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

Wound Heal Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05400213
• Other study ID #: HSC20220346H
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: March 31, 2025

Study information

• Verified date: May 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: Brian Mealey, DDS, MS
• Phone: 210-567-3589
• Email: mealey[@]uthscsa.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 xenograft and DFDBA fibers.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Extraction
• Wound Heal
• Wounds and Injuries

Intervention

Device:
• Vallos
Demineralized freeze-dried bone allograft (DFBA) in a small particle form
• Vallomix
A combination of cow-derived xenograft and human-derived DFDBA particulate
• Vallos-F
Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
• Vallomix-F
A combination of cow-derived xenograft and human-derived DFDBA fibers

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at San Antonio (Dental School)	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Change in ridge width	Measure of change in ridge width from extraction to healing time	Baseline to 18-20 weeks
Secondary	Change in buccal ridge height	Measure of change in buccal ridge height from extraction to healing time	Baseline to 18-20 weeks
Secondary	Change in lingual ridge height	Measure of change in lingual ridge height from extraction to healing time	Baseline to 18-20 weeks