Healing WoundNCT07020650
The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation
A study testing Socket preservation in people with Healing Wound, run by University of Michigan at 1 site in United States.
Trial summary
This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Healing Wound
- What is being tested?
- Socket preservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 20 and 80 years old
- Patients requiring tooth extraction (incisors, canines, and premolars) due to caries, periodontal disease, tooth fracture, or unrestorable condition.
- Extraction sockets must be infection-free with dehiscence less than 5mm.
- Patients interested in implant placement after tooth extraction.
Who cannot join
- Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)
- Hematologic disorders or blood dyscrasias.
- Active infectious diseases.
- Liver or kidney dysfunction/failure.
- Uncontrolled diabetes (i.e., HbA1c > 8).
- Undergoing active cancer treatment, including chemotherapy or radiotherapy within the last 12 months from the procedure.
Show all 12Show fewer
- Use of medications affecting bone healing (e.g., bisphosphonates, long-term anti-inflammatory medications).
- Metabolic bone diseases affecting bone healing, such as osteoporosis (self-reported).
- Pregnant or lactating women (self-reported).
- Current smokers of 10 or more cigarettes per day and former smokers who quit less than 10 years ago (self-reported).
- Poor oral hygiene.
- Presence of fenestration defects equal to or greater than 5mm.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
Official title: The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation: A Clinical, Radiographic, and Histomorphometric Study
This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material.
Read the detailed description
Bone grafts are commonly placed to increase the amount of bone right after tooth extraction and prepare the site for future dental implant placement.
45 patients requiring a tooth extraction will be recruited and randomized to receive either allograft, xenograft, or synthetic bone grafting.
- Conditions
- Healing Wound
- Being tested
- Socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationDevice
After tooth extraction, the socket will be filled with a collagen plug and bone graft.
| Study group | Role | What they receive |
|---|---|---|
| Synthetic bone | Experimental | Bone graft with carbonate apatite (Cytrans Granules) Receives: Device: Socket preservation |
| Allograft | Active comparator | Bone graft with allograft (Puros) Receives: Device: Socket preservation |
| Xenograft | Experimental | Bone graft with xenogeneic plug (BioOss) Receives: Device: Socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical alveolar ridge dimension changes
Clinically measured alveolar ridge dimension changes in mm
Measured: 4 months
Secondary outcomes (3)
Histological bone density
Histomorphometry
Measured: 4 months
Presence of bone turnover proteins
Immunohistochemistry
Measured: 4 months
Alveolar volumetric changes following tooth extraction
Digitally measured alveolar ridge changes in mm^3 using CBCT
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start5 Jun 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hom-Lay Wang, DDS, MSD, Ph D, University of Michigan
- Investigators
- Hom-Lay Wang, DDS,MSD,PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020650
- Sponsor's protocol ID
- HUM00267966
- Status last verified
- Mar 2026
- First submitted
- 5 Jun 2025
- Last updated
- 24 Mar 2026
- Results posted
- No
- 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 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Carbonate Apatite Bone Graft for Alveolar Ridge Preservation: A Clinical, Radiographic, and Histomorphometric Study
- ClinicalTrials.gov ID
- NCT07020650
- Acronym / sponsor ID
- HUM00267966
- Conditions
- Healing Wound
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Jun 2025 (actual)
- 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.
This study will examine whether the use of synthetic carbon apatite bone graft material will lead to more bone formation compared to human derived allograft and bovine derived xenograft material.
Detailed description
Bone grafts are commonly placed to increase the amount of bone right after tooth extraction and prepare the site for future dental implant placement.
45 patients requiring a tooth extraction will be recruited and randomized to receive either allograft, xenograft, or synthetic bone grafting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Synthetic bone | Experimental | Device: Socket preservationBone graft with carbonate apatite (Cytrans Granules) |
| Allograft | Active comparator | Device: Socket preservationBone graft with allograft (Puros) |
| Xenograft | Experimental | Device: Socket preservationBone graft with xenogeneic plug (BioOss) |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 20 and 80 years old
- Patients requiring tooth extraction (incisors, canines, and premolars) due to caries, periodontal disease, tooth fracture, or unrestorable condition.
- Extraction sockets must be infection-free with dehiscence less than 5mm.
- Patients interested in implant placement after tooth extraction.
Key exclusion criteria (12 listed)
- Known allergies or hypersensitivities to medications related to the study (e.g., chlorhexidine)
- Hematologic disorders or blood dyscrasias.
- Active infectious diseases.
- Liver or kidney dysfunction/failure.
- Uncontrolled diabetes (i.e., HbA1c > 8).
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 |
|---|---|---|
| Socket preservationAfter tooth extraction, the socket will be filled with a collagen plug and bone graft. | Device | Allograft, Synthetic bone, Xenograft |
Primary outcome
Clinical alveolar ridge dimension changes
Time frame: 4 months
Clinically measured alveolar ridge dimension changes in mm
3 secondary outcomes
Histological bone density
Time frame: 4 months
Presence of bone turnover proteins
Time frame: 4 months
Alveolar volumetric changes following tooth extraction
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Healing Wound
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
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.
Hom-Lay Wang, DDS,MSD,PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation in people with Healing Wound, 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 4 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 24 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical alveolar ridge dimension changes (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 24 Mar 2026.