Bone LossCoreBoneNCT02632734
The Use of CoreBone Coral Particles vs. Cones for Preservation of Alveolar Bone
A study testing CoreBone Cone device and CoreBone 500 device in people with Bone Loss, run by The Baruch Padeh Medical Center, Poriya.
Trial summary
Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices. The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- CoreBone Cone device and CoreBone 500 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Dec 2015to Dec 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy individuals
Who cannot join
- smoking
- wound healing is disturbance
About this study
Official title: Comparison Between CoreBone Coral Particles and CoreBone Coral Cones as Graft After Extraction Sockets for Alveolar Ridge Preservation
Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices. The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction. The coral grafting devices are processed from Porites corals grown in aquariums, under controlled environment. The devices are cleansed and sterilized by gamma irradiation. The measurements during follow ups will be performed from CT x rays and measurements by caliber and models.The width and height measurements from follow up x rays and models. The study will be performed on 10 patients, that two parallel teeth are diagnosed to be extracted, in same patient.The data will be analysed for bone loss and compared to previous published studies. Also comparison between two devices will be performed.
Read the detailed description
Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices.The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction.
Methods: 10 patients adults that are diagnosed for extraction of same tooth number ,each on different side of jaw. A non traumatic extraction will be performed, on both sides, sometimes not on same date. After extraction, coral device 'CoreBone500' sterile particles will fill the extraction site. Usually 0.3cc will be used. On the other side of same jaw 'CoreBone' Cone sterile of 4-5mm width and 8-10mm height will be placed in socket. Sutures will be placed and efforts will be put in covering the opening by soft tissues. Follow up of the alveolar ridge preservation will be performed using CT at time of grafting and 6 month later. Measurements during follow ups will be performed by caliber the width and height of alveolar ridge 2 weeks, 3month and 6 month follow up. A clinical follow up of healing soft tissues after grafting and patients complaints of pain will be addressed. If any unusual complaints from patients appears the study will be terminated immediately. From our preclinical studies no adverse effects were found. The analysis of data will be statistically analysed and compared to published data. We expect that CoreBone Cones are more effective in ridge preservation.
- Conditions
- Bone Loss
- Being tested
- CoreBone Cone device, CoreBone 500 device
- Keywords
- alveolar bone preservation, coral grafting device
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoreBone Cone deviceDevice
coral derived devices in the form of Cones are placed in extraction sites for preservation of bone during 6month and more.
CoreBone 500 deviceDevice
coral derived devices in the form of particulate (CoreBone 500) are placed in extraction sites for preservation of bone. Follow up during 6month and more.
| Study group | Role | What they receive |
|---|---|---|
| CoreBone Cone device | Experimental | Experimental: CoreBone Cone device After extraction intervention will include the placement of CoreBone Cone device derived from coral that its dimensions is 4-5mm width and 8-10mm height. One cone for each extraction socket.Its advantage is that it fits well the socket site.Measurements from models taken at different times will be analysed for bone loss. Changes in width and height of alveolar bone will be studied at 3 and 6 month. We predict that CoreBone Cones are more effective than particulate device. Receives: Device: CoreBone Cone device |
| CoreBone 500 device | Experimental | After extraction intervention will include the placement of CoreBone500 device derived from coral that is particulate. 0.3-0.5cc for each extraction socket.Its advantage is that it fills well the socket site.Measurements from models taken at different times will be analysed for bone loss. Changes in width and height of alveolar bone will be studied at 3 and 6 month. Receives: Device: CoreBone 500 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone loss will be measured from dental impression models of the grafted site by caliper
The bone loss will be measured from dental impression models of the grafted site that will be taken 2 weeks,3 month,6 month after grafting,using a caliper for measurements from models.
Measured: 2 weeks, 3 month, 6 month after grafting
Secondary outcomes (1)
preferred device for socket preservation
In addition a comparison between bone loss when CoreBone500 device will be grafted and CoreBone Cone.
Measured: 2year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone LossStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Victoria yaffe gartsbein, The Baruch Padeh Medical Center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632734
- Sponsor's protocol ID
- CoreBone.CTIL
- Acronym
- CoreBone
- Status last verified
- Dec 2015
- First submitted
- 8 Nov 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between CoreBone Coral Particles and CoreBone Coral Cones as Graft After Extraction Sockets for Alveolar Ridge Preservation
- ClinicalTrials.gov ID
- NCT02632734
- Acronym / sponsor ID
- CoreBone / CoreBone.CTIL
- Conditions
- Bone Loss
- Keywords
- alveolar bone preservation, coral grafting device
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 Dec 2015 (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.
Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices. The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction. The coral grafting devices are processed from Porites corals grown in aquariums, under controlled environment. The devices are cleansed and sterilized by gamma irradiation. The measurements during follow ups will be performed from CT x rays and measurements by caliber and models.The width and height measurements from follow up x rays and models. The study will be performed on 10 patients, that two parallel teeth are diagnosed to be extracted, in same patient.The data will be analysed for bone loss and compared to previous published studies. Also comparison between two devices will be performed.
Detailed description
Normally, dentists do not graft the socket after extraction of teeth. When they do graft they use particulate graft devices.The purpose of this study is to examine whether coral particles of 300-450um in comparison to coral cones of 4-5mm wide and 8-10 mm long will preserve alveolar ridge of maxilla or mandible when grafted immediately after tooth extraction.
Methods: 10 patients adults that are diagnosed for extraction of same tooth number ,each on different side of jaw. A non traumatic extraction will be performed, on both sides, sometimes not on same date. After extraction, coral device 'CoreBone500' sterile particles will fill the extraction site. Usually 0.3cc will be used. On the other side of same jaw 'CoreBone' Cone sterile of 4-5mm width and 8-10mm height will be placed in socket. Sutures will be placed and efforts will be put in covering the opening by soft tissues. Follow up of the alveolar ridge preservation will be performed using CT at time of grafting and 6 month later. Measurements during follow ups will be performed by caliber the width and height of alveolar ridge 2 weeks, 3month and 6 month follow up. A clinical follow up of healing soft tissues after grafting and patients complaints of pain will be addressed. If any unusual complaints from patients appears the study will be terminated immediately. From our preclinical studies no adverse effects were found. The analysis of data will be statistically analysed and compared to published data. We expect that CoreBone Cones are more effective in ridge preservation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CoreBone Cone device | Experimental | Device: CoreBone Cone deviceExperimental: CoreBone Cone device After extraction intervention will include the placement of CoreBone Cone device derived from coral that its dimensions is 4-5mm width and 8-10mm height. One cone for each extraction socket.Its advantage is that it fits well the socket site.Measurements from models taken at different times will be analysed for bone loss. Changes in width and height of alveolar bone will be studied at 3 and 6 month. We predict that CoreBone Cones are more effective than particulate device. |
| CoreBone 500 device | Experimental | Device: CoreBone 500 deviceAfter extraction intervention will include the placement of CoreBone500 device derived from coral that is particulate. 0.3-0.5cc for each extraction socket.Its advantage is that it fills well the socket site.Measurements from models taken at different times will be analysed for bone loss. Changes in width and height of alveolar bone will be studied at 3 and 6 month. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy individuals
Key exclusion criteria (2 listed)
- smoking
- wound healing is disturbance
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 |
|---|---|---|
| CoreBone Cone devicecoral derived devices in the form of Cones are placed in extraction sites for preservation of bone during 6month and more. | Device | CoreBone Cone device |
| CoreBone 500 devicecoral derived devices in the form of particulate (CoreBone 500) are placed in extraction sites for preservation of bone. Follow up during 6month and more. | Device | CoreBone 500 device |
Primary outcome
Bone loss will be measured from dental impression models of the grafted site by caliper
Time frame: 2 weeks, 3 month, 6 month after grafting
The bone loss will be measured from dental impression models of the grafted site that will be taken 2 weeks,3 month,6 month after grafting,using a caliper for measurements from models.
1 secondary outcome
preferred device for socket preservation
Time frame: 2year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CoreBone Cone device and CoreBone 500 device in people with Bone Loss, run by The Baruch Padeh Medical Center, Poriya.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Bone loss will be measured from dental impression models of the grafted site by caliper (time frame: 2 weeks, 3 month, 6 month after grafting). 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 17 Dec 2015.