Dental ImplantsNCT01158664
What is the Influence of a Different Thread Pitch Design on Bone Remodelling Around Conical Southern Oral Implants?
A study testing 0.6 mm tread pitch implant and 0.1 mm tread pitch implant in people with Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- 0.6 mm tread pitch implant and 0.1 mm tread pitch implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2010to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- At least 18 years old
- Periodontally-healthy or periodontally-treated patients
- Smokers are included
- All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.
Who cannot join
- All other contra indications for implant surgery
- Guided bone regeneration or use of any substitutes
- No implantation in regenerated or augmented bone
- No immediate loading cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch
Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.
- Conditions
- Dental Implants
- Being tested
- 0.6 mm tread pitch implant, 0.1 mm tread pitch implant
- Keywords
- dental implants, different tread pitch design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.6 mm tread pitch implantDevice
0.6 mm tread pitch implant will be used
0.1 mm tread pitch implantDevice
0.1 mm tread pitch implant will be used
| Study group | Role | What they receive |
|---|---|---|
| 0.6 mm tread pitch implant | Experimental | Not described Receives: Device: 0.6 mm tread pitch implant |
| 0.1 mm tread pitch implant | Experimental | Not described Receives: Device: 0.1 mm tread pitch implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To document the outcome of bone remodeling around IBT implants
Measured: 3 years after implantation
Secondary outcomes (2)
To clinically and radiographically document the placement of both IBT implant thread types in the same patient
Measured: over 2 years
3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation
Measured: over 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hugo De Bruyn, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158664
- Sponsor's protocol ID
- 2009/649
- Status last verified
- Dec 2022
- First submitted
- 7 Jul 2010
- Last updated
- 16 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Clinical Study on Conical Southern Implants With Different Thread Pitch
- ClinicalTrials.gov ID
- NCT01158664
- Acronym / sponsor ID
- 2009/649
- Conditions
- Dental Implants
- Keywords
- dental implants, different tread pitch design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who need more than 2 dental implants will be treated by the same implant type (conical 4mm diameter IBT Southern implants) but with different thread pitch design (0,6mm en 1,0mm type). In a 3 year clinical follow up period, the bone remodelling on X-rays is registered around these implants. The role of the thread pitch design will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.6 mm tread pitch implant | Experimental | Device: 0.6 mm tread pitch implant |
| 0.1 mm tread pitch implant | Experimental | Device: 0.1 mm tread pitch implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years old
- Periodontally-healthy or periodontally-treated patients
- Smokers are included
- All types of prosthetic indications are accepted but 2 IBT type implants with different threads have to be placed in one patient on the same day. Implants can be connected or not connected in the same jaw.
Key exclusion criteria (4 listed)
- All other contra indications for implant surgery
- Guided bone regeneration or use of any substitutes
- No implantation in regenerated or augmented bone
- No immediate loading cases
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 |
|---|---|---|
| 0.6 mm tread pitch implant0.6 mm tread pitch implant will be used | Device | 0.6 mm tread pitch implant |
| 0.1 mm tread pitch implant0.1 mm tread pitch implant will be used | Device | 0.1 mm tread pitch implant |
Primary outcome
To document the outcome of bone remodeling around IBT implants
Time frame: 3 years after implantation
2 secondary outcomes
To clinically and radiographically document the placement of both IBT implant thread types in the same patient
Time frame: over 2 years
3. Outcome differences will be detected per implant center, per treated area in the mouth, per case of prosthetic rehabilitation
Time frame: over 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
- website of University Hospital Ghent, BelgiumLink provided by the sponsor.
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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.
Hugo De Bruyn, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.6 mm tread pitch implant and 0.1 mm tread pitch implant in people with Dental Implants, run by University Hospital, Ghent at 1 site in Belgium.
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 4 inclusion and 4 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 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To document the outcome of bone remodeling around IBT implants (time frame: 3 years after implantation). 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 16 Dec 2022.