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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Tapered dental implant developed by Dentsply Sirona
University of Iowa
Iowa City, Iowa, United States
Catholic University of Leuven
Leuven, Belgium
Dental practice Dr Mischa Krebs
Alzey, Germany
Studio Toia
Busto Arsizio, Italy
Dr.F.L.Guljé, De Mondhoek
Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.
Time frame: One year post permanent restoration (anticipated average 3 months after implant placement).
Implant survival, i.e. number of implants in place counted clinically, 2, 3, 4 and 5 years after permanent restoration.
Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.
Time frame: 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.
Implant stability will be evaluated through ISQ value using Resonance Frequency Analysis (RFA). The stability is presented as an ISQ value. The higher the ISQ value the higher the stability. Recorded as a numeric value (1-100).
Time frame: From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).
Maximum insertion torque value for each implant at implant placement.
Maximum insertion torque value (ITV), based on ITV curve, measured in Ncm.
Time frame: At date of implant placement (anticipated average 1 month after inclusion).
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Apeldoorn, Netherlands
Final insertion torque value for each implant at implant placement.
Final insertion torque value (ITV), based on ITV curve, measured in Ncm.
Time frame: At date of implant placement (anticipated average 1 month after inclusion).
Investigator questionnaire for each investigational medical device after implant placement.
Numerical scale 1-10, where 1 = totally disagree with the statement, and 10 = totally agree with the statement. Statements to be evaluated by the surgeon: "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy", "The implant has a good primary stability", "The drilling protocol is easy to use", "The implant has efficient cutting properties". Each statement will be evaluated separately.
Time frame: Immediately after implant placement (anticipated average 1 month after inclusion).
Implant success, i.e., number of implants documented as successful at 1, 2, 3 and 5 years after permanent restoration.
Successful implants counted, i.e. 'Yes' or 'No'. An implant will be considered successful if all of the following criteria are fulfilled: 1. Implant in place. 2. Lack of evidence of peri-implant radiolucency in X-ray. 3. Less than 1mm vertical bone loss during first year after loading with permanent restoration and 0,2mm annually thereafter. 4. Absence of persistent and/or irreversible signs and symptoms such as pain, infections, neuropathies, paresthesia, or violation of the mandibular canal.
Time frame: 1, 2, 3 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.
MBL changes determined from radiographs, expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. The average will be calculated and compared for each evaluation period.
Time frame: At permanent restoration (anticipated average 3 months after implant placement) and 1, 2, 3 and 5 years post permanent restoration.
Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
Probing Pocket Depth (PPD) measured as the distance from the mucosal margin to the bottom of the probe-able pocket in mm.
Time frame: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
Presence of bleeding on probing (BoP), at permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
Bleeding on Probing (BoP) recorded as presence or absence of bleeding when probing to the bottom of the pocket.
Time frame: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
Presence of plaque at 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.
Plaque recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site.
Time frame: 6 months, 1, 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
Time frame: Up to 5 years after permanent restoration (anticipated average 3 months after implant placement).