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

NCT03468998 | Completed Results FDA Device

• 1 other identifier: RAP-17
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Alveolar Ridge Augmentation; Alveolar Ridge Preservation

Keywords

Bone allograft; Particle size; Ridge preservation; Ridge augmentation; Socket grafting; Histology; New bone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Study Arms (4)

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

Interventions

Socket Grafting with small particle allograft DEVICE

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

Ridge Preservation with Small Particle Allograft

Socket Grafting with large particle allograft DEVICE

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

Ridge Preservation with Large Particle Allograft

Lateral ridge augmentation with small particle allograft 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 Small Particle Allograft

Lateral ridge augmentation with large particle allograft 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

Ridge Augmentation with Large Particle Allograft

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-0007, United States

Location

Results Point of Contact

• Title: Ramzi Abou-Arraj
• Organization: University of Alabama at Birmingham

rva@uab.edu

2059341125

Study Officials

• Ramzi V Abou-Arraj, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 19, 2018
• Study Start: March 8, 2017
• Primary Completion: March 30, 2022
• Study Completion: December 15, 2022
• Last Updated: March 6, 2023
• Results First Posted: March 6, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)