Alveolar Bone LossNCT02440048
Using Boned-Apatite Cement at the Time of Extraction for Ridge Preservation at These Sites
A study testing Bond Apatite synthetic bone substitute and BioOss bovine bone substitute in people with Alveolar Bone Loss, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extration only as negative control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Bond Apatite synthetic bone substitute and BioOss bovine bone substitute
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Jun 2015to Nov 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent properly described and signed.
- Patients who need extractions of molars for dental or periodontal reasons.
- At least 18 years old.
- Need for future dental implants in the extraction areas.
Who cannot join
- No informed consent.
- Pregnant women.
- Women who breastfeed.
- Patients treated with drugs influencing metabolism of bone such as bisphosphonates.
- Heavy smokers (more than 20 cigarettes per day).
- Patients with dentures pressing on the area of extractions/bone grafts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Boned-Apatite Cement at the Time of Extractions for Ridge Preservation at These Sites
To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extration only as negative control.
Read the detailed description
Dental implants have become in the past ten years a popular and promising treatment in the rehabilitation of missing teeth. However, using implants depends on adequate alveolar bone volume. Anatomical restrictions are mostly present in posterior mandibular and maxillary regions. Alveolar bone loss usually occurs because of active periodontal disease, trauma or teeth extractions.
Teeth extractions are associated with some loss of alveolar bone in the horizontal and vertical dimensions. This loss is more pronounced when teeth are extracted because of periodontal disease. Bone grafts from different origins (autogenic, allogenic, xenogenic or alloplastic) can partly reduce the alveolar bone loss. Different ridge preservation techniques were succesfully used in clinical trials, using membranes only or as a combination of membranes and bone substitutes.
Synthetic bone grafts have been proven successfully for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years , and in orthopedics for more than 100 years . Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and doesn't alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Appatite may improve stability during bone remodeling.
This study includes patients who need extractions of incisors, canines or premolars. The extraction sockets must be mostly intact with a maximum 4 mm of one wall missing in the vertical dimension.
30 patients who need extractions from region of interest, with no extended bony defects, will be enrolled from the department of Periodontology, school of graduate dentistry, Rambam Health Care Campus
- Conditions
- Alveolar Bone Loss
- Being tested
- Bond Apatite synthetic bone substitute, BioOss bovine bone substitute
- Keywords
- extraction, Bond Apatite
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bond Apatite synthetic bone substituteDevice
Synthetic bone grafts had been successful for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years ago, and in orthopedics for more than 100 years ago. Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and does not alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Apatite may improve stability during bone remodeling.
BioOss bovine bone substituteDevice
To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with HA (®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extraction only as negative control.
| Study group | Role | What they receive |
|---|---|---|
| HA ®Bond-apatite | Experimental | 10 extraction sockets will be preserved with Bond Apatite synthetic bone substitutes as test group Receives: Device: Bond Apatite synthetic bone substitute |
| BioOss bovine bone substitute | Active comparator | 10 extraction sockets will be preserved with BioOss particles bovine bone substitute as a positive control Receives: Device: BioOss bovine bone substitute |
| extraction | No intervention | 10 extraction sockets with no use of bone substitute as negative control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
socket dimensions
Measurement of socket width (B-L aspect) in two vertical points and Distance from alveolar crest height in the middle of the socket to the marked point in the bottom of the stent.
Measured: 4 months
Secondary outcomes (1)
Complications
Complications will be documented: Infection, swelling, discomfort, pain, bone substitutes particles moving away from the tissue.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start16 Jun 2015
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, machtei, Rambam Health Care Campus
- Investigators
- prof. Eli Machtei, DMD, Principal investigator, Department of periodontology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440048
- Sponsor's protocol ID
- 0092-15-RMB CTIL
- Other IDs
- prof. Eli machtei
- Status last verified
- Apr 2018
- First submitted
- 3 May 2015
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Boned-Apatite Cement at the Time of Extractions for Ridge Preservation at These Sites
- ClinicalTrials.gov ID
- NCT02440048
- Acronym / sponsor ID
- 0092-15-RMB CTIL
- Conditions
- Alveolar Bone Loss
- Keywords
- extraction, Bond Apatite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Study start
- 16 Jun 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 12 May 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.
To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with hydroxyapatite(®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extration only as negative control.
Detailed description
Dental implants have become in the past ten years a popular and promising treatment in the rehabilitation of missing teeth. However, using implants depends on adequate alveolar bone volume. Anatomical restrictions are mostly present in posterior mandibular and maxillary regions. Alveolar bone loss usually occurs because of active periodontal disease, trauma or teeth extractions.
Teeth extractions are associated with some loss of alveolar bone in the horizontal and vertical dimensions. This loss is more pronounced when teeth are extracted because of periodontal disease. Bone grafts from different origins (autogenic, allogenic, xenogenic or alloplastic) can partly reduce the alveolar bone loss. Different ridge preservation techniques were succesfully used in clinical trials, using membranes only or as a combination of membranes and bone substitutes.
Synthetic bone grafts have been proven successfully for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years , and in orthopedics for more than 100 years . Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and doesn't alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Appatite may improve stability during bone remodeling.
This study includes patients who need extractions of incisors, canines or premolars. The extraction sockets must be mostly intact with a maximum 4 mm of one wall missing in the vertical dimension.
30 patients who need extractions from region of interest, with no extended bony defects, will be enrolled from the department of Periodontology, school of graduate dentistry, Rambam Health Care Campus
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HA ®Bond-apatite | Experimental | Device: Bond Apatite synthetic bone substitute10 extraction sockets will be preserved with Bond Apatite synthetic bone substitutes as test group |
| BioOss bovine bone substitute | Active comparator | Device: BioOss bovine bone substitute10 extraction sockets will be preserved with BioOss particles bovine bone substitute as a positive control |
| extraction | No intervention | –10 extraction sockets with no use of bone substitute as negative control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent properly described and signed.
- Patients who need extractions of molars for dental or periodontal reasons.
- At least 18 years old.
- Need for future dental implants in the extraction areas.
Key exclusion criteria (6 listed)
- No informed consent.
- Pregnant women.
- Women who breastfeed.
- Patients treated with drugs influencing metabolism of bone such as bisphosphonates.
- Heavy smokers (more than 20 cigarettes per day).
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 |
|---|---|---|
| Bond Apatite synthetic bone substituteSynthetic bone grafts had been successful for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years ago, and in orthopedics for more than 100 years ago. Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and does not alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Apatite may improve stability during bone remodeling. | Device | HA ®Bond-apatite |
| BioOss bovine bone substituteTo assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with HA (®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extraction only as negative control. | Device | BioOss bovine bone substitute |
Primary outcome
socket dimensions
Time frame: 4 months
Measurement of socket width (B-L aspect) in two vertical points and Distance from alveolar crest height in the middle of the socket to the marked point in the bottom of the stent.
1 secondary outcome
Complications
Time frame: 4 month
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 11 Apr 2018.
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Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
prof. Eli Machtei, DMD principal investigator
Department of periodontology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bond Apatite synthetic bone substitute and BioOss bovine bone substitute in people with Alveolar Bone Loss, run by Rambam Health Care Campus at 1 site in Israel.
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 6 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 11 Apr 2018. 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 Israel. 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?
socket dimensions (time frame: 4 months). 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 Apr 2018.