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A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolidd One ExHex | Active Comparator | Coated titanium implant |
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| One ExHex | Sham Comparator | Uncoated titanium implant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolidd One ExHex | Device | Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christer Dahlin, DDS, PhD | Käk kirurgiska kliniken NÄL, Trollhättan, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dingletandläkarna | Dingle | 45561 | Sweden | |||
| Praktikertjänst AB Holmgatans Tandläkarmottagning |
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Sixty two patient started the study
| ID | Title | Description |
|---|---|---|
| FG000 | Zolidd One ExHex | Coated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
| FG001 | One ExHex | Uncoated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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ITT population Zolidd One exHex 32 One ExHex 30
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| ID | Title | Description |
|---|---|---|
| BG000 | Zolidd One ExHex | Coated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex | Posted | Mean | Standard Deviation | ISQ (Implant Stability Quotient) score | 12 weeks |
|
The adverse events were collected from visit 1 to 24 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Zolidd One ExHex | Coated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bipolar disorder | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Device Failure | Product Issues | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ulf Sewerin, CEO | AddBio AB | +46708797988 | ulf.sewerin@addbio.se |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 14, 2017 | Nov 2, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 10, 2018 | Nov 2, 2021 | SAP_001.pdf |
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Parallel groups ration 1;1
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The devices are delivered single packed and sterile to distributor. The distributor performs blinding, randomization and distribution. The labels are, after blinding of lot number, identical for both the Active and the placebo device.
| One ExHex | Device | Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
|
| 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 |
| Falun |
| 79171 |
| Sweden |
| Käk-kirurgiska Kliniken, Näl | Trollhättan | 46185 | Sweden |
| Subject relocated to Finland |
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| BG001 | One ExHex | Uncoated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | One ExHex | Uncoated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. |
|
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| 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 | At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex | Posted | Number | ISQ Score | week 8 and week 12 |
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|
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| 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 | This is the Adverse Event (AE) that has been reported and will be presented in the AE table under product issues, this is devices that failed and/or lossened At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex | Posted | Number | Number of events reported | Day1 to week 12 |
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|
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| 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 | In the Zolidd One ExHex 3 subjects have missing information. In the One ExHex group 1 subject have missing information at week 8 and 12. | Posted | Mean | Standard Deviation | ISQ Score | Day 1 to week 8 |
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| 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 | At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex | Posted | Mean | Standard Deviation | ISQ Score | week 8 and week 12 | Implants | Implants |
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| 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 | At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex | Posted | Number | ISQ Score | Week 8 and 12 | Implants | Implants |
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| 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) | At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex | Posted | Mean | Standard Deviation | mm(milimeter) | week 8 and 12 |
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| 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 | See adverse events, all implant loss is reported as adverse events | Posted | Number | Number of events reported | month 24 |
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| Secondary | Survival Rate for All Implants | To compare survival rate of implants up to 24 months between all coated and all uncoated implants | At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects) | Posted | Mean | 95% Confidence Interval | Number of implant loss | 24 months | Implants | Implants |
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| 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) | At 12 weeks 3 subjects have missing data in Zolidd One ExHex (29 subjects) and 1 subject have missing data in One ExHex (29 subjects) At 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects) | Posted | Mean | Standard Deviation | mm(millimeter) | Day 1, month 12 and 24 |
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| 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 | At 12 and 24 month 4 subjects have missing data in Zolidd One ExHex (28 subjects) and 3 subjects have missing data in One ExHex (27 subjects) | Posted | Number | number of participants redness/swollen | Month 12 and 24 |
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| 0 |
| 32 |
| 1 |
| 32 |
| 7 |
| 32 |
| EG001 | One ExHex | Uncoated titanium implant Zolidd One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. One ExHex: Subject will be treated/implanted at visit 2, one of the implants will be chosen as the "index implant"and will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. | 0 | 30 | 1 | 30 | 5 | 30 |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Non-systematic Assessment |
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| Back pan | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
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| week 12 |
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| Week 12 Mesial |
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| Week 12 Distal |
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| Week 12 Distal |
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| Month 24 Mesial |
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| Month 24 Distal |
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| 24 month |
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