Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft

NCT05400213 | Completed Results FDA Device

• 1 other identifier: HSC20220346H
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.

Conditions

Dental Extraction; Wound Heal

Keywords

Ridge preservation; Implant

Outcome Measures

Primary Outcomes (1)

• Percentage Vital Bone Formation

  Measure of percentage of vital bone formation from extraction to time of implant, this is a measure of how much bone has regenerated since the extraction to the surgery.

  Wound healing time ( approximately 18 to 20 weeks)

Secondary Outcomes (5)

• Percentage of Residual Graft Material

  Wound healing time ( approximately 18 to 20 weeks)

• Percentage of Connective Tissue at Time of Implant

  Baseline to 18-20 weeks

• Change in Ridge Width (Clinical Measurement)

  Baseline to 18-20 weeks

• Change in Buccal Ridge Height (Clinical Measurement)

  Baseline to 18-20 weeks

• Change in Lingual Ridge Height (Clinical Measurement)

  Baseline to 18-20 weeks

Study Arms (4)

Group 1 Vallos (DCP)

ACTIVE COMPARATOR

Subjects will be randomized into this group and receive DFDBA particulate alone

Device: Vallos (DCP)

Group 2 Vallomix (DCF)

ACTIVE COMPARATOR

Subjects will be randomized into this group and receive DFDBA fibers alone

Device: Vallomix (DCF)

Group 3 Vallos-F (DPX)

ACTIVE COMPARATOR

Subjects will be randomized into this group and receive Xenograft combined with DCP

Device: Vallos-F (DPX)

Group 4 Vallomix-F (DFX)

ACTIVE COMPARATOR

Subjects will be randomized into this group and receive Xenograft combined with DCF.

Device: Vallomix-F (DFX)

Interventions

Vallos (DCP) DEVICE

Demineralized freeze-dried bone allograft (DFBA) in a small particle form

Also known as: DFDBA particulate

Group 1 Vallos (DCP)

Vallomix (DCF) DEVICE

A combination of cow-derived xenograft and human-derived DFDBA particulate

Also known as: Xenograft and human-derived DFDBA

Group 2 Vallomix (DCF)

Vallos-F (DPX) DEVICE

Demineralized freeze-dried bone allograft (DFDBA) in a fiber form

Also known as: DFDBA in fiber form

Group 3 Vallos-F (DPX)

Vallomix-F (DFX) DEVICE

A combination of cow-derived xenograft and human-derived DFDBA fibers

Also known as: Xenograft (Bio-Oss) combined with DFDBA fibers

Group 4 Vallomix-F (DFX)

Eligibility Criteria

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

You may qualify if:

• One tooth, excluding molars, that has been identified by dental faculty as requiring a single tooth extraction
• A dental implant is indicated and treatment planned to replace the missing tooth
• Have adequate restorative space for a dental implant-retained restoration
• Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
• Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
• Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
• Are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day

You may not qualify if:

• Will not cooperate with the follow-up schedule.
• Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
• Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over the counter pregnancy test will be provided if pregnancy status is unknown or suspected).
• Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
• 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 (Dental School)

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Foster JE, Coleman CC, Palaiologou AA, Mealey BL. Healing following ridge preservation using demineralized allograft particles or fibers alone, and combined with xenograft. J Periodontol. 2025 Jul 24. doi: 10.1002/jper.11374. Online ahead of print.

  PMID: 40702945 DERIVED

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Brian Mealeey, DDS, MS
• Organization: University of Texas Health Science Center at San Antonio

mealey@uthscsa.edu

210-450-8736

Study Officials

• Brian Mealey, DDS, MS

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

• Angela Palaiologou-Gallis, DDS

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Since the outcome of the study is the histologic healing, blinding of the surgeon is not necessary. Blinding is performed only for histomorphometric measurements. The person doing histomorphometric analysis is blinded as to study group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 4 arm randomized controlled parallel study

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: August 2, 2022
• Primary Completion: August 23, 2024
• Study Completion: December 18, 2024
• Last Updated: June 19, 2025
• Results First Posted: June 19, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After study completion and after data are analyzed.

Locations

US (1)