Clinical trial NCT06556095: Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline
Official title: Histologic Evaluation of Wound Healing After Ridge Preservation Using Allograft Hydrated With Dexamethasone Versus Saline
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Bone Graft
Tooth Extraction
Keywords: Allograft
Ridge preservation
Dexamethasone
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial examining wound healing after tooth extraction and ridge preservation.
Primary purpose: TREATMENT

Brief summary: Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation, including bone allografts (bone grafts derived from a human tissue donor). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.

Detailed description: In this study, the investigators are examining if there is any difference in new bone formation in the tooth socket when the bone allograft placed after tooth extraction is hydrated with a solution of dexamethasone rather than normal saline. Dexamethasone is a steroid that is used routinely in medicine and dentistry as an inflammatory medication which can decrease things like swelling or pain. In this study, after removing the tooth the bone allograft will be hydrated in either saline or dexamethasone solution and then placed into the socket. After healing, a dental implant will later be placed at the same site. The graft material is used as part of standard care in dental practices, but it is not clear if the healing following use of allograft hydrated in dexamethasone is similar or different to hydrating with saline.

At the end of this study the researchers hope to learn the following: How much new bone formation occurs inside the tooth socket at approximately 16 weeks of healing after ridge preservation with allograft hydrated in either saline or dexamethasone solution?

This will be done by examining the bone retrieved from the implant site during the placement of the implant at study visit #5. This bone is normally removed during the drilling of the implant site and discarded as part of standard care. As part of this study, the bone specimen will be removed as normal but will not be discarded; instead, it will be analyzed for the purpose of this research study.

Eligibility criteria: Inclusion Criteria:

* Male or female patient aged 18 to 89
* 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
* Site has adequate restorative space for a dental implant-retained restoration
* Site has at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
* Site has 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.
* Patients are nonsmokers or former smokers. Current smokers may be included if they smoke \<10 cigarettes per day

Exclusion Criteria:

* Patient allergic to dexamethasone
* 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.

Primary outcomes:
measure: Percentage of Bone Formation
timeFrame: Baseline to 16 weeks (±2 weeks)
Secondary outcomes:
measure: Ridge Width
timeFrame: Baseline to 16 weeks (±2 weeks)
measure: Buccal Ridge Height
timeFrame: Baseline to 16 weeks (±2 weeks)
measure: Lingual Ridge Height
timeFrame: Baseline to 16 weeks (±2 weeks)
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: UT Health Science Center at San Antonio, School of Dentistry
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at San Antonio
name: Brian L Mealey, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References: