NCT03468998

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

Completed NA Results posted Last updated 6 March 2023

What this trial tests

NA trial testing Socket Grafting with small particle allograft in Alveolar Ridge Augmentation in 37 participants. Completed in 15 December 2022.

Timeline

8 March 2017

Primary endpoint
30 March 2022

15 December 2022

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	37
Start date	8 March 2017
Primary completion	30 March 2022
Estimated completion	15 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Socket Grafting with small particle allograft
• Socket Grafting with large particle allograft
• Lateral ridge augmentation with small particle allograft
• Lateral ridge augmentation with large particle allograft

Conditions studied

• Alveolar Ridge Augmentation — all drugs for Alveolar Ridge Augmentation →
• Alveolar Ridge Preservation — all drugs for Alveolar Ridge Preservation →

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 99, any sex, with Alveolar Ridge Augmentation or Alveolar Ridge Preservation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts Primary · 3 months following socket preservation and 6 months following ridge augmentation

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.

Group	Value	95% CI
Ridge Preservation With Small Particle Allograft	17.3	± 12.8
Ridge Preservation With Large Particle Allograft	25.9	± 9.5
Ridge Augmentation With Small Particle Allograft	41.0	± 10.1
Ridge Augmentation With Large Particle Allograft	31.4	± 14.8

Radiographic Ridge Dimensional Changes (in mm) as a Result of Ridge Preservation and Ridge Augmentation Using Small vs. Large Particle Allograft Secondary · from time of grafting until implant placement (3 months following ridge preservation and 6 months following ridge augmentation)

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

Group	Value	95% CI
Ridge Preservation With Small Particle Allograft	1.1	± 0.7
Ridge Preservation With Large Particle Allograft	0.8	± 0.5
Ridge Augmentation With Small Particle Allograft	3.7	± 1.3
Ridge Augmentation With Large Particle Allograft	5.1	± 1.7

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.