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

Study Overview
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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.

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.

Official Title
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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

Conditions
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Dental Extraction, Wound Heal

Intervention / Treatment
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* Device: Vallos
* Device: Vallomix
* Device: Vallos-F
* Device: Vallomix-F


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 4 arm randomized controlled parallel study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 Vallos<br>Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. | Device: Vallos<br>* Demineralized freeze-dried bone allograft (DFBA) in a small particle form<br>* Other names: DFDBA particulate;|
| Active Comparator: Group 2 Vallomix<br>Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. | Device: Vallomix<br>* A combination of cow-derived xenograft and human-derived DFDBA particulate<br>* Other names: Xenograft and human-derived DFDBA;|
| Active Comparator: Group 3 Vallos-F<br>Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. | Device: Vallos-F<br>* Demineralized freeze-dried bone allograft (DFDBA) in a fiber form<br>* Other names: DFDBA in fiber form;|
| Active Comparator: Group 4 Vallomix-F<br>Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction. | Device: Vallomix-F<br>* A combination of cow-derived xenograft and human-derived DFDBA fibers<br>* Other names: Xenograft (Bio-Oss) combined with DFDBA fibers;|

What is the study measuring?
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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 | 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 | Wound healing time ( approximately 18 to 20 weeks) | 
| Percentage of connective tissue | Measure of percentage of connective tissue (fibrous tissue and marrow space) at time of implant. | Wound healing time ( approximately 18 to 20 weeks) | 
| Change in ridge width | Measure of change in ridge width from extraction to healing time | Baseline to 18-20 weeks | 
| Change in buccal ridge height | Measure of change in buccal ridge height from extraction to healing time | Baseline to 18-20 weeks | 
| Change in lingual ridge height | Measure of change in lingual ridge height from extraction to healing time | Baseline to 18-20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ridge preservation, Implant