Alveolar Ridge Preservation Clinical Trial
Official title:
A Randomized Trial to Evaluate the Effect of Allograft Bone Particle Size on Histomorphometric and Clinical Outcomes Following Ridge Preservation/Augmentation Procedures
NCT number | NCT03468998 |
Other study ID # | RAP-17 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 8, 2017 |
Est. completion date | December 15, 2022 |
Verified date | February 2023 |
Source | University of Alabama at Birmingham |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 37 |
Est. completion date | December 15, 2022 |
Est. primary completion date | March 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
Lead Sponsor | Collaborator |
---|---|
University of Alabama at Birmingham |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | 3 months following socket preservation and 6 months following ridge augmentation | |
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 | from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation) |
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