Clinical trial NCT05400213: Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Extraction
Wound Heal
Keywords: Ridge preservation
Implant
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 arm randomized controlled parallel study
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage vital bone formation
timeFrame: Wound healing time ( approximately 18 to 20 weeks)
Secondary outcomes:
measure: Percentage of residual graft material
timeFrame: Wound healing time ( approximately 18 to 20 weeks)
measure: Percentage of connective tissue
timeFrame: Wound healing time ( approximately 18 to 20 weeks)
measure: Change in ridge width
timeFrame: Baseline to 18-20 weeks
measure: Change in buccal ridge height
timeFrame: Baseline to 18-20 weeks
measure: Change in lingual ridge height
timeFrame: Baseline to 18-20 weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio (Dental School)
state: Texas
Study officials:
affiliation: University of Texas Health Science Center San Antonio
name: Brian Mealey, DDS, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Texas Health Science Center San Antonio
name: Angela Palaiologou-Gallis, DDS
role: PRINCIPAL_INVESTIGATOR
References: