Evaluating the PrimeTaper EV Implant for 5 Years

Implant Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05387421
• Other study ID #: 202112263
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2022
• Est. completion date: July 2028

Study information

• Verified date: May 2022
• Source: University of Iowa
• Contact: Christopher Barwacz, DDS
• Phone: 3193843002
• Email: chris-barwacz[@]uiowa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the PrimeTaper's implant survival rate 1 year after permanent restoration (PR). After being identified as being eligible for the study (i.e., via screening and pre-planning surgical visits), subjects will have the PrimeTaper implant placed with a post-op check-up 1-2 weeks later, as well an impression visit in order to develop the permanent restoration. Furthermore, the permanent restoration will be placed no more than 6 months beyond the implant placement visit. After the permanent restoration, there will be follow-up visits at: (i) 6 months, (ii) 1 year, (iii) 2 years, (iv) 3 years, (v) 4 years, and (vi) 5 years.

Description:

The primary objective is to evaluate implant survival rate 1 year after permanent restoration (PR) (i.e., implant in place 1 year after PR, Yes/No). Secondary objectives are to evaluate: (i) implant survival rate 2, 3, 4, and 5 years after PR, (ii) implant stability at implant placement and at PR, (iii) insertion torque value and torque build-up at implant placement, (iv) the surgeon's perception of implant stability and confidence at implant placement, (v) maintenance of marginal bone levels (MBL), (vi) condition of the peri-implant mucosa (i.e., bleeding on probing (BoP), probing pocket depth (PPD), and plaque), and (vii) implant success. Furthermore, the safety objective of the investigation is to evaluate the safety of the PrimeTaper EV implant by assessing occurrence and severity of adverse events (i.e., evaluate reported Adverse Events (AEs), Device Deficiencies (DDs) and Adverse Device Effects (ADEs).

The null hypothesis is that at 1 year after PR, the implant will have survived in less than or equal to 89% of the subjects. Therefore, the study can test the alternative hypothesis that at 1 year after PR, the implant will have survived in greater than 89% of the subjects.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: July 2028
• Est. primary completion date: July 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Adult aged 18-75 years.

2. Willing and able to sign and date the informed consent form and willing to attend 11 study visits over the next 5.5 years.

3. In need of an implant in tooth position 16 to 26 (i.e., Tooth Numbers 3-14) or 36 to 46 (i.e., Tooth Numbers 19-30), 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., bite), 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 (i.e., space without a tooth) is accepted distally.

7. Site-specific Requirement: Must be fluent in speaking, reading, and comprehending English without need for a translator.

8. Site-Specific Requirement: Must be able to financially pay for ~$1300 for final crown, $15 for chlorhexidine mouthwash, and if applicable, $200 for tooth extraction and $600 for bone grafting.

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: (i) History of radiation therapy in the head and neck region, (ii) History of chemotherapy within 5 years prior to surgery, (iii) Present alcohol and/or drug abuse, (iv) Ongoing psychiatric illness, (v) 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: (i) Recent myocardial infarction (< 3 months*), (ii) Recent cerebrovascular accident (< 3 months*), (iii) Recent cardiac-valvular prosthesis placement (< 3 months*), (iv) Hemorrhagic diathesis, (v) Severe liver dysfunction, (vi) Known or suspected current malignancy, (vii) Uncontrolled diabetes mellitus, (viii) Florid infection.

13. Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local requirements).

14. Previous enrollment 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.

Related Conditions & MeSH terms

• Implant

Intervention

Device:
• PrimeTaper EV Implant
All subjects will receive the PrimeTaper EV Implant

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
University of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Implants that Survived 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	1 year after Permanent Restoration (baseline)
Secondary	Rate of Implants that Survived at 2, 3, 4 and 5 years after Permanent Restoration	Implant survival rate will be 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.	2, 3, 4, and 5 years after Permanent Restoration (baseline)
Secondary	Implant stability at implant placement and at Permanent Restoration	Implant stability will be evaluated through ISQ (primary implant stability) value using Resonance Frequency Analysis (RFA). The stability is presented as an ISQ value. The higher the ISQ value the higher the stability. Utilizing RFA involves sending magnetic pulses to SmartPegs temporarily attached to the implant. As the SmartPegs vibrates, the probe reads its resonance frequency and translates it into an ISQ value. In general, RFA measurements are used to assess the stability of the implant immediately after placement, as well as to measure the stability during healing time and follow-up. ISQ will be measured bucco-lingually and mesio-distally.; The instrument Osstell Beacon together with applicable SmartPegs will be used to measure implant stability. Recorded as a numeric value (1-100).	During Implant Placement Procedure and During Permanent Restoration (baseline)
Secondary	Insertion Torque Value at implant placement.	Insertion Torque Value (ITV) will be measured for the implant during placement.; ImplantMed Plus equal to DentsplySirona Implant 1000 (W&H, Bürmoos, Austria) will be used to measure the max and final ITV. If manual or contra- angle seating has been performed this will be recorded.	During Implant Placement Procedure
Secondary	The surgeon's perception of implant stability and confidence at implant placement.	After implant placement, the surgeon will complete the investigator questionnaire with numerical scale (1-10). The surgeon records his/her response to each statement with a number from 1 to 10, where 1 is totally disagree with the statement, and 10 is totally agree with the statement. Each statement will be evaluated separately. The questionnaire contains the following statements: "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"	Immediately After Implant Placement Procedure
Secondary	Maintenance of Marginal Bone Levels (MBL)	MBLs will be determined from the 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. Intraoral periapical radiographs will be used. To ensure reproducibility between the examinations, radiographs will be taken with parallel technique using sensor holders, if available. The profile of the marginal portion of the implant, both mesially and distally, must be clearly visible. Distances from implant reference points to the most coronal bone to implant contact on the mesial and distal aspects of the implant will be recorded.; The change in the MBL from baseline (PR) to each time point will be calculated. The average will be calculated and compared for each evaluation period. Peri-implant radiolucency will be recorded as presence or absence. The evaluating radiologist will be independent from the investigational team.	The MBL change from baseline (Permanent Restoration) compared to 1, 2, 3, and 5 years will be calculated. In addition, MBL changes may be calculated from Implant placement.
Secondary	Condition of the periimplant mucosa - bleeding on probing (BoP)	BoP will be evaluated at four surfaces around the implant (mesial, distal, buccal and lingual) by using a periodontal probe. Bleeding will be recorded as presence or absence of bleeding when probing to the bottom of the pocket. Changes over time will be analyzed.; For BoP the proportion of surfaces with presence of bleeding will be calculated and presented on an implant level for each visit. Changes over time will be analyzed.; BoP will be evaluated at four surfaces around the implant (mesial, distal, buccal and lingual), by using a periodontal probe. Bleeding will be recorded as presence or absence of bleeding when probing to the bottom of the pocket. For BoP, the proportion of surfaces with presence of bleeding will be calculated and presented on an implant level for each visit. Changes over time will be analyzed.	Permanent Restoration (baseline), 6 month follow-up, and 1, 2, 3, 4, and 5 years
Secondary	Condition of the periimplant mucosa - probing pocket depth (PPD)	PPD will be evaluated at four surfaces around the implant (mesial, distal, buccal and lingual), by using a periodontal probe. PPD will be measured as the distance from the mucosal margin to the bottom of the probe-able pocket in mm. For PPD mean values will be calculated on an implant level for each visit. Changes over time will be analyzed.; For plaque the proportion of surfaces with presence of plaque will be calculated and presented on an implant level for each visit. Changes over time will be analyzed.	Permanent Restoration (baseline), 6 month follow-up, and 1, 2, 3, 4, and 5 years
Secondary	Condition of the periimplant mucosa - plaque	Plaque will be recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site. For plaque, the proportion of surfaces with presence of plaque will be calculated and presented on an implant level for each visit. Changes over time will be analyzed.	Permanent Restoration (baseline), 6 month follow-up, and 1, 2, 3, 4, and 5 years
Secondary	Implant success (adapted Albrektsson et al 1986).	An implant will be considered successful if all of the following criteria are fulfilled: Implant in place.; Lack of evidence of peri-implant radiolucency in X-ray.; Less than 1mm vertical bone loss during first year after loading with PR and 0,2mm annually thereafter.; Absence of persistent and/or irreversible signs and symptoms such as pain, infections, neuropathies, paresthesia, or violation of the mandibular canal. Successful implants counted, i.e. 'Yes' or 'No' where 'Yes' means that the implant is considered successful 'No' means that the implant is not successful.; The evaluation of implant success will be based upon 'Yes' or 'No' answers derived from the adverse event (AE) /adverse device effect (ADE) sections of the eCRF and the MBL alteration compared with PR. In addition, peri-implant radiolucency will be registered as present or absent.	Permanent Restoration (baseline), and 1, 2, 3, 4, and 5 years