Status:
ACTIVE_NOT_RECRUITING
Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Conditions:
Bone Graft
Tooth Extraction
Eligibility:
All Genders
18-89 years
Phase:
EARLY_PHASE1
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 bon...
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...
Eligibility Criteria
Inclusion
- 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
- 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 Patients who become pregnant during the study will be withdrawn and standard care will be delivered.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.
Key Trial Info
Start Date :
September 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06556095
Start Date
September 16 2024
End Date
January 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
UT Health Science Center at San Antonio, School of Dentistry
San Antonio, Texas, United States, 78229