The Influence of Bone Allograft Particle Sizes on the Quantity and Quality of New Bone Formation in Grafted Extraction Sockets and Edentulous Ridges

NCT ID: NCT03468998

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-08
• Study Completion Date: 2022-12-15

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.

Conditions

Alveolar Ridge Augmentation; Alveolar Ridge Preservation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ridge Preservation with Small Particle Allograft

Group Type: ACTIVE_COMPARATOR

Socket Grafting with small particle allograft

Intervention Type: DEVICE

Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket

Ridge Preservation with Large Particle Allograft

Group Type: ACTIVE_COMPARATOR

Socket Grafting with large particle allograft

Intervention Type: DEVICE

Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket

Ridge Augmentation with Small Particle Allograft

Group Type: ACTIVE_COMPARATOR

Lateral ridge augmentation with small particle allograft

Intervention Type: 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

Ridge Augmentation with Large Particle Allograft

Group Type: ACTIVE_COMPARATOR

Lateral ridge augmentation with large particle allograft

Intervention Type: 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

Interventions

Socket Grafting with small particle allograft

Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket

Intervention Type: DEVICE

Socket Grafting with large particle allograft

Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Ramzi V. Abou-Arraj

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ramzi V Abou-Arraj, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RAP-17

Identifier Type: -

Identifier Source: org_study_id