered implant design is
mimicking the natural
shape of tooth roots of non-molars as it is deemed advantageous to fit
extraction sockets and
provide increased stability and adequate stress distribution.
Based on practicing dental expert point of view, tapered implants might often
be preferred
because of their better fit in the edentulous space and the perception of
achieving a higher
primary stability as compared to cylindrical implants.
Study objective
1. Primary objective
The primary objective of this clinical investigation is to evaluate implant
survival rate 1 year after
permanent restoration (PR), i.e. implant in place 1 year after PR, Yes/No.
2. Secondary objectives
The secondary objectives are to evaluate:
* Implant survival rate 2, 3, 4 and 5 years after PR.
* Implant stability at implant placement and at PR.
* ITV and torque build-up at implant placement.
* The surgeon*s perception of implant stability and confidence at implant
placement.
* Maintenance of Marginal Bone Levels (MBL).
* Condition of the periimplant mucosa (bleeding on probing (BoP), probing
pocket depth
(PPD) and plaque).
* Implant success (adapted Albrektsson et al 19866).
Study design
The PrimeTaper clinical investigation is an open prospective, single-arm,
multicenter,
international clinical investigation with a 5-year follow-up period. The
primary objective is to
evaluate implant survival 1 year after Permanent Restoration (PR). Partially
edentulous subjects
in need of one implant in the maxilla or mandible (2nd and 3rd molars excluded)
will be included
using competitive recruitment until 137 subjects/implants are reached at 6
centers (including
20% drop-out rate to assure 109 fully evaluable subjects at 1 year after PR),
and until at least
13 subjects have received one implant in length 6.5mm (including 20% drop-out
rate to assure
10 fully evaluable subjects).
The implant can be placed in all bone qualities with a one- or two-stage
surgical protocol as per
the investigator*s preference. The timing of implant placement7 is divided into:
* Immediate implant placement
- Implant placed in a fresh extraction socket just after tooth extraction
* Immediate-delayed implant placement
- Implant placed in an extraction socket within 8 weeks after tooth extraction
* Delayed implant placement
- Implant placed at least 2 months after tooth extraction
NB! Tooth extraction made within the clinical investigation should preferably
be deemed
suitable for either immediate or immediate-delayed implant placement (i.e.
within 8 weeks).
Delayed implant placement in the PrimeTaper clinical investigation is mainly
aimed for subjects
edentulous for more than two months at time of inclusion.
Loading protocol can be chosen as per the investigator*s preference:
* Immediate loading
- Implant connected to the prosthesis within 2 days from implant placement
* Early loading
- Implant connected to the prosthesis between 3 days to 8 weeks after implant
placement
* Conventional loading
- Implant connected to the prosthesis more than 8 weeks up to 6 months after
implant
placement
For all of the above, either temporary restoration (Temp Abutment EV) or PR
(TiDesign EV) can
be chosen as per the investigator*s preference:
* Temporary restoration
- Implant connected to prosthesis held out of occlusion with the opposing arch.
* Permanent restoration
- Implant connected to prosthesis in balanced occlusion with the opposing arch.
However, the final crown (cement- or screw retained, full contour Zirconia)
must be in place no
later than 6 months after implant placement. PR will be baseline for the
follow-up visits.
Radiographic examinations will take place before surgery for treatment
planning, at implant
placement, at PR and 6 months, 1 year, 2 years, 3 years and 5 years after PR.
ITV and primary
stability (ISQ) will be recorded at implant placement and the surgeon*s
perception of the implant
installation will be collected. Analogue impression technique will be used. ISQ
will be recorded
also at PR. PPD and BoP will be recorded at PR and at all follow-up visits.
Plaque will be
recorded at all follow-up visits after PR. Implant success will be evaluated 1,
2, 3 and 5 years
after PR and safety assessments will take place throughout the clinical
investigation.
11 standard visits are planned for each subject. Depending on the treatment
chosen additional
visits may be scheduled at the discretion of the investigator.
Study burden and risks
RISKS FOR PARTICIPATING SUBJECT
LIKELIHOOD CONSEQUENCES
MITIGATION
Investigational medical device
Low N/A. There are
no N/A
additional risks or
disadvantages
foreseen with
PrimeTaper EV
implants
compared to
other implants on
the market
Radiographic exposure
Low There are
no All attempts to limit X-ray
additional
X-rays exposure will be made
taken
compared during the clinical
to normal
routine investigation, including
proper shielding.
Processing of subjects*
Low
Potential Risks related to the
personal
data
exposure of
processing of subjects*
personal
data personal data, and in
particular data concerning
health, will be mitigated by
use of pseudonymization,
whereby the personal data
.
Zwolse Binnenweg 5
Apeldoorn 7315CA
NL
Zwolse Binnenweg 5
Apeldoorn 7315CA
NL
Listed location countries
Age
Inclusion criteria
For inclusion in the clinical investigation subjects must meet all of the
following criteria:
1. Adult aged 18-75 years.
2. Willing and able to sign and date the informed consent form.
3. In need of an implant in position 16 to 26 or 36 to 46, and each subject can
only receive one
implant.
4. Deemed by the investigator as likely to present with an initially stable
implant situation.
5. A stable occlusion, i.e. an opposing natural dentition, a crown, an
implant-supported fixed or
removable prosthesis, a partial removable prosthesis or a full denture.
6. An adjacent tooth (root with natural or artificial crown) or an
implant-supported crown
mesially and distally. Exemption: If the planned implant is in the first molar
position, an
edentulous space is accepted distally.
Exclusion criteria
Exclusion criteria
All exclusion criteria apply at inclusion with a final eligibility verification
prior to implantation, but
exclusion criteria number 4 also applies during the entire clinical
investigation period.
Any of the following is regarded as a criterion for exclusion from the clinical
investigation:
1. Not willing to participate in the clinical investigation or not able to
understand the content of
the clinical investigation.
2. Unlikely to be able to comply with clinical investigation procedures
according to
investigator*s judgement.
3. Unable or unwilling to return for follow-up visits for a period of 5 years.
4. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply
Sirona.
5. Known allergy or hypersensitivity to titanium and/or stainless steel.
6. Uncontrolled pathological process in the oral cavity, e.g. untreated rampant
caries and
uncontrolled periodontal disease.
7. Uncontrolled para-functional habits, e.g. bruxism.
8. Current need of any Guided Bone Regeneration (GBR) procedure in the planned
implant
area (gap filling at immediate placement and soft tissue grafting are allowed).
9. Systemic or local disease or condition that would compromise post-operative
healing and/
or osseointegration.
10. Immunosuppression, use of corticosteroids, per-os or intravenous
bisphosphonate use, or
any other medication such as anti-resorptive therapy or monoclonal antibodies
that could
compromise post-operative healing and/or osseointegration.
11. Any other condition that would make the subject unsuitable for
participation, including but
not limited to;
* History of radiation therapy in the head and neck region.
* History of chemotherapy within 5 years prior to surgery.
* Present alcohol and/or drug abuse.
* Ongoing psychiatric illness.
* Current smoking/use of tobacco, including e-cigarettes.
12. Any ongoing disease that would make the subject unsuitable for
participation, including but
not limited to;
* Recent myocardial infarction (< 3 months*).
* Recent cerebrovascular accident (< 3 months*).
* Recent cardiac-valvular prosthesis placement (< 3 months*).
* Hemorrhagic diathesis.
* Severe liver dysfunction.
* Known or suspected current malignancy.
* Uncontrolled diabetes mellitus.
* Florid infection.
13. Pregnant or breastfeeding females. (Pregnancy tests will be performed as
per local
requirements).
14. Previous enrolment in the present clinical investigation.
15. Involvement in the planning and conduct of the clinical investigation
(applies to both
Dentsply Sirona staff and the clinical investigation site).
16. Simultaneous participation in another clinical investigation, or
participation in a clinical
investigation during the last 6 months that may interfere with the present
clinical
investigation.
* < 3 months is a strict exclusion criterion. After 3 month it is up to the
investigator to judge whether the subject is considered suitable for
participation or not.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80094.028.21 |