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This study will evaluate the effect of allograft bone particle size on the bone quantity and quality following socket grafting and lateral ridge augmentation in preparation for endosseous implant placement.
Pre (baseline)- and post-grafting (3 months for sockets and 6 months for edentulous ridges) clinical as well as 2- and 3-dimensional radiographic measurements will be used to evaluate the differences between sites grafted with small vs. large particle sized bone allografts.
Histological analysis will be performed at time of surgical re-entry of grafted sites to place the dental implants, and assessed for differences in new bone formation between the 2 types of grafts.
This study is a prospective, two-arm, randomized trial that will evaluate and compare the bone healing following ridge preservation of extraction sockets (RP, Arms 1 and 2) or lateral ridge augmentation of edentulous sites (RA, Arms 3 and 4) using either small particle (SP) or large particle (LP) mineralized cortico-cancellous bone allografts in a total of 48 patients (12 in each arm).
Study approval was obtained from the university's institutional review board. Qualifying participants and defects are randomized following a computerized permutation block to receive either LP or SP allografts on day of surgery. In the RP arms, tooth extraction is performed with a flapless minimally invasive technique, followed by socket grafting with a randomized graft covered with a collagen dressing and sutures. In the RA arms, lateral ridge augmentation is conducted utilizing a randomized bone graft covered by a collagen membrane fixated with tacks.
The mineralized cortico-cancellous bone allografts utilized in this study were all obtained from the same donor, lot and tissue bank to account for variation in age, race, gender and related healing potential of different graft sources.
In the RP arm, bone core biopsies will be harvested at time of implant placement 3 months following socket grafting, whereas similar biopsies will be obtained at 6 months following lateral ridge augmentation in the RA group. These 2x2x6 mm bone cores will then undergo histological and histomorphometrical analyses to determine qualitative and quantitative healing differences between LP and SP in all study arms.
Clinical measurements are gathered at 2 time points (grating and implant placement) at all defects and will be compared for differences.
Cone beam computed tomography (CBCT) initial scans are conducted immediately following socket grafting (RP arms) and prior to ridge augmentation (RA arms) and second scans obtained prior to implant placement (all RP and RA arms). Virtual implant planning software (coDiagnostiX) will be utilized to assess and compare the 2- and 3-dimensional changes for all defects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ridge Preservation with Small Particle Allograft | Active Comparator |
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| Ridge Preservation with Large Particle Allograft | Active Comparator |
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| Ridge Augmentation with Small Particle Allograft | Active Comparator |
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| Ridge Augmentation with Large Particle Allograft | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Socket Grafting with small particle allograft | Device | Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket |
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| Measure | Description | Time Frame |
|---|---|---|
| New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | Compare histomorphometric amount of new bone formation (in %) between small and large particle bone allografts following ridge preservation and ridge augmentation procedures using core biopsies harvested at time of dental implant placement. | 3 months following socket preservation and 6 months following ridge augmentation |
| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | Using cone beam computed tomography and implant planning software, the bucco-lingual ridge width is measured (in mm) relative to a fixed digital reference and compared between the 2 bone particle groups | from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramzi V Abou-Arraj, DDS, MS | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294-0007 | United States |
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Randomization was performed by site in the mouth to receive either Small Particle (SP) or Large Particle (LP) Allograft. As a result, some participants received only one of the 2 interventions if they only had one qualifying site while other participants received both interventions if they had multiple sites that met the inclusion criteria in either of the study arms.
Ridge Preservation: # of SP sites=8 & # of LP sites=7. Ridge Augmentation: # of SP sites=7 & # of LP sites=12 .
| ID | Title | Description |
|---|---|---|
| FG000 | Ridge Preservation With Small Particle Allograft | Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket |
| FG001 | Ridge Preservation With Large Particle Allograft |
| 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 | Feb 6, 2022 |
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| Socket Grafting with large particle allograft | Device | Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket |
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| Lateral ridge augmentation with small particle allograft | Device | Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
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| Lateral ridge augmentation with large particle allograft | Device | Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
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Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket
| FG002 | Ridge Preservation With Small & Large Particle Allograft | This arm applies to patients who had more than 1 qualifying site for ridge preservation. Those sites were randomized to either small or large particles. |
| FG003 | Ridge Augmentation With Small Particle Allograft | Lateral ridge augmentation with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
| FG004 | Ridge Augmentation With Large Particle Allograft | Lateral ridge augmentation with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
| FG005 | Ridge Augmentation With Small & Large Particle Allograft | This arm applies to patients who had more than 1 qualifying site for ridge augmentation. Those sites were randomized to either small or large particles. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ridge Preservation With Small Particle Allograft | Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket |
| BG001 | Ridge Preservation With Large Particle Allograft | Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket |
| BG002 | Ridge Preservation With Small & Large Particle Allograft | This arm applies to patients who had more than 1 qualifying site for ridge preservation. Those sites were randomized to either small or large particles. |
| BG003 | Ridge Augmentation With Small Particle Allograft | Lateral ridge augmentation with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
| BG004 | Ridge Augmentation With Large Particle Allograft | Lateral ridge augmentation with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
| BG005 | Ridge Augmentation With Small & Large Particle Allograft | This arm applies to patients who had more than 1 qualifying site for ridge augmentation. Those sites were randomized to either small or large particles. |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Sites |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants | 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 | New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | Compare histomorphometric amount of new bone formation (in %) between small and large particle bone allografts following ridge preservation and ridge augmentation procedures using core biopsies harvested at time of dental implant placement. | Posted | Mean | Standard Deviation | % of new bone | 3 months following socket preservation and 6 months following ridge augmentation | Sites | Sites |
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| Secondary | Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | Using cone beam computed tomography and implant planning software, the bucco-lingual ridge width is measured (in mm) relative to a fixed digital reference and compared between the 2 bone particle groups | Posted | Mean | Standard Deviation | mm | from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation) | Sites | Sites |
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From baseline to 3 months following ridge preservation and from baseline to 6 months following ridge augmentation
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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 | Ridge Preservation With Small Particle Allograft | Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket | 0 | 6 | 0 | 6 | 0 | 6 |
| EG001 | Ridge Preservation With Large Particle Allograft | Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket | 0 | 6 | 0 | 6 | 0 | 6 |
| EG002 | Ridge Preservation With Small & Large Particle Allograft | This arm applies to patients who had more than 1 qualifying site for ridge preservation. Those sites were randomized to either small or large particles. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG003 | Ridge Augmentation With Small Particle Allograft | Lateral ridge augmentation with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Ridge Augmentation With Large Particle Allograft | Lateral ridge augmentation with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane | 0 | 9 | 0 | 9 | 0 | 9 |
| EG005 | Ridge Augmentation With Small & Large Particle Allograft | This arm applies to patients who had more than 1 qualifying site for ridge augmentation. Those sites were randomized to either small or large particles. | 0 | 2 | 0 | 2 | 0 | 2 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramzi Abou-Arraj | University of Alabama at Birmingham | 2059341125 | rva@uab.edu |
| Feb 2, 2023 |
| Prot_SAP_001.pdf |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Sites |
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| OG003 |
| Ridge Augmentation With Large Particle Allograft |
Lateral ridge augmentation with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane |
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