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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2024-12-18

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Extraction Wound Heal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 arm randomized controlled parallel study

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Group 1 Vallos (DCP)

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

Group Type ACTIVE_COMPARATOR

Vallos (DCP)

Intervention Type DEVICE

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

Group 2 Vallomix (DCF)

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

Group Type ACTIVE_COMPARATOR

Vallomix (DCF)

Intervention Type DEVICE

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

Group 3 Vallos-F (DPX)

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

Group Type ACTIVE_COMPARATOR

Vallos-F (DPX)

Intervention Type DEVICE

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

Group 4 Vallomix-F (DFX)

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

Group Type ACTIVE_COMPARATOR

Vallomix-F (DFX)

Intervention Type DEVICE

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

Interventions

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Vallos (DCP)

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

Intervention Type DEVICE

Vallomix (DCF)

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

Intervention Type DEVICE

Vallos-F (DPX)

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

Intervention Type DEVICE

Vallomix-F (DFX)

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

Intervention Type DEVICE

Other Intervention Names

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DFDBA particulate Xenograft and human-derived DFDBA DFDBA in fiber form Xenograft (Bio-Oss) combined with DFDBA fibers

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes