Partial Edentulism
Conditions
Brief summary
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
Detailed description
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.
Interventions
DEVICEZolidd One ExHex
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.
DEVICEOne ExHex
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.
Sponsors
Addbio AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
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.
Intervention model description
Parallel groups ration 1;1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 12 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Post-surgery Complications and Adverse Events | Day1 to week 12 | 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 |
| Change in ISQ (Implant Stability Quotient) Highest Value for the Index Implant | Day 1 to week 8 | 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 |
| Change in ISQ Highest Value for All Other Implants | week 8 and week 12 | 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 |
| Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants | Week 8 and 12 | 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 |
| To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the Index Implant at Week 8 and Week 12 | 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 |
| Post-surgical Complications and Other Adverse Events (AEs) for All Implants | month 24 | 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 |
| Survival Rate for All Implants | 24 months | To compare survival rate of implants up to 24 months between all coated and all uncoated implants |
| Change in Marginal Bone Height for All Implants | Day 1, month 12 and 24 | 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) |
| Occurrence of Signs Associated With Peri-implantitis for All Implants | Month 12 and 24 | 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 |
| Change in Marginal Bone Height for All Other Implants | week 8 and 12 | 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) |
Countries
Sweden
Participant flow
Recruitment details
Sixty two patient started the study
Participants by arm
| Arm | Count |
|---|---|
| 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 implantand 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 implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. | 32 |
| 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 implantand 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 implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24. | 30 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 1 |
| Overall Study | Subject relocated to Finland | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | One ExHex | Total | Zolidd One ExHex |
|---|---|---|---|
| Age, Continuous | 60.7 years STANDARD_DEVIATION 12.4 | 58.5 years STANDARD_DEVIATION 13.3 | 56.4 years STANDARD_DEVIATION 14 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Sweden | 30 participants | 62 participants | 32 participants |
| Sex: Female, Male Female | 15 Participants | 31 Participants | 16 Participants |
| Sex: Female, Male Male | 15 Participants | 31 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 30 |
| other Total, other adverse events | 7 / 32 | 5 / 30 |
| serious Total, serious adverse events | 1 / 32 | 1 / 30 |
Outcome results
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
Time frame: 12 weeks
Population: At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zolidd 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 ISQ (Implant Stability Quotient) score | Standard Deviation 25.71 |
| 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 | 2.83 ISQ (Implant Stability Quotient) score | Standard Deviation 16.71 |
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
Time frame: Week 8 and 12
Population: At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zolidd One ExHex | Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants | week 8 | 83 ISQ Score |
| Zolidd One ExHex | Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants | week 12 | 84 ISQ Score |
| One ExHex | Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants | week 8 | 85 ISQ Score |
| One ExHex | Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants | week 12 | 85 ISQ Score |
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
Time frame: week 8 and week 12
Population: At 8 and 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zolidd One ExHex | Change in ISQ Highest Value for All Other Implants | week 8 | 9.0 ISQ Score | Standard Deviation 21.6 |
| Zolidd One ExHex | Change in ISQ Highest Value for All Other Implants | week 12 | 7.1 ISQ Score | Standard Deviation 22.2 |
| One ExHex | Change in ISQ Highest Value for All Other Implants | week 8 | 5.1 ISQ Score | Standard Deviation 20.1 |
| One ExHex | Change in ISQ Highest Value for All Other Implants | week 12 | 3.7 ISQ Score | Standard Deviation 20.4 |
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
Time frame: Day 1 to week 8
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Zolidd One ExHex | Change in ISQ (Implant Stability Quotient) Highest Value for the Index Implant | 4.34 ISQ Score | Standard Deviation 10.83 |
| One ExHex | Change in ISQ (Implant Stability Quotient) Highest Value for the Index Implant | 1.38 ISQ Score | Standard Deviation 8.86 |
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)
Time frame: Day 1, month 12 and 24
Population: 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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zolidd One ExHex | Change in Marginal Bone Height for All Implants | Week 12 Mesial | 0.5 mm(millimeter) | Standard Deviation 0.8 |
| Zolidd One ExHex | Change in Marginal Bone Height for All Implants | Week 12 Distal | 0.5 mm(millimeter) | Standard Deviation 0.9 |
| Zolidd One ExHex | Change in Marginal Bone Height for All Implants | Month 24 Mesial | 0.5 mm(millimeter) | Standard Deviation 1 |
| Zolidd One ExHex | Change in Marginal Bone Height for All Implants | Month 24 Distal | 0.5 mm(millimeter) | Standard Deviation 1 |
| One ExHex | Change in Marginal Bone Height for All Implants | Month 24 Distal | 0.5 mm(millimeter) | Standard Deviation 1 |
| One ExHex | Change in Marginal Bone Height for All Implants | Week 12 Mesial | 0.3 mm(millimeter) | Standard Deviation 0.6 |
| One ExHex | Change in Marginal Bone Height for All Implants | Month 24 Mesial | 0.5 mm(millimeter) | Standard Deviation 1 |
| One ExHex | Change in Marginal Bone Height for All Implants | Week 12 Distal | 0.3 mm(millimeter) | Standard Deviation 0.6 |
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)
Time frame: week 8 and 12
Population: At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Zolidd One ExHex | Change in Marginal Bone Height for All Other Implants | Week 8 Mesial | 0.3 mm(milimeter) | Standard Deviation 0.7 |
| Zolidd One ExHex | Change in Marginal Bone Height for All Other Implants | Week 8 Distal | 0.4 mm(milimeter) | Standard Deviation 0.8 |
| Zolidd One ExHex | Change in Marginal Bone Height for All Other Implants | Week 12 Mesial | 0.5 mm(milimeter) | Standard Deviation 0.5 |
| Zolidd One ExHex | Change in Marginal Bone Height for All Other Implants | Week 12 Distal | 0.6 mm(milimeter) | Standard Deviation 1 |
| One ExHex | Change in Marginal Bone Height for All Other Implants | Week 12 Distal | 0.4 mm(milimeter) | Standard Deviation 0.6 |
| One ExHex | Change in Marginal Bone Height for All Other Implants | Week 8 Mesial | 0.2 mm(milimeter) | Standard Deviation 0.5 |
| One ExHex | Change in Marginal Bone Height for All Other Implants | Week 12 Mesial | 0.4 mm(milimeter) | Standard Deviation 0.7 |
| One ExHex | Change in Marginal Bone Height for All Other Implants | Week 8 Distal | 0.2 mm(milimeter) | Standard Deviation 0.4 |
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
Time frame: Day1 to week 12
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zolidd One ExHex | Incidence of Post-surgery Complications and Adverse Events | 5 Number of events reported |
| One ExHex | Incidence of Post-surgery Complications and Adverse Events | 4 Number of events reported |
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
Time frame: Month 12 and 24
Population: 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)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zolidd One ExHex | Occurrence of Signs Associated With Peri-implantitis for All Implants | 12 month | 0 number of participants redness/swollen |
| Zolidd One ExHex | Occurrence of Signs Associated With Peri-implantitis for All Implants | 24 month | 0 number of participants redness/swollen |
| One ExHex | Occurrence of Signs Associated With Peri-implantitis for All Implants | 12 month | 0 number of participants redness/swollen |
| One ExHex | Occurrence of Signs Associated With Peri-implantitis for All Implants | 24 month | 0 number of participants redness/swollen |
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
Time frame: month 24
Population: See adverse events, all implant loss is reported as adverse events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zolidd One ExHex | Post-surgical Complications and Other Adverse Events (AEs) for All Implants | 4 Number of events reported |
| One ExHex | Post-surgical Complications and Other Adverse Events (AEs) for All Implants | 1 Number of events reported |
Secondary
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
Population: 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)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Zolidd One ExHex | Survival Rate for All Implants | 0.930 Number of implant loss |
| One ExHex | Survival Rate for All Implants | 0.939 Number of implant loss |
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
Time frame: week 8 and week 12
Population: At 12 weeks 3 subjects have missing data in Zolidd One ExHex and 1 subject have missing data in One ExHex
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Zolidd One ExHex | To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the Index Implant at Week 8 and Week 12 | week 8 | 83 ISQ Score |
| Zolidd One ExHex | To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the Index Implant at Week 8 and Week 12 | week 12 | 84 ISQ Score |
| One ExHex | To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the Index Implant at Week 8 and Week 12 | week 8 | 85 ISQ Score |
| One ExHex | To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the Index Implant at Week 8 and Week 12 | week 12 | 85 ISQ Score |