N/A N=37 Randomized Double-blind Treatment

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

Alveolar Ridge Augmentation · Alveolar Ridge Preservation

Bottom Line

View on ClinicalTrials.gov: NCT03468998 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2023

Primary outcome: Primary: New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts — 17.3; 25.9; 41.0; 31.4 % of new bone

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Socket Grafting with small particle allograft (Device); Socket Grafting with large particle allograft (Device); Lateral ridge augmentation with small particle allograft (Device); Lateral ridge augmentation with large particle allograft (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Alabama at Birmingham
Primary completion: Mar 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts	17.3; 25.9; 41.0; 31.4	—
SECONDARY Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft	1.1; 0.8; 3.7; 5.1	—

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.

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03468998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.