Bone GainPhase 4NCT02227719
Customized Titanium Membrane for Growing Jaw Bone Horizontally
A Phase 4 study testing CTI and Collagen membrane in people with Bone Gain, run by University of Michigan at 1 site in United States.
Trial summary
A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bone Gain
- What is being tested?
- CTI and Collagen membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Jun 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age >18
- Overall good, stable health
- A single missing mandibular 1st molar for at least 3 months
Who cannot join
- Any medical conditions that may contradict implant and bone surgery or influence the outcome (detailed criteria in case report form)
- Pregnancy or lactating mothers
- Current heavy smokers (>10 cigarettes/day) or previous heavy smokers who have quit less than one year
- Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria in case report form)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement
A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.
- Conditions
- Bone Gain
- Being tested
- CTI, Collagen membrane
- Keywords
- after augmentation, procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTIDevice
CTI is the titanium mesh
Collagen membraneDevice
| Study group | Role | What they receive |
|---|---|---|
| Test: CTI | Experimental | CTI is titanium mesh Receives: Device: CTI |
| Control: Collagen membrane | Active comparator | Collagen membrane is used for ridge augmentation Receives: Device: Collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
linear bone gain
Measured: 4 months after surgery
Secondary outcomes (1)
implant marginal bone level
Measured: 18 months after baseline surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startSep 2015
- Primary completionJan 2016
- Study completionJun 2016
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone GainStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hsun-Liang Chan, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02227719
- Sponsor's protocol ID
- HUM00077102
- Status last verified
- Dec 2023
- First submitted
- 26 Aug 2014
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Customized Titanium Membrane for Horizontal Ridge Augmentation With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT02227719
- Acronym / sponsor ID
- HUM00077102
- Conditions
- Bone Gain
- Keywords
- after augmentation, procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 28 Aug 2014 (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.
A single center, randomized, controlled, parallel-arm study is planned to investigate clinical outcomes of horizontal ridge augmentation with simultaneous single implant placement, using the newly designed Ti-membrane. Twenty-four adult subjects who fulfill the inclusion criteria will be enrolled. They will be randomly placed into one of two treatment groups: the customized titanium membrane (Cti-mem) or the collagen membrane (CM) group as a control. The decision of which material to use will be made after an implant is placed. Primary closure of the surgical site will be attempted for 4 months (+/- 1 month), after which the implants will be surgically uncovered and restored. Outcome analyses will be performed until 1-year after the crown will be placed, or 18 months (- 1 or +4 months) from the implant surgery. Clinical and radiographic parameters will be compared between the two experimental groups. The primary outcome is linear increase of horizontal ridge width from direct measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test: CTI | Experimental | Device: CTICTI is titanium mesh |
| Control: Collagen membrane | Active comparator | Device: Collagen membraneCollagen membrane is used for ridge augmentation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female, age >18
- Overall good, stable health
- A single missing mandibular 1st molar for at least 3 months
Key exclusion criteria (4 listed)
- Any medical conditions that may contradict implant and bone surgery or influence the outcome (detailed criteria in case report form)
- Pregnancy or lactating mothers
- Current heavy smokers (>10 cigarettes/day) or previous heavy smokers who have quit less than one year
- Unstable or unsuitable oral conditions for implant and bone surgery (detailed criteria in case report form)
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 |
|---|---|---|
| CTICTI is the titanium mesh | Device | Test: CTI |
| Collagen membrane | Device | Control: Collagen membrane |
Primary outcome
linear bone gain
Time frame: 4 months after surgery
1 secondary outcome
implant marginal bone level
Time frame: 18 months after baseline surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing CTI and Collagen membrane in people with Bone Gain, run by University of Michigan at 1 site in United States.
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 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: withdrawn, as of the sponsor's last update on 11 Dec 2023. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
linear bone gain (time frame: 4 months after surgery). 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 11 Dec 2023.