An interventional study of Zolidd One ExHex and One ExHex in Partial Edentulism, sponsored by Addbio AB. Completed at 3 sites in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-22.
Sponsored by Addbio AB · Not applicable, Interventional, and Treatment
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.
Exclusion Criteria:
Coated titanium implant
Device: Zolidd One ExHex · Device: One ExHex
Uncoated titanium implant
Device: Zolidd One ExHex · Device: 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.
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.
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
Time frame: 12 weeks
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: month 24
Survival Rate for All Implants
To compare survival rate of implants up to 24 months between all coated and all uncoated implants
Time frame: 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)
Time frame: 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
Time frame: Month 12 and 24
Sixty two patient started the study
| Milestone | Zolidd One ExHex | One ExHex |
|---|---|---|
| Started | 32 | 30 |
| Completed 12 weeks | 29 | 29 |
| Completed | 28 | 27 |
| Not completed | 4 | 3 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Subject relocated to finland | 0 | 1 |
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
| ISQ (Implant Stability Quotient) score | Zolidd One ExHex | One ExHex |
|---|---|---|
| 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 | 7.47 ± 25.71 | 2.83 ± 16.71 |
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
| ISQ Score | Zolidd One ExHex | One ExHex |
|---|---|---|
| week 8 | 83 | 85 |
| week 12 | 84 | 85 |
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
| Number of events reported | Zolidd One ExHex | One ExHex |
|---|---|---|
| Incidence of Post-surgery Complications and Adverse Events | 5 | 4 |
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
| ISQ Score | Zolidd One ExHex | One ExHex |
|---|---|---|
| Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant" | 4.34 ± 10.83 | 1.38 ± 8.86 |
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
| ISQ Score | Zolidd One ExHex | One ExHex |
|---|---|---|
| week 8 | 9.0 ± 21.6 | 5.1 ± 20.1 |
| week 12 | 7.1 ± 22.2 | 3.7 ± 20.4 |
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
| ISQ Score | Zolidd One ExHex | One ExHex |
|---|---|---|
| week 8 | 83 | 85 |
| week 12 | 84 | 85 |
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)
| mm(milimeter) | Zolidd One ExHex | One ExHex |
|---|---|---|
| Week 8 Mesial | 0.3 ± 0.7 | 0.2 ± 0.5 |
| Week 8 Distal | 0.4 ± 0.8 | 0.2 ± 0.4 |
| Week 12 Mesial | 0.5 ± 0.5 | 0.4 ± 0.7 |
| Week 12 Distal | 0.6 ± 1.0 | 0.4 ± 0.6 |
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
| Number of events reported | Zolidd One ExHex | One ExHex |
|---|---|---|
| Post-surgical Complications and Other Adverse Events (AEs) for All Implants | 4 | 1 |
To compare survival rate of implants up to 24 months between all coated and all uncoated implants
| Number of implant loss | Zolidd One ExHex | One ExHex |
|---|---|---|
| Survival Rate for All Implants | 0.930 (0.824 to 0.973) | 0.939 (0.822 to 0.980) |
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)
| mm(millimeter) | Zolidd One ExHex | One ExHex |
|---|---|---|
| Week 12 Mesial | 0.5 ± 0.8 | 0.3 ± 0.6 |
| Week 12 Distal | 0.5 ± 0.9 | 0.3 ± 0.6 |
| Month 24 Mesial | 0.5 ± 1.0 | 0.5 ± 1.0 |
| Month 24 Distal | 0.5 ± 1.0 | 0.5 ± 1.0 |
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
| number of participants redness/swollen | Zolidd One ExHex | One ExHex |
|---|---|---|
| 12 month | 0 | 0 |
| 24 month | 0 | 0 |
Collected over The adverse events were collected from visit 1 to 24 month. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Zolidd One ExHex | 0/32 (0%) | 1/32 (3.1%) | 7/32 (21.9%) |
| One ExHex | 0/30 (0%) | 1/30 (3.3%) | 5/30 (16.7%) |
| Event | Zolidd One ExHex | One ExHex |
|---|---|---|
| Stress fractureInjury, poisoning and procedural complications | 0/32 | 1/30 |
| Bipolar disorderPsychiatric disorders | 1/32 | 0/30 |
| Event | Zolidd One ExHex | One ExHex |
|---|---|---|
| Device FailureProduct Issues | 7/32 | 4/30 |
| Back panMusculoskeletal and connective tissue disorders | 0/32 | 1/30 |
ITT population Zolidd One exHex 32 One ExHex 30
| Age, Continuous(years) | Zolidd One ExHex | One ExHex | Total |
|---|---|---|---|
| Mean | 56.4 ± 14.0 | 60.7 ± 12.4 | 58.5 ± 13.3 |
| Sex: Female, Male(Participants) | Zolidd One ExHex | One ExHex | Total |
|---|---|---|---|
| Female | 16 | 15 | 31 |
| Male | 16 | 15 | 31 |
| Race and Ethnicity Not Collected(Participants) | Zolidd One ExHex | One ExHex | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Zolidd One ExHex | One ExHex | Total |
|---|---|---|---|
| Sweden | 32 | 30 | 62 |
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