Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date February 2023
Source University of Alabama at Birmingham
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Device:
Socket Grafting with small particle allograft
Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket
Socket Grafting with large particle allograft
Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket
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
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

Locations

Country Name City State
United States University of Alabama at Birmingham Birmingham Alabama

Sponsors (1)

Lead Sponsor Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

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)
See also
  Status Clinical Trial Phase
Recruiting NCT05517798 - Enamel Matrix Derivative for Alveolar Ridge Preservation After Tooth Extraction N/A
Not yet recruiting NCT05553548 - Alveolar Ridge Changes With Biologically Oriented Alveolar Ridge Preservation (BARP) After Tooth Extraction N/A
Active, not recruiting NCT03374813 - Efficacy of MimetikOss in Alveolar Ridge Preservation Previous to Implant Placement N/A
Recruiting NCT06308536 - Application of Concentrated Growth Factors in Alveolar Ridge Preservation N/A
Active, not recruiting NCT05683509 - Alveolar Ridge Preservation With Layered Collagen and Xenograft N/A
Completed NCT02707536 - Influence of Platelet-Rich Fibrin on Post-extraction Alveolar Ridge Healing/Preservation as a Stand-alone or Adjunct to Particulate Graft N/A
Completed NCT03487718 - A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study. N/A
Not yet recruiting NCT06141239 - 2D/3D Imaging to Analyze the Regeneration Rate of Autologous Bone N/A
Not yet recruiting NCT06435754 - Hard and Soft Tissue Changes Following Vestibular Socket Preservation Versus Ice Cream Cone Technique for Management of Defective Fresh Extraction Sockets in the Esthetic Zone: A Randomized Clinical Trial N/A
Completed NCT04321109 - Alveolar Ridge Preservation Using Collagen Material and Allograft N/A
Terminated NCT04719624 - Novel Porous Bioceramic Material as a Bone Substitute N/A
Completed NCT03043885 - Ridge Preservation With Platelet Rich Fibrin Augmented With Freeze Dried Bone Allograft N/A
Recruiting NCT06275789 - Mix of Demineralized Freeze-Dried Bone Allograft and Deproteinized Bovine Bone Mineral: a Possible Solution for Alveolar Ridge Preservation? N/A
Recruiting NCT04296682 - Impact Of Soft Tissue Manipulation On Dimensional Changes After Posterior Region Extraction. N/A
Recruiting NCT05601531 - Autologous Tooth Root in Ridge Preservation N/A
Completed NCT03422458 - The Impact of Immediate Implant Placement on Alveolar Ridge Preservation Techniques N/A
Completed NCT05419778 - Alveolar Ridge Preservation Procedures
Completed NCT03447795 - Alveolar Ridge Preservation Using Autogenous Tooth Graft Versus Autogenous Demineralized Dentin Graft. N/A
Completed NCT05107141 - Ridge Preservation in Molar Sites Comparing Xenograft Versus Mineralized Freeze-dried Bone Allograft N/A
Active, not recruiting NCT04824235 - Alveolar Ridge Preservation Using Amniotic Chorion Membrane N/A