Alveolar Ridge Augmentation, Alveolar Ridge Preservation
Conditions
Keywords
Bone allograft, Particle size, Ridge preservation, Ridge augmentation, Socket grafting, Histology, New bone
Brief summary
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.
Detailed description
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.
Interventions
DEVICESocket Grafting with small particle allograft
Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket
DEVICESocket Grafting with large particle allograft
Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket
DEVICELateral 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
DEVICELateral 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
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* English speaking * At least 18 years old * Must be a patient of the UAB Dental School * Able to read and understand informed consent document * Need for implants to replace missing tooth or teeth in at least one quadrant of the mouth. * Hopeless tooth or teeth planned to be replaced with dental implant(s)\_socket with residual 4 walls following minimally invasive tooth extraction (a dehiscence of \<3mm may be included) or insufficient alveolar ridge width for endosseous implant placement defined as 5mm or less as determined by bone sounding and cone beam computed tomography (CBCT) scan. * Patient and/or guardian is willing and able to comply with the preoperative and postoperative diagnostic and clinical evaluations required.
Exclusion criteria
* Non-English speaking * Less than 18 years old * Smokers/tobacco users (\>10 cigarettes/day) * Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing * Patients with significant medical conditions or habits expected to interfere with bony healing. * Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug abuse) * Bone dehiscence of \>4mm following tooth extraction or Vertical loss of bone at edentulous ridge
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | 3 months following socket preservation and 6 months following ridge augmentation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation) | 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 |
Countries
United States
Participant flow
Recruitment details
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 .
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 7 |
| 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 | 6 |
| 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 | 6 |
| 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. | 1 |
| 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. | 2 |
| 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 | 6 |
| 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 | 6 |
| 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 | 9 |
| 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 | 9 |
| 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. | 2 |
| 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. | 4 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 4 | 1 | 0 |
Baseline characteristics
| Characteristic | Ridge Preservation With Large Particle Allograft | Ridge Preservation With Small & Large Particle Allograft | Ridge Augmentation With Small Particle Allograft | Ridge Preservation With Small Particle Allograft | Ridge Augmentation With Large Particle Allograft | Ridge Augmentation With Small & Large Particle Allograft | Total |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 0 Participants | 3 Participants | 5 Participants | 5 Participants | 2 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 3 Participants | 1 Participants | 4 Participants | 0 Participants | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 1 Participants | 5 Participants | 6 Participants | 8 Participants | 2 Participants | 28 Participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants | 2 Participants | 5 Participants | 1 Participants | 16 Participants |
| Sex: Female, Male Male | 3 Participants | 0 Participants | 2 Participants | 4 Participants | 4 Participants | 1 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 1 | 0 / 6 | 0 / 9 | 0 / 2 |
| other Total, other adverse events | 0 / 6 | 0 / 6 | 0 / 1 | 0 / 6 | 0 / 9 | 0 / 2 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 1 | 0 / 6 | 0 / 9 | 0 / 2 |
Outcome results
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.
Time frame: 3 months following socket preservation and 6 months following ridge augmentation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ridge Preservation With Small Particle Allograft | New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | 17.3 % of new bone | Standard Deviation 12.8 |
| Ridge Preservation With Large Particle Allograft | New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | 25.9 % of new bone | Standard Deviation 9.5 |
| Ridge Augmentation With Small Particle Allograft | New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | 41.0 % of new bone | Standard Deviation 10.1 |
| Ridge Augmentation With Large Particle Allograft | New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts | 31.4 % of new bone | Standard Deviation 14.8 |
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
Time frame: from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ridge Preservation With Small Particle Allograft | Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | 1.1 mm | Standard Deviation 0.7 |
| Ridge Preservation With Large Particle Allograft | Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | 0.8 mm | Standard Deviation 0.5 |
| Ridge Augmentation With Small Particle Allograft | Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | 3.7 mm | Standard Deviation 1.3 |
| Ridge Augmentation With Large Particle Allograft | Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft | 5.1 mm | Standard Deviation 1.7 |