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Dental ExtractionNCT05400213

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

A study testing Vallos (DCP), Vallomix (DCF) and Vallos-F (DPX) in people with Dental Extraction and Wound Heal, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Dental Extraction, Wound Heal
What is being tested?
Vallos (DCP), Vallomix (DCF) and Vallos-F (DPX)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteUnited States
Study dates
2 Aug 2022to 18 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas Health Science Center at San Antonio (Dental School)

    San Antonio, Texas, 78229

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Vallos (DCP), Vallomix (DCF), Vallos-F (DPX), Vallomix-F (DFX)
Keywords
Ridge preservation, Implant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vallos (DCP)Device

    Also called DFDBA particulate

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

  • Vallomix (DCF)Device

    Also called Xenograft and human-derived DFDBA

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

  • Vallos-F (DPX)Device

    Also called DFDBA in fiber form

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

  • Vallomix-F (DFX)Device

    Also called Xenograft (Bio-Oss) combined with DFDBA fibers

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

Study groups in NCT05400213
Study groupRoleWhat they receive
Group 1 Vallos (DCP)Active comparatorSubjects will be randomized into this group and receive DFDBA particulate alone
Receives: Device: Vallos (DCP)
Group 2 Vallomix (DCF)Active comparatorSubjects will be randomized into this group and receive DFDBA fibers alone
Receives: Device: Vallomix (DCF)
Group 3 Vallos-F (DPX)Active comparatorSubjects will be randomized into this group and receive Xenograft combined with DCP
Receives: Device: Vallos-F (DPX)
Group 4 Vallomix-F (DFX)Active comparatorSubjects will be randomized into this group and receive Xenograft combined with DCF.
Receives: Device: Vallomix-F (DFX)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Wound healing time ( approximately 18 to 20 weeks)

Secondary outcomes (5)

  1. 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.

    Measured: Wound healing time ( approximately 18 to 20 weeks)

  2. 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.

    Measured: Baseline to 18-20 weeks

  3. Change in Ridge Width (Clinical Measurement)

    Measure of change in ridge width from extraction to healing time

    Measured: Baseline to 18-20 weeks

  4. Change in Buccal Ridge Height (Clinical Measurement)

    Measure of change in buccal ridge height from extraction to healing time

    Measured: Baseline to 18-20 weeks

  5. Change in Lingual Ridge Height (Clinical Measurement)

    Measure of change in lingual ridge height from extraction to healing time

    Measured: Baseline to 18-20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2022
  2. Study start2 Aug 2022
  3. Primary completion23 Aug 2024
  4. Study completion18 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
4 arm randomized controlled parallel study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05400213
Sponsor's protocol ID
HSC20220346H
Status last verified
Jun 2025
First submitted
26 May 2022
Last updated
19 Jun 2025
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: De-identified data will be shared as summary results on ClinicalTrials.gov and in a peer-review journal.

Publications

  • Yineman KJ, Palaiologou AA, Powell CA, Deas DE, Mealey BL. Palatal donor site wound healing following mucogingival surgery using amnion-chorion membrane: A randomized controlled clinical trial. J Periodontol. 2026 Jun 18. doi: 10.1002/jper.70147. Online ahead of print.

    PubMed 42312399

  • 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. 2026 Jan;97(1):23-33. doi: 10.1002/jper.11374. Epub 2025 Jul 24.

    PubMed 40702945

Questions about this trial

What is this clinical trial studying?

A study testing Vallos (DCP), Vallomix (DCF) and Vallos-F (DPX) in people with Dental Extraction and Wound Heal, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Vital Bone Formation (time frame: Wound healing time ( approximately 18 to 20 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05400213, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2025.

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