Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism

Study Overview
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Brief Summary
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A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants

Detailed Description
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The study will consist of two parts. Part I, is the main study ending when all subjects have reached visit 5. The study will be evaluated and Clinical Study Report (CSR) will be written for this part. Part II, of the study is a post-follow up study starting when the first subject has completed visit 5. There will be a separate CSR written for Study Part II. The study Part I will begin with a baseline visit, visit 1, Informed consent procedure will take place. Provided the subject will give informed consent for both Study Part I and Study Part II the screening procedure starts. Subjects will undergo all screening and baseline assessment procedures including assessments of dental status to determine number of implants needed. Subjects who meet all the inclusion criteria and none of the exclusion criteria will be given a date for implant surgery within three weeks. The required number of implants will be ordered from the Study Distributor. At the implantation day, visit 2, eligibility will be re-checked before the surgery procedures starts. The subjects who still are eligible will enter the treatment and the implantation surgery is conducted. The first follow-up visit after implantation will take place week 2 post-surgery and the last follow-up visit in Study Part I will be at week 12. Any post-surgical complications and adverse events will be collected and recorded in the eCRF. On demand, depending on the outcome of the surgery, additional visits might occur. Study Part II, the Post Follow-up Study, consist of two visits, one at month 12 and another visit at month 24 post-surgery. Post-surgical complications and adverse events from Study Part I will be followed-up if not resolved previously. Safety, survival rate and marginal bone loss will be assessed and outcome recorded in the eCRF. Additional visits might occur depending on the status of the subjects.

Official Title
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A Randomized, Multicentre, Double Blind, Parallel Study to Evaluate the Performance and Safety of the Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism

Conditions
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Partial Edentulism

Intervention / Treatment
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* Device: Zolidd One ExHex
* Device: One ExHex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects aged >18 years Subjects should be willing to take part, able to understand the information given to them, and give written consent Subject diagnosed with partial edentulism and who needs at least one dental implant in the posterior upper jaw i.e. premolars to first molar. The same subject may also need implants in the posterior mandible (premolars to first molar region) Exclusion Criteria: Suspected to be immunocompromised or are taking immunosuppressant Current participation in another clinical investigation or participation within the last 6 months Known sensitivity/allergies to any of the test materials or any of their ingredients, such as bisphosphonate, titanium or human fibrinogen Significant current or past medical history of hepatic, renal, cardiac, pulmonary, digestive, haematological, neurological, or psychiatric disease, hypercalcaemia, previous or ongoing malignancy in the head and neck region or uncontrolled diabetes type I which in the opinion of the Investigator, would compromise the safety of the subject or affect the outcome of the investigation Pregnant and lactating females or those actively seeking to become pregnant in the next 3 months Previous (last 5 years) or on-going Bisphosphonate or Denosumab treatment Significant marginal bone loss prior to implant insertion requiring bone grafting or bone graft substitute Subject with extraction(s) performed in the position of implant placement within the last 2 months Subject with need of >6 implants or a full bridge The final prosthetic construction in need of support from neighbouring teeth Known drug or alcohol abuse Subjects only needed implant(s) in the posterior mandible region

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel groups ration 1;1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Zolidd One ExHex<br>Coated titanium implant | Device: Zolidd One ExHex<br>* Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.<br>Device: One ExHex<br>* Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.<br>|
| Sham Comparator: One ExHex<br>Uncoated titanium implant | Device: Zolidd One ExHex<br>* Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.<br>Device: One ExHex<br>* Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Stability at 12 Weeks Minus Value at Baseline (Day 1) Comparing Coated and Uncoated Implants Change in Stability From Day 1(Implantation to 12 Weeks After Implantation of the Index Implant Comparing Coated and Uncoated Implants | The primary objective is to compare the mean change in stability at 12 weeks minus value at baseline (day 1)after surgery of the index implant between coated and uncoated implants. An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the Index Implant at Week 8 and Week 12 | To compare absolute ISQ (Implant Stability Quotient) highest values between coated and uncoated index implants at week 8 and week 12 after implantation An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100 1 No stability 100 stability Aim its to get close to 100 | week 8 and week 12 | 
| Incidence of Post-surgery Complications and Adverse Events | To compare safety as assessed by complications post-surgery and any other adverse event up to week 12 between all coated and all uncoated implants | Day1 to week 12 | 
| Change in ISQ (Implant Stability Quotient) Highest Value for the Index Implant | To compare change in stability from day 1 to week 8 between the coated and the uncoated index implants An ISQ (Implant Stability Quotient) probe is used to measure the stability of the implant ISQ (Implant Stability Quotient) scale is 1-100 1 No stability 100 stability The aim is to get as close to a 100 as possible | Day 1 to week 8 | 
| Change in ISQ Highest Value for All Other Implants | To compare change in stability from day 1 to week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100 1 No stability 100 stability | week 8 and week 12 | 
| Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants | To compare absolute ISQ (Implant Stability Quotient) highest value at week 8 and 12 between all other coated and all other uncoated implants An ISQ (Implant Stability Quotient) probe is used ISQ scale is 1-100 1 No stability 100 stability | Week 8 and 12 | 
| Change in Marginal Bone Height for All Other Implants | To compare change in marginal bone height between all coated and all uncoated implants from at week 8 and 12 The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter) | week 8 and 12 | 
| Post-surgical Complications and Other Adverse Events (AEs) for All Implants | To compare safety as assessed by complications post-surgery and other adverse events up to month 24 post-implantation visit between all coated and all uncoated implants | month 24 | 
| Survival Rate for All Implants | To compare survival rate of implants up to 24 months between all coated and all uncoated implants | 24 months | 
| Change in Marginal Bone Height for All Implants | To compare change in marginal bone height from day 1 to month 12 and 24 between all coated and all uncoated implants The marginal bone height is measured by x-ray and measuring the distance between the implant and bone in mm (millimeter) | Day 1, month 12 and 24 | 
| Occurrence of Signs Associated With Peri-implantitis for All Implants | To compare peri-implantitis frequency at 12 and 24 months between all coated and all uncoated implants Ocular assessment of redness and swelling this is an overall judgement of peri-implantitis | Month 12 and 24 |