Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation

Bone Loss in Jaw Clinical Trial

Official title:

Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation: A Double Arm Randomized Control And Histomorphometric Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06173791
• Other study ID #: HSC20230387H
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: May 2026

Study information

• Verified date: December 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Angela Palaiologou-Gallis, DDS, MS
• Phone: 210-567-3567
• Email: PalaiologouA[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM.

The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.

Description:

This entire protocol involves procedures that are standard care and will randomize subjects to of one two routine care procedures. Patients needing maxillary sinus augmentation will be enrolled. There will be two subject groups in this study both of which will randomized to one of two standard care procedures. No risk or benefit is expected from being assigned to either group as both procedures are both standard care. In both groups a bone sample (core) will be obtained as a by-product of implant placement. Bone will not be extracted solely for research purposes, the bone sample attained for research will only be from bone left over after the SOC implant placement.

Allocation of subjects into test group or control group will be based on numbers drawn from a stack of sealed envelopes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 26
• Est. completion date: May 2026
• Est. primary completion date: May 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

• Patients between age 18 and 89

• Patients needing sinus augmentation to support implant placement in the posterior maxilla

• Patients must be nonsmokers, former smokers, or current smokers who smoke <10 cigarettes per day, by self-report

• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.

Exclusion Criteria:

• Patients who disclose that they will not be able to cooperate with the follow-up schedule.

• Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)

• Pregnant women or women intending to become pregnant during study period

• Smokers who smoke > 10 cigarettes per day

Related Conditions & MeSH terms

• Bone Loss in Jaw

Intervention

Device:
• DFDBA fibers
Bone Allograft fibers used in dental sinus reconstruction surgery
• DFDBA particles
Bone Allograft particles used in dental sinus reconstruction surgery
• DBBM
DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Vital Bone Formation	Each side of the maxillary sinus will be used as a separate unit of analysis. The assumption is that each patient will have only one side of the maxillary sinus; however, it is common for some patients to need both maxillary sinuses augmented (2 sites in a single patient). Change in vital bone formation will be measured from baseline (surgery) to 6 months post surgery.	Baseline to 6 months