Clinical trial NCT05315414: Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Jaw, Edentulous, Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2022-04-07
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.


Eligibility criteria: Inclusion Criteria:

* Adult aged 18-75 years.
* Willing and able to sign and date the informed consent form.
* In need of an implant in position 16 to 26 or 36 to 46, and each subject can only receive one implant.
* Deemed by the investigator as likely to present with an initially stable implant situation.
* 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.
* 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:

* Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
* Unlikely to be able to comply with clinical investigation procedures according to investigator's judgement.
* Unable or unwilling to return for follow-up visits for a period of 5 years.
* Known allergy or hypersensitivity to titanium and/or stainless steel.
* Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease.
* Uncontrolled para-functional habits, e.g. bruxism.
* 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).
* Systemic or local disease or condition that would compromise post-operative healing and/ or osseointegration.
* 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.
* 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.
* 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.
* Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local requirements).
* Previous enrolment in the present clinical investigation.
* Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona staff and the clinical investigation site).
* 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.

Primary outcomes:
measure: Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
timeFrame: One year post permanent restoration (anticipated average 3 months after implant placement).
Secondary outcomes:
measure: Implant survival, i.e. number of implants in place counted clinically, 2, 3, 4 and 5 years after permanent restoration.
timeFrame: 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
measure: Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.
timeFrame: From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).
measure: Maximum insertion torque value for each implant at implant placement.
timeFrame: At date of implant placement (anticipated average 1 month after inclusion).
measure: Final insertion torque value for each implant at implant placement.
timeFrame: At date of implant placement (anticipated average 1 month after inclusion).
measure: Investigator questionnaire for each investigational medical device after implant placement.
timeFrame: Immediately after implant placement (anticipated average 1 month after inclusion).
measure: Implant success, i.e., number of implants documented as successful at 1, 2, 3 and 5 years after permanent restoration.
timeFrame: 1, 2, 3 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
measure: Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.
timeFrame: At permanent restoration (anticipated average 3 months after implant placement) and 1, 2, 3 and 5 years post permanent restoration.
measure: Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
timeFrame: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
measure: Presence of bleeding on probing (BoP), at permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
timeFrame: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
measure: Presence of plaque at 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
timeFrame: 6 months, 1, 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
measure: Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
timeFrame: Up to 5 years after permanent restoration (anticipated average 3 months after implant placement).
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Leuven
country: Belgium
facility: Catholic University of Leuven
city: Alzey
country: Germany
facility: Dental practice Dr Mischa Krebs
city: Busto Arsizio
country: Italy
facility: Studio Toia
city: Apeldoorn
country: Netherlands
facility: Dr.F.L.Guljé, De Mondhoek
Study officials:
affiliation: KU Leuven
name: Andy Temmerman, Prof.
role: PRINCIPAL_INVESTIGATOR
References: