An interventional study of FDBA and CEBX in Ridge Preservation, Allografts and Extraction, Tooth, sponsored by University of Rochester. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by University of Rochester · Not applicable, Interventional, and Treatment
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:
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:
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.
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:
University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.
Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: FDBA
Device: CEBX
Twenty five participants will receive FDBA in anterior extraction sockets as part of the alveolar ridge preservation procedure.
Also known as: Freeze-dried bone allograft
Twenty five participants will receive CEBX in anterior extraction sockets as part of the alveolar ridge preservation procedure.
Also known as: Collagen-enriched bovine xenograft
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.
Time frame: baseline to 16 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.
Time frame: 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.
Time frame: 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.
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
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
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
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.
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
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.
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
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.
Time frame: 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.
Time frame: 12 months after implant placement, approximately 70 weeks
Plan to share: No
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