An open, prospective, multicenter investigation to evaluate the clinical outcome of PrimeTaper EV implant in extraction sockets and healed ridges - A 5 year follow-up

• Conditions: herstel dentitie; missing teeth; partial edentulous; 10005944

• Registration Number: NL-OMON51681
• Lead Sponsor: Gulje Mondzorg bv

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 25

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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this clinical investigation is to evaluate implant<br /><br>survival rate 1 year after<br /><br>permanent restoration (PR), i.e. implant in place 1 year after PR, Yes/No.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objectives are to evaluate:<br /><br>* Implant survival rate 2, 3, 4 and 5 years after PR.<br /><br>* Implant stability at implant placement and at PR.<br /><br>* Insertion Torque Value (ITV) and torque build-up at implant placement.<br /><br>* The surgeon*s perception of implant stability and confidence at implant<br /><br>placement.<br /><br>* Maintenance of Marginal Bone Levels (MBL).<br /><br>* Condition of the periimplant mucosa (bleeding on probing (BoP), probing<br /><br>pocket depth<br /><br>(PPD) and plaque).<br /><br>* Implant success (adapted Albrektsson et al 19866).</p><br>