Trial Outcomes & Findings for The Influence of Bone Allograft Particle Sizes on the Quantity and Quality of New Bone Formation in Grafted Extraction Sockets and Edentulous Ridges (NCT NCT03468998)

Last Updated: 2023-03-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

37 participants

Primary outcome timeframe

3 months following socket preservation and 6 months following ridge augmentation

Results posted on

2023-03-06

Participant Flow

Randomization was performed by site in the mouth to receive either Small Particle (SP) or Large Particle (LP) Allograft. As a result, some participants received only one of the 2 interventions if they only had one qualifying site while other participants received both interventions if they had multiple sites that met the inclusion criteria in either of the study arms. Ridge Preservation: # of SP sites=8 \& # of LP sites=7. Ridge Augmentation: # of SP sites=7 \& # of LP sites=12 .

Unit of analysis: Sites

Participant milestones

Participant milestones
Measure	Ridge Preservation With Small Particle Allograft Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket	Ridge Preservation With Large Particle Allograft Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket	Ridge Preservation With Small & Large Particle Allograft This arm applies to patients who had more than 1 qualifying site for ridge preservation. Those sites were randomized to either small or large particles.	Ridge Augmentation With Small Particle Allograft 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	Ridge Augmentation With Large Particle Allograft 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	Ridge Augmentation With Small & Large Particle Allograft This arm applies to patients who had more than 1 qualifying site for ridge augmentation. Those sites were randomized to either small or large particles.
Overall Study STARTED	7 8	7 7	1 2	10 10	10 10	2 4
Overall Study COMPLETED	6 7	6 6	1 2	6 6	9 9	2 4
Overall Study NOT COMPLETED	1 1	1 1	0 0	4 4	1 1	0 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Ridge Preservation With Small Particle Allograft Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket	Ridge Preservation With Large Particle Allograft Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket	Ridge Preservation With Small & Large Particle Allograft This arm applies to patients who had more than 1 qualifying site for ridge preservation. Those sites were randomized to either small or large particles.	Ridge Augmentation With Small Particle Allograft 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	Ridge Augmentation With Large Particle Allograft 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	Ridge Augmentation With Small & Large Particle Allograft This arm applies to patients who had more than 1 qualifying site for ridge augmentation. Those sites were randomized to either small or large particles.
Overall Study Withdrawal by Subject	1	1	0	4	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ridge Preservation With Small Particle Allograft n=7 Sites Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket	Ridge Preservation With Large Particle Allograft n=6 Sites Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket	Ridge Preservation With Small & Large Particle Allograft n=2 Sites This arm applies to patients who had more than 1 qualifying site for ridge preservation. Those sites were randomized to either small or large particles.	Ridge Augmentation With Small Particle Allograft n=6 Sites 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	Ridge Augmentation With Large Particle Allograft n=9 Sites 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	Ridge Augmentation With Small & Large Particle Allograft n=4 Sites This arm applies to patients who had more than 1 qualifying site for ridge augmentation. Those sites were randomized to either small or large particles.	Total n=34 Sites Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	13 Participants n=115 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=10 Participants	17 Participants n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	16 Participants n=115 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	1 Participants n=10 Participants	14 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	2 Participants n=115 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	8 Participants n=21 Participants	2 Participants n=10 Participants	28 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants

PRIMARY outcome

Timeframe: 3 months following socket preservation and 6 months following ridge augmentation

Outcome measures

Outcome measures
Measure	Ridge Preservation With Small Particle Allograft n=8 Sites Socket Grafting with small particle allograft: Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket	Ridge Preservation With Large Particle Allograft n=7 Sites Socket Grafting with large particle allograft: Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket	Ridge Augmentation With Small Particle Allograft n=7 Sites 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	Ridge Augmentation With Large Particle Allograft n=12 Sites 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
New Bone Formation (in %) With the Use of Small vs. Large Particle Bone Allografts	17.3 % of new bone Standard Deviation 12.8	25.9 % of new bone Standard Deviation 9.5	41.0 % of new bone Standard Deviation 10.1	31.4 % of new bone Standard Deviation 14.8

SECONDARY outcome

Timeframe: 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