Alveolar Ridge AugmentationNCT03468998
The Influence of Bone Allograft Particle Sizes on the Quantity and Quality of New Bone Formation in Grafted Extraction Sockets and Edentulous Ridges
A study testing Socket Grafting with small particle allograft, Socket Grafting with large particle allograft and Lateral ridge augmentation with small particle allograft in people with Alveolar Ridge Augmentation and Alveolar Ridge Preservation, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Ridge Augmentation, Alveolar Ridge Preservation
- What is being tested?
- Socket Grafting with small particle allograft, Socket Grafting with large particle allograft and Lateral ridge augmentation with small particle allograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2017to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
About this study
Official title: A Randomized Trial to Evaluate the Effect of Allograft Bone Particle Size on Histomorphometric and Clinical Outcomes Following Ridge Preservation/Augmentation Procedures
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.
Read the 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.
- Being tested
- Socket Grafting with small particle allograft, Socket Grafting with large particle allograft, Lateral ridge augmentation with small particle allograft, Lateral ridge augmentation with large particle allograft
- Keywords
- Bone allograft, Particle size, Ridge preservation, Ridge augmentation, Socket grafting, Histology, New bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket Grafting with small particle allograftDevice
Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket
Socket Grafting with large particle allograftDevice
Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket
Lateral ridge augmentation with small particle allograftDevice
Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane
Lateral ridge augmentation with large particle allograftDevice
Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane
| Study group | Role | What they receive |
|---|---|---|
| Ridge Preservation with Small Particle Allograft | Active comparator | Not described Receives: Device: Socket Grafting with small particle allograft |
| Ridge Preservation with Large Particle Allograft | Active comparator | Not described Receives: Device: Socket Grafting with large particle allograft |
| Ridge Augmentation with Small Particle Allograft | Active comparator | Not described Receives: Device: Lateral ridge augmentation with small particle allograft |
| Ridge Augmentation with Large Particle Allograft | Active comparator | Not described Receives: Device: Lateral ridge augmentation with large particle allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months following socket preservation and 6 months following ridge augmentation
Secondary outcomes (1)
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
Measured: from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start8 Mar 2017
- Primary completion30 Mar 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alveolar Ridge AugmentationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramzi V. Abou-Arraj, University of Alabama at Birmingham
- Investigators
- Ramzi V Abou-Arraj, DDS, MS, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468998
- Sponsor's protocol ID
- RAP-17
- Status last verified
- Feb 2023
- First submitted
- 12 Mar 2018
- Last updated
- 6 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- 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 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate the Effect of Allograft Bone Particle Size on Histomorphometric and Clinical Outcomes Following Ridge Preservation/Augmentation Procedures
- ClinicalTrials.gov ID
- NCT03468998
- Acronym / sponsor ID
- RAP-17
- Keywords
- Bone allograft, Particle size, Ridge preservation, Ridge augmentation, Socket grafting, Histology, New bone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 8 Mar 2017 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Posted 6 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ridge Preservation with Small Particle Allograft | Active comparator | Device: Socket Grafting with small particle allograft |
| Ridge Preservation with Large Particle Allograft | Active comparator | Device: Socket Grafting with large particle allograft |
| Ridge Augmentation with Small Particle Allograft | Active comparator | Device: Lateral ridge augmentation with small particle allograft |
| Ridge Augmentation with Large Particle Allograft | Active comparator | Device: Lateral ridge augmentation with large particle allograft |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
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 |
|---|---|---|
| Socket Grafting with small particle allograftSmall Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket | Device | Ridge Preservation with Small Particle Allograft |
| Socket Grafting with large particle allograftLarge Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket | Device | Ridge Preservation with Large Particle Allograft |
| Lateral ridge augmentation with small particle allograftSmall Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane | Device | Ridge Augmentation with Small Particle Allograft |
| Lateral ridge augmentation with large particle allograftLarge Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane | Device | Ridge Augmentation with Large Particle Allograft |
Primary outcome
New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts
Time frame: 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.
1 secondary outcome
Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft
Time frame: from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
Ramzi V Abou-Arraj, DDS, MS principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket Grafting with small particle allograft, Socket Grafting with large particle allograft and Lateral ridge augmentation with small particle allograft in people with Alveolar Ridge Augmentation and Alveolar Ridge Preservation, run by University of Alabama at Birmingham 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 6 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 6 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts (time frame: 3 months following socket preservation and 6 months following ridge augmentation). 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 6 Mar 2023.