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Ridge Preservation After Tooth Extraction Using Cortical Versus Cancellous Freeze Dried Bone Allograft

Histological Comparison of Healing Following Tooth Extraction With Ridge Preservation Using Cortical Versus Cancellous Freeze Dried Bone Allograft

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01588444
Enrollment
40
Registered
2012-05-01
Start date
2010-10-31
Completion date
2012-07-31
Last updated
2015-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Extraction

Keywords

tooth extraction, bone grafting

Brief summary

The purpose of this study is to compare cortical and cancellous freeze-dried bone allograft (FDBA) materials in the preservation of alveolar bone following extraction of non-molar teeth. The primary objective is to histologically evaluate and compare the healing of extraction sockets of non-molar teeth grafted with cortical FDBA versus cancellous FDBA for ridge preservation.

Interventions

DEVICEcortical FDBA

cortical mineralized freeze-dried bone allograft

DEVICECancellous FDBA

CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)

Sponsors

The University of Texas Health Science Center at San Antonio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* single rooted tooth requiring extraction with future dental implant placement

Exclusion criteria

* smoking \> 10 cigarettes per day poorly controlled diabetes

Design outcomes

Primary

MeasureTime frameDescription
Histologic Percentage of Vital Bone Formation18-20 weeks after graftingHistologic percentage of vital bone formation in bone cores

Countries

United States

Participant flow

Participants by arm

ArmCount
Cancellous FDBA (LifeNet)
grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health) Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
20
Cortical FDBA (LifeNet)
CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health) cortical FDBA: cortical mineralized freeze-dried bone allograft
20
Total40

Baseline characteristics

CharacteristicCancellous FDBA (LifeNet)Cortical FDBA (LifeNet)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants4 Participants7 Participants
Age, Categorical
Between 18 and 65 years
17 Participants16 Participants33 Participants
Age, Continuous53.4 years55.6 years54 years
Region of Enrollment
United States
20 participants20 participants40 participants
Sex: Female, Male
Female
9 Participants10 Participants19 Participants
Sex: Female, Male
Male
11 Participants10 Participants21 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 200 / 20
serious
Total, serious adverse events
0 / 200 / 20

Outcome results

Primary

Histologic Percentage of Vital Bone Formation

Histologic percentage of vital bone formation in bone cores

Time frame: 18-20 weeks after grafting

ArmMeasureValue (MEDIAN)
Cancellous FDBA (LifeNet)Histologic Percentage of Vital Bone Formation12.98 percentage of vital bone
Cortical FDBA (LifeNet)Histologic Percentage of Vital Bone Formation16.08 percentage of vital bone

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026