Partial Edentulism Clinical Trial
Official title:
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
Verified date | January 2022 |
Source | Addbio AB |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
Status | Completed |
Enrollment | 62 |
Est. completion date | October 1, 2020 |
Est. primary completion date | July 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Sweden | Dingletandläkarna | Dingle | |
Sweden | Praktikertjänst AB Holmgatans Tandläkarmottagning | Falun | |
Sweden | Käk-kirurgiska Kliniken, Näl | Trollhättan |
Lead Sponsor | Collaborator |
---|---|
Addbio AB |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Survival Rate for All Implants | To compare survival rate of implants up to 24 months between all coated and all uncoated implants | 24 months | |
Secondary | 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 | |
Secondary | 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 |
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