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The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.
The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % "CT/other" (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 Vallos (DCP) | Active Comparator | Subjects will be randomized into this group and receive DFDBA particulate alone |
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| Group 2 Vallomix (DCF) | Active Comparator | Subjects will be randomized into this group and receive DFDBA fibers alone |
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| Group 3 Vallos-F (DPX) | Active Comparator | Subjects will be randomized into this group and receive Xenograft combined with DCP |
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| Group 4 Vallomix-F (DFX) | Active Comparator | Subjects will be randomized into this group and receive Xenograft combined with DCF. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vallos (DCP) | Device | Demineralized freeze-dried bone allograft (DFBA) in a small particle form |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage Vital Bone Formation | Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery. | Wound healing time ( approximately 18 to 20 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Residual Graft Material | Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery. | Wound healing time ( approximately 18 to 20 weeks) |
| Percentage of Connective Tissue at Time of Implant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Mealey, DDS, MS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Angela Palaiologou-Gallis, DDS | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Health Science Center at San Antonio (Dental School) | San Antonio | Texas | 78229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42312399 | Derived | Yineman KJ, Palaiologou AA, Powell CA, Deas DE, Mealey BL. Palatal donor site wound healing following mucogingival surgery using amnion-chorion membrane: A randomized controlled clinical trial. J Periodontol. 2026 Jun 18. doi: 10.1002/jper.70147. Online ahead of print. | |
| 40702945 | Derived | Foster JE, Coleman CC, Palaiologou AA, Mealey BL. Healing following ridge preservation using demineralized allograft particles or fibers alone, and combined with xenograft. J Periodontol. 2026 Jan;97(1):23-33. doi: 10.1002/jper.11374. Epub 2025 Jul 24. |
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De-identified data will be shared as summary results on ClinicalTrials.gov and in a peer-review journal.
After study completion and after data are analyzed.
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All patients presented with one non-molar tooth that was indicated for extraction and planned for an implant restoration. Additional inclusion criteria included the following: 1) adequate restorative space for an implant restoration, 2) at least 10mm of alveolar ridge height before any vital structures, and 3) non-smokers or current smokers smoking <10 cigarettes per day.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 Vallos (DCP) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form |
| FG001 | Group 2 Vallomix (DPX) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 14, 2022 |
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4 arm randomized controlled parallel study
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Since the outcome of the study is the histologic healing, blinding of the surgeon is not necessary.
Blinding is performed only for histomorphometric measurements. The person doing histomorphometric analysis is blinded as to study group.
| Vallomix (DCF) | Device | A combination of cow-derived xenograft and human-derived DFDBA particulate |
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| Vallos-F (DPX) | Device | Demineralized freeze-dried bone allograft (DFDBA) in a fiber form |
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| Vallomix-F (DFX) | Device | A combination of cow-derived xenograft and human-derived DFDBA fibers |
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Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery. |
| Baseline to 18-20 weeks |
| Change in Ridge Width (Clinical Measurement) | Measure of change in ridge width from extraction to healing time | Baseline to 18-20 weeks |
| Change in Buccal Ridge Height (Clinical Measurement) | Measure of change in buccal ridge height from extraction to healing time | Baseline to 18-20 weeks |
| Change in Lingual Ridge Height (Clinical Measurement) | Measure of change in lingual ridge height from extraction to healing time | Baseline to 18-20 weeks |
Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate |
| FG002 | Group 3 Vallos-F (DCF) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form |
| FG003 | Group 4 Vallomix-F (DFX) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers |
| Completed Histologic Analysis |
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| Completed Clinical Measurements |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 Vallos (DCP) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form |
| BG001 | Group 2 Vallomix (DPX) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate |
| BG002 | Group 3 Vallos-F (DCF) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form |
| BG003 | Group 4 Vallomix-F (DFX) | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Vital Bone Formation | Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery. | Posted | Mean | Standard Deviation | percentage of vital bone formation | Wound healing time ( approximately 18 to 20 weeks) |
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| Secondary | Percentage of Residual Graft Material | Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery. | Posted | Mean | Standard Deviation | percentage of residual graft material | Wound healing time ( approximately 18 to 20 weeks) |
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| Secondary | Percentage of Connective Tissue at Time of Implant | Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery. | Posted | Mean | Standard Deviation | percentage of connective tissue | Baseline to 18-20 weeks |
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| Secondary | Change in Ridge Width (Clinical Measurement) | Measure of change in ridge width from extraction to healing time | Posted | Mean | Standard Deviation | mm | Baseline to 18-20 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Buccal Ridge Height (Clinical Measurement) | Measure of change in buccal ridge height from extraction to healing time | Posted | Mean | Standard Deviation | mm | Baseline to 18-20 weeks |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Lingual Ridge Height (Clinical Measurement) | Measure of change in lingual ridge height from extraction to healing time | Posted | Mean | Standard Deviation | mm | Baseline to 18-20 weeks |
|
Baseline to 18-20 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 Vallos | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallos: Demineralized freeze-dried bone allograft (DFBA) in a small particle form | 0 | 24 | 0 | 24 | 0 | 24 |
| EG001 | Group 2 Vallos-F | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallos-F: Demineralized freeze-dried bone allograft (DFDBA) in a fiber form | 0 | 27 | 1 | 27 | 0 | 27 |
| EG002 | Group 3 Vallomix | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallomix: A combination of cow-derived xenograft and human-derived DFDBA particulate | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Group 4 Vallomix-F | Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. Vallomix-F: A combination of cow-derived xenograft and human-derived DFDBA fibers | 0 | 27 | 0 | 27 | 0 | 27 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bleeding | Blood and lymphatic system disorders | Non-systematic Assessment | Participant experienced bleeding related to the dental procedure, rather than the intervention |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Mealeey, DDS, MS | University of Texas Health Science Center at San Antonio | 210-450-8736 | mealey@uthscsa.edu |
| May 20, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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