Partial EdentulismNCT03283241
Zolidd One ExHex Dental Implant Compared to Uncoated One ExHex Dental Implant in Subjects With Partial Edentulism
A study testing Zolidd One ExHex and One ExHex in people with Partial Edentulism, run by Addbio AB at 3 sites in Sweden.
Trial summary
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- Zolidd One ExHex and One ExHex
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 3 sitesSweden
- Study dates
- 1 Sep 2017to 1 Oct 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Dingletandläkarna
Dingle, 45561
Praktikertjänst AB Holmgatans Tandläkarmottagning
Falun, 79171
Käk-kirurgiska Kliniken, Näl
Trollhättan, 46185
About this study
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
A randomised, multicentre, double blind, parallel group comparative investigation where subjects will be randomised to receive coated or uncoated implants
Read the 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.
- Conditions
- Partial Edentulism
- Being tested
- Zolidd One ExHex, One ExHex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zolidd One ExHexDevice
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 ExHexDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Zolidd One ExHex | Active comparator | Coated titanium implant Receives: Device: Zolidd One ExHex; Device: One ExHex |
| One ExHex | Sham comparator | Uncoated titanium implant Receives: Device: Zolidd One ExHex; Device: One ExHex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (10)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: month 24
Survival Rate for All Implants
To compare survival rate of implants up to 24 months between all coated and all uncoated implants
Measured: 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)
Measured: 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
Measured: Month 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2017
- Study start1 Sep 2017
- Primary completion30 Jul 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups ration 1;1
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Addbio AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christer Dahlin, DDS, PhD, Principal investigator, Käk kirurgiska kliniken NÄL, Trollhättan, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03283241
- Sponsor's protocol ID
- ADD-001
- Status last verified
- Jan 2022
- First submitted
- 13 Sep 2017
- Last updated
- 22 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planned at the moment
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03283241
- Acronym / sponsor ID
- ADD-001
- Conditions
- Partial Edentulism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Addbio ABIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 30 Jul 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 14 Sep 2017 (actual)
- Results
- Posted 22 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Parallel groups ration 1;1
| Arm | Type | Receives |
|---|---|---|
| Zolidd One ExHex | Active comparator | Device: Zolidd One ExHex, Device: One ExHexCoated titanium implant |
| One ExHex | Sham comparator | Device: Zolidd One ExHex, Device: One ExHexUncoated titanium implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zolidd One ExHexSubject 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. | Device | One ExHex, Zolidd One ExHex |
| One ExHexSubject 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. | Device | One ExHex, Zolidd One ExHex |
Primary outcome
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
Time frame: 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
10 secondary outcomes
To Compare Absolute ISQ (Implant Stability Quotient) Highest Values Between Coated and Uncoated Implants for the "Index Implant" at Week 8 and Week 12
Time frame: week 8 and week 12
Incidence of Post-surgery Complications and Adverse Events
Time frame: Day1 to week 12
Change in ISQ (Implant Stability Quotient) Highest Value for the "Index Implant"
Time frame: Day 1 to week 8
Change in ISQ Highest Value for All Other Implants
Time frame: week 8 and week 12
Absolute ISQ (Implant Stability Quotient) Highest Value for All Other Implants
Time frame: Week 8 and 12
Change in Marginal Bone Height for All Other Implants
Time frame: week 8 and 12
Post-surgical Complications and Other Adverse Events (AEs) for All Implants
Time frame: month 24
Survival Rate for All Implants
Time frame: 24 months
Change in Marginal Bone Height for All Implants
Time frame: Day 1, month 12 and 24
Occurrence of Signs Associated With Peri-implantitis for All Implants
Time frame: Month 12 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not planned at the moment
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christer Dahlin, DDS, PhD principal investigator
Käk kirurgiska kliniken NÄL, Trollhättan, Sweden
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zolidd One ExHex and One ExHex in people with Partial Edentulism, run by Addbio AB at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.