Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation

NCT06173791 | Completed FDA Device

• 1 other identifier: HSC20230387H
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bone Loss in Jaw

Keywords

Tooth loss; Bone Resorption; Xenograft; Allograft

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

DFDBA Fibers with DBBM

ACTIVE COMPARATOR

After standard of care elevation of the Schneiderian membrane, a mix of DFDBA fibers with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.

Device: DFDBA fibers; Device: DBBM

DFDBA Particles with DBBM

OTHER

After standard of care elevation of the Schneiderian membrane, a mix of DFDBA particles with DBBM (50%-50%) will be introduced in the space created between the Schneiderian membrane and the alveolar crest of the maxilla.

Device: DFDBA particles; Device: DBBM

Interventions

DFDBA fibers DEVICE

Bone Allograft fibers used in dental sinus reconstruction surgery

Also known as: Demineralized Freeze Dried Bone Allograft Fibers

DFDBA Fibers with DBBM

DFDBA particles DEVICE

Bone Allograft particles used in dental sinus reconstruction surgery

Also known as: Demineralized Freeze Dried Bone Allograft Particles

DFDBA Particles with DBBM

DBBM DEVICE

DBBM is routinely used in sinus augmentation to support dental implant placement and restoration of missing teeth.

Also known as: Deproteinized Bovine Bone Mineral

DFDBA Fibers with DBBM; DFDBA Particles with DBBM

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Tooth Loss; Bone Resorption

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Angela Palaiologou-Gallis, DDS, MS

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only investigators will know which material was used for the sinus lift.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Program Director, Graduate Periodontics

Model Details: This is a two-independent arm, parallel-design randomized, prospective trial designed to compare two standard of care techniques

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 18, 2023
• Study Start: September 25, 2023
• Primary Completion: February 10, 2026
• Study Completion: February 10, 2026
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: When summary data are published or otherwise made available

Locations

US (1)