Ridge PreservationFDBA or CEBXNCT06722482
Comparison of Two Types of Bone Grafts in Patients Who Need One of Their Front Teeth Removed and Replaced With an Implant
A study testing FDBA and CEBX in people with Ridge Preservation and Allografts, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ridge Preservation, Allografts, Extraction, Tooth
- What is being tested?
- FDBA and CEBX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2023to 1 Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients able to provide informed consent
- patients of 18 years of age or older at time of consent and enrollment
- patients in need of at least one anterior tooth extraction and seeking dental implant replacement
- bone on the buccal of the central/lateral incisors or canines planned for extraction that is either intact or has a dehiscence </=5mm as determined radiographically through cone beam computed tomography (CBCT)
Who cannot join
- current smokers or tobacco-product users (self-reported)
- uncontrolled diabetes (HbA1c≥7 in the last 3 months)
- pregnant and/or lactating females (self-reported)
- patients on immunosuppressants, steroids, bisphosphonates or other medications that have been related to Medication-Related Osteonecrosis of the Jaw (MRONJ) as described by the American Association of Oral Maxillofacial Surgeons (AAOMS) 2014 update
- patients with history of radiation of the head and neck
- patients with allergy to collagen, bacitracin and/or polymyxin B
Show all 11Show fewer
- patients with religious or cultural beliefs that prohibit the use of either allograft or bovine graft material
- patients with physical and/or mental/cognitive disabilities (self-reported) or decisionally-impaired, not able to consent for themselves
- patients with untreated periodontitis
- patients with central/lateral incisors or canines requiring extraction and are adjacent to an edentulous area
- patients with central/lateral incisors or canines with buccal bone dehiscence >5mm
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nasser Assery, BDS, MS contact
United States1 site, 1 recruiting
- Recruiting
Eastman Institute for Oral Health
Rochester, New York, 14620
Elli Anna Kotsailidi, DDS, MS, 5856429948, elli_kotsailidi@urmc.rochester.edu
Nasser Assery, BDS, MS, nasser_assery@umc.rochester.edu
About this study
Official title: Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.
The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material.
The study aims to examine the following main questions:
Read more
- Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing
- Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated.
The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as:
- Demographic information
- Clinical information from intraoral photographs
- Radiographic information from cone beam computed tomography and periapical radiographs.
Read the detailed description
The study will compare clinical, radiographic (dental cone beam computed tomography) and histologic outcomes upon tooth extraction and alveolar ridge preservation (ARP) as well as clinical, radiographic and patient-reported outcomes upon implant placement and crown fabrication at the same site.
Both bone graft materials (FDBA and CEBX) are FDA approved and are widely available in the US market and are routinely used in everyday practices and within the university.
- FDBA is produced by Community Blood Center (Community Tissue Services, Ohio, USA) (FEI: 3008808182).
- CEBX is produced by Geistlich Pharma AG (Wolhusen, Switzerland) [501(k) #: K122894].
Both materials will be stored and utilized based on manufacturers' recommendations and as per of Standard of Care protocols within the university.
Participants and investigators will be unaware of the envelope content and each participant will be asked to randomly pick an envelope and immediately both the participant as well as the investigator will be informed about the envelope content and, therefore, the group allocation. Eventually, participants and investigators will be aware of the group allocation, except for the investigator who will conduct all the study measurements who will remain blinded.
Upon healing, both groups will receive similar treatment as far as implant placement and crown restoration is concerned.
Interventions and procedures
The study-related interventions and procedures will more specifically include:
- Evaluation of horizontal and vertical ridge dimensional changes as well as contour changes upon standard of care procedures (alveolar ridge preservation) through cone beam computed tomography and intraoral scanning, respectively, after 16 weeks of healing.
- Determination of the feasibility of prosthetically driven implant placement upon standard of care evaluation of the post-healing cone beam computed tomography, at 16 weeks after ARP.
- Histological evaluation of the healed grafted area upon grafting with frequently used bone graft materials at 16 weeks of healing.
- Assessment of peri-implant clinical and radiographic parameters as well as crown esthetics and patient satisfaction upon 12 months from the dental implant placement.
- Conditions
- Ridge Preservation, Allografts, Extraction, Tooth, Xenograft
- Being tested
- FDBA, CEBX
- Keywords
- alveolar ridge preservation, tooth extraction, freeze-dried bone allograft, collagen-enriched bovine xenograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDBADevice
Also called Freeze-dried bone allograft
Twenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.
CEBXDevice
Also called Collagen-enriched bovine xenograft
Twenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.
| Study group | Role | What they receive |
|---|---|---|
| FDBA arm | Experimental | Not described Receives: Device: FDBA |
| CEBX arm | Active comparator | Not described Receives: Device: CEBX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change in radiographic horizontal and vertical ridge dimensions
Linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes will be measured and compared between groups after 16 weeks of healing.
Measured: baseline to 16 weeks after surgery
Secondary outcomes (15)
Mean change in alveolar ridge contour
Alveolar ridge contour changes as they appear on intraoral optical scans will be measured and compared between groups.
Measured: baseline to 4 weeks after surgery
Mean change in alveolar ridge contour
Alveolar ridge contour changes as they appear on intraoral optical scans will be measured and compared between groups.
Measured: baseline to 2 months after implant placement, approximately 24 weeks
Mean change in alveolar ridge contour
Alveolar ridge contour changes as they appear on intraoral optical scans will be measured and compared between groups.
Measured: baseline to 12 months after implant placement, approximately 70 weeks
Number of implants/participants with an implant placed on a prosthetically driven position
Feasibility of prosthetically driven implant placement will be assessed with an implant planning software on the cone beam computed tomography obtained at 16 weeks after the ARP, and compared between groups
Measured: 16 weeks
Mean percentage of residual bone graft particles
Histologic evaluation of grafted sites from both groups will be performed at the time of implant osteotomy preparation, 16 weeks upon the ARP surgery.
Parameters such as residual bone graft particles, new bone formation and connective tissue will be assessed and compared between groups.
Measured: 16 weeks
Mean percentage of new bone formation
Histologic evaluation of grafted sites from both groups will be performed at the time of implant osteotomy preparation, 16 weeks upon the ARP surgery.
Parameters such as residual bone graft particles, new bone formation and connective tissue will be assessed and compared between groups.
Measured: 16 weeks
Mean percentage of connective tissue
Histologic evaluation of grafted sites from both groups will be performed at the time of implant osteotomy preparation, 16 weeks upon the ARP surgery.
Parameters such as residual bone graft particles, new bone formation and connective tissue will be assessed and compared between groups.
Measured: 16 weeks
Mean probing depth
Probing depths will be recoded at 6 sites on each implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual) with a periodontal probe to the nearest mm. Mean probing depths will be compared between groups at 2 and 12 months after the implant placement.
Measured: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean percentage of implant surfaces with bleeding
Presence or absence of bleeding upon probing with a periodontal probe will be recoded at 6 sites on each implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The mean percentage of bleeding will be compared between groups at 2 and 12 months after the implant placement.
Measured: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean percentage of implant surfaces with plaque
Presence or absence of plaque that can be collected with a periodontal probe will be recoded at 6 sites on each implant (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, disto-lingual). The mean percentage of plaque will be compared between groups at 2 and 12 months after the implant placement.
Measured: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean width of keratinized mucosa
The width of the keratinized mucosa will be measured to the nearest mm with a periodontal probe on the mid-facial and mid-lingual aspect of each implant. The mean width of keratinized mucosa will be compared between groups at 2 and 12 months after the implant placement.
Measured: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean migration of peri-implant mucosal margin
The migration of the peri-implant mucosal margin will be measured to the nearest mm with a periodontal probe on the mid-facial and mid-lingual/palatal aspect of each implant. The mean migration of peri-implant mucosal level will be compared between groups at 2 and 12 months after the implant placement.
Measured: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean change peri-implant marginal bone level changes
Peri-implant marginal bone level changes from implant placement to 2 and 12 months after the implant placement will be evaluated and compared through standardized bitewing radiographs.
Measured: 16 weeks to 2 months after implant placement (approximately 8 weeks) and 16 weeks to 12 months after implant placement (approximately 54 weeks)
Mean implant-crown esthetic score
Implant crown esthetics will be evaluated through the Pink Esthetic Score (PES) at 12 months after the implant placement. The PES ranges from 0-12 with higher scores indicating better outcome.
Measured: 12 months after implant placement, approximately 70 weeks
Mean patient satisfaction score
Patient satisfaction will be evaluated and compared with a two-item survey, including the following questions to be answered using the 0-10 Visual Analogue Scale (VAS):
- "Are you satisfied with the final outcome?"
- "Would you undergo the same procedure in the future?" Scores range from 0-20 with higher scores indicating higher satisfaction.
Measured: 12 months after implant placement, approximately 70 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start27 Nov 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge PreservationStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Model description
- single center, pilot, randomized, clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Implant Dentistry Research & Education Foundation (IDREF)
- Responsible party
- Principal investigator, Elli Kotsailidi, University of Rochester
- Investigators
- Elli Anna Kotsailidi, DDS, MS, Principal investigator, Eastman Institute for Oral Health, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722482
- Sponsor's protocol ID
- STUDY00008216
- Other IDs
- AWD00006192
- Acronym
- FDBA or CEBX
- Status last verified
- Jan 2026
- First submitted
- 2 Dec 2024
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Freeze-Dried Bone Allograft Compared to Collagen-Enriched Bovine Xenograft for Alveolar Ridge Preservation of Anterior Extraction Sockets.
- ClinicalTrials.gov ID
- NCT06722482
- Acronym / sponsor ID
- FDBA or CEBX / STUDY00008216
- Conditions
- Ridge Preservation, Allografts, Extraction, Tooth, Xenograft
- Keywords
- alveolar ridge preservation, tooth extraction, freeze-dried bone allograft, collagen-enriched bovine xenograft
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Implant Dentistry Research & Education Foundation (IDREF)
- Study start
- 27 Nov 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 9 Dec 2024 (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.
The purpose of this study is to compare two different bone graft materials (freeze-dried bone allograft, FDBA and collagen-enriched bovine xenograft, CEBX) that are routinely used for preserving the remaining bone after extraction of an anterior tooth, and before placing a dental implant. Patients will be randomly assigned to either group (flip of a coin) One group will receive FDBA material and the other group will receive CEBX (cow) material.
The study aims to examine the following main questions:
- Potential differences in linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes between groups after 16 weeks of healing
- Other clinical information of the treated areas and information regarding the esthetics of the dental implant that will subsequently be placed at the edentulous site as well as patient satisfaction with the treatment, will be evaluated.
The study will include 7 study visits. Study procedures will take place during the same visits as the standard of care treatments (tooth extraction and bone graft, dental implant placement, crown installation and follow-ups). Clinical information from these standard of care visits will be used for the current research study, such as:
- Demographic information
- Clinical information from intraoral photographs
- Radiographic information from cone beam computed tomography and periapical radiographs.
Detailed description
The study will compare clinical, radiographic (dental cone beam computed tomography) and histologic outcomes upon tooth extraction and alveolar ridge preservation (ARP) as well as clinical, radiographic and patient-reported outcomes upon implant placement and crown fabrication at the same site.
Both bone graft materials (FDBA and CEBX) are FDA approved and are widely available in the US market and are routinely used in everyday practices and within the university.
- FDBA is produced by Community Blood Center (Community Tissue Services, Ohio, USA) (FEI: 3008808182).
- CEBX is produced by Geistlich Pharma AG (Wolhusen, Switzerland) [501(k) #: K122894].
Both materials will be stored and utilized based on manufacturers' recommendations and as per of Standard of Care protocols within the university.
Participants and investigators will be unaware of the envelope content and each participant will be asked to randomly pick an envelope and immediately both the participant as well as the investigator will be informed about the envelope content and, therefore, the group allocation. Eventually, participants and investigators will be aware of the group allocation, except for the investigator who will conduct all the study measurements who will remain blinded.
Upon healing, both groups will receive similar treatment as far as implant placement and crown restoration is concerned.
Interventions and procedures
The study-related interventions and procedures will more specifically include:
- Evaluation of horizontal and vertical ridge dimensional changes as well as contour changes upon standard of care procedures (alveolar ridge preservation) through cone beam computed tomography and intraoral scanning, respectively, after 16 weeks of healing.
- Determination of the feasibility of prosthetically driven implant placement upon standard of care evaluation of the post-healing cone beam computed tomography, at 16 weeks after ARP.
- Histological evaluation of the healed grafted area upon grafting with frequently used bone graft materials at 16 weeks of healing.
- Assessment of peri-implant clinical and radiographic parameters as well as crown esthetics and patient satisfaction upon 12 months from the dental implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- single center, pilot, randomized, clinical trial
| Arm | Type | Receives |
|---|---|---|
| FDBA arm | Experimental | Device: FDBA |
| CEBX arm | Active comparator | Device: CEBX |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients able to provide informed consent
- patients of 18 years of age or older at time of consent and enrollment
- patients in need of at least one anterior tooth extraction and seeking dental implant replacement
- bone on the buccal of the central/lateral incisors or canines planned for extraction that is either intact or has a dehiscence </=5mm as determined radiographically through cone beam computed tomography (CBCT)
Key exclusion criteria (11 listed)
- current smokers or tobacco-product users (self-reported)
- uncontrolled diabetes (HbA1c≥7 in the last 3 months)
- pregnant and/or lactating females (self-reported)
- patients on immunosuppressants, steroids, bisphosphonates or other medications that have been related to Medication-Related Osteonecrosis of the Jaw (MRONJ) as described by the American Association of Oral Maxillofacial Surgeons (AAOMS) 2014 update
- patients with history of radiation of the head and neck
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 |
|---|---|---|
| FDBAAlso: Freeze-dried bone allograftTwenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure. | Device | FDBA arm |
| CEBXAlso: Collagen-enriched bovine xenograftTwenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure. | Device | CEBX arm |
Primary outcome
Mean change in radiographic horizontal and vertical ridge dimensions
Time frame: baseline to 16 weeks after surgery
Linear radiographic horizontal (HRD) and vertical (VRD) ridge dimensional changes will be measured and compared between groups after 16 weeks of healing.
15 secondary outcomes
Mean change in alveolar ridge contour
Time frame: baseline to 4 weeks after surgery
Mean change in alveolar ridge contour
Time frame: baseline to 2 months after implant placement, approximately 24 weeks
Mean change in alveolar ridge contour
Time frame: baseline to 12 months after implant placement, approximately 70 weeks
Number of implants/participants with an implant placed on a prosthetically driven position
Time frame: 16 weeks
Mean percentage of residual bone graft particles
Time frame: 16 weeks
Mean percentage of new bone formation
Time frame: 16 weeks
Mean percentage of connective tissue
Time frame: 16 weeks
Mean probing depth
Time frame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean percentage of implant surfaces with bleeding
Time frame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean percentage of implant surfaces with plaque
Time frame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean width of keratinized mucosa
Time frame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean migration of peri-implant mucosal margin
Time frame: 2 months after implant placement (approximately 24 weeks) and 12 months after implant placement (approximately 70 weeks)
Mean change peri-implant marginal bone level changes
Time frame: 16 weeks to 2 months after implant placement (approximately 8 weeks) and 16 weeks to 12 months after implant placement (approximately 54 weeks)
Mean implant-crown esthetic score
Time frame: 12 months after implant placement, approximately 70 weeks
Mean patient satisfaction score
Time frame: 12 months after implant placement, approximately 70 weeks
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 9 Jan 2026.
- 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.
Nasser Assery, BDS, MS contact
Elli Anna Kotsailidi, DDS, MS principal investigator
Eastman Institute for Oral Health, University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FDBA and CEBX in people with Ridge Preservation and Allografts, run by University of Rochester 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 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: looking for participants now, as of the sponsor's last update on 9 Jan 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?
Contact Elli Anna Kotsailidi, DDS, MS (585-274-1146, elli_kotsailidi@urmc.rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in radiographic horizontal and vertical ridge dimensions (time frame: baseline to 16 weeks 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 9 Jan 2026.