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

Randomized Controlled Trial of Wound Healing Following Tooth Extraction and Ridge Preservation Using Decalcified Freeze-dried Bone Allograft (DFDBA) Alone in Particulate Fiber Form and in Combination With Xenograft

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.

Study Overview

• Status: Completed
• Conditions: Wound Heal; Dental Extraction
• Intervention / Treatment: Device: Vallos (DCP); Device: Vallomix (DCF); Device: Vallos-F (DPX); Device: Vallomix-F (DFX)

Detailed Description

The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % "CT/other" (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center at San Antonio (Dental School)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy; Positive medical history of endocarditis following oral or dental surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1 Vallos (DCP); Subjects will be randomized into this group and receive DFDBA particulate alone	Device: Vallos (DCP); Demineralized freeze-dried bone allograft (DFBA) in a small particle form; Other Names: DFDBA particulate
Active Comparator: Group 2 Vallomix (DCF); Subjects will be randomized into this group and receive DFDBA fibers alone	Device: Vallomix (DCF); A combination of cow-derived xenograft and human-derived DFDBA particulate; Other Names: Xenograft and human-derived DFDBA
Active Comparator: Group 3 Vallos-F (DPX); Subjects will be randomized into this group and receive Xenograft combined with DCP	Device: Vallos-F (DPX); Demineralized freeze-dried bone allograft (DFDBA) in a fiber form; Other Names: DFDBA in fiber form
Active Comparator: Group 4 Vallomix-F (DFX); Subjects will be randomized into this group and receive Xenograft combined with DCF.	Device: Vallomix-F (DFX); A combination of cow-derived xenograft and human-derived DFDBA fibers; Other Names: Xenograft (Bio-Oss) combined with DFDBA fibers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Residual Graft Material	Measure of percentage of residual graft material remaining at time of implant, this is the amount of graft material remaining from the original amount implanted during surgery.	Wound healing time ( approximately 18 to 20 weeks)
Percentage of Connective Tissue at Time of Implant	Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. This is the amount of connective tissue that is present at the time of surgery.	Baseline to 18-20 weeks
Change in Ridge Width (Clinical Measurement)	Measure of change in ridge width from extraction to healing time	Baseline to 18-20 weeks
Change in Buccal Ridge Height (Clinical Measurement)	Measure of change in buccal ridge height from extraction to healing time	Baseline to 18-20 weeks
Change in Lingual Ridge Height (Clinical Measurement)	Measure of change in lingual ridge height from extraction to healing time	Baseline to 18-20 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Actual): August 23, 2024
• Study Completion (Actual): December 18, 2024

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: May 26, 2022
• First Posted (Actual): June 1, 2022

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 17, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Implant; Ridge preservation
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: HSC20220346H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data will be shared as summary results on ClinicalTrials.gov and in a peer-review journal.
• IPD Sharing Time Frame: After study completion and after data are analyzed.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes