Alveolar Bone LossNCT03149172
Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
A study testing Equimatrix®, Bio-Oss® and Endobon® in people with Alveolar Bone Loss, run by Tufts University at 1 site in United States.
Trial summary
The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are… 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?
- Equimatrix®, Bio-Oss® and Endobon®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2014to 7 Dec 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-restorable single rooted tooth in anterior or premolar region
- Patient previously treatment planned for implant procedure and implant restoration.
- > 10 mm from maxillary sinus or inferior alveolar canal (IAC)
- Intact buccal bone (only minor dehiscence or fenestrations (approximately < 50% of socket depth) can be accepted
- Non-smokers.
- Patients treatment planned for extraction and ridge preservation at Tufts University School of Dental Medicine.
Who cannot join
- Poor oral hygiene (plaque index>30%).
- Systemic diseases that affect bone metabolism:
- Osteoporosis ii. Osteomalacia iii. Hyperthyroidism iv. Hyperparathyroidism v. Paget's disease
- Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):
- Severe chronic periodontitis ii. Aggressive periodontitis iii. Necrotizing ulcerative periodontitis iv. Crohn's disease v. Multiple sclerosis vi. Rheumatoid arthritis vii. Systemic lupus erythematosus
- History of radiation to the head and neck, and /or chemotherapy.
Show all 11Show fewer
- Current corticosteroid therapy.
- History of IV Bisphosphonates therapy or >3 years of oral intake.
- Infectious diseases such as HIV, tuberculosis, Hepatitis (self-report).
- Known allergy to research related materials.
- Self-reported pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
United States1 site
Tufts University School of Dental Medicine
Boston, Massachusetts, 02111
About this study
The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets.
Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.
Read the detailed description
This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®.
Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
- Conditions
- Alveolar Bone Loss
- Being tested
- Equimatrix®, Bio-Oss®, Endobon®
- 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.
Equimatrix®Device
Ridge preservation bone grafting after tooth extraction
Bio-Oss®Device
Ridge preservation bone grafting after tooth extraction
Endobon®Device
Ridge preservation bone grafting after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Equimatrix® | Experimental | Equimatrix® + Mucograft or alternatives Receives: Device: Equimatrix® |
| Bio-Oss® | Experimental | Bio-Oss® + Mucograft or alternatives Receives: Device: Bio-Oss® |
| Endobon® | Experimental | Endobon® + Mucograft or alternatives Receives: Device: Endobon® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent New Bone Formation
Histomorphometric determination of % new bone formation
Measured: 4-6 months after ridge preservation surgery
Secondary outcomes (1)
Bone Density
Measured by Micro CT Scanning
Measured: 4-6 months after ridge preservation surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start20 Oct 2014
- Primary completion7 Jun 2016
- Study completion7 Dec 2016
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 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
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Hur, Tufts University
- Investigators
- Yong Hur, DDS, DMD, MS, Principal investigator, Tufts University School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149172
- Sponsor's protocol ID
- #10963
- Status last verified
- Sep 2020
- First submitted
- 9 May 2017
- Last updated
- 25 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials
- ClinicalTrials.gov ID
- NCT03149172
- Acronym / sponsor ID
- #10963
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 20 Oct 2014 (actual)
- Primary completion
- 7 Jun 2016 (actual)
- Study completion
- 7 Dec 2016 (actual)
- First posted
- 11 May 2017 (actual)
- Results
- Posted 25 Sep 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets.
Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.
Detailed description
This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®.
Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®.
The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Equimatrix® | Experimental | Device: Equimatrix®Equimatrix® + Mucograft or alternatives |
| Bio-Oss® | Experimental | Device: Bio-Oss®Bio-Oss® + Mucograft or alternatives |
| Endobon® | Experimental | Device: Endobon®Endobon® + Mucograft or alternatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Non-restorable single rooted tooth in anterior or premolar region
- Patient previously treatment planned for implant procedure and implant restoration.
- > 10 mm from maxillary sinus or inferior alveolar canal (IAC)
- Intact buccal bone (only minor dehiscence or fenestrations (approximately < 50% of socket depth) can be accepted
- Non-smokers.
Key exclusion criteria (11 listed)
- Poor oral hygiene (plaque index>30%).
- Systemic diseases that affect bone metabolism:
- Inflammatory and autoimmune diseases of the oral cavity (severe bone loss) (self-report):
- History of radiation to the head and neck, and /or chemotherapy.
- Current corticosteroid therapy.
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 |
|---|---|---|
| Equimatrix®Ridge preservation bone grafting after tooth extraction | Device | Equimatrix® |
| Bio-Oss®Ridge preservation bone grafting after tooth extraction | Device | Bio-Oss® |
| Endobon®Ridge preservation bone grafting after tooth extraction | Device | Endobon® |
Primary outcome
Percent New Bone Formation
Time frame: 4-6 months after ridge preservation surgery
Histomorphometric determination of % new bone formation
1 secondary outcome
Bone Density
Time frame: 4-6 months after ridge preservation surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Yong Hur, DDS, DMD, MS principal investigator
Tufts University School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equimatrix®, Bio-Oss® and Endobon® in people with Alveolar Bone Loss, run by Tufts University 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 6 inclusion and 11 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 25 Sep 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Sep 2020). 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?
Percent New Bone Formation (time frame: 4-6 months after ridge preservation 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 25 Sep 2020.