Ridge Preservation With FDBA (Freeze Dried Bone Allograft) Using Dexamethasone vs. Saline

Launched by THE UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER AT SAN ANTONIO · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called "Ridge Preservation," which is done after a tooth extraction to help maintain the bone in the area where the tooth used to be. The trial specifically looks at the effectiveness of a bone graft made from human tissue that has been dried and then rehydrated using two different solutions: dexamethasone (a type of medication) and saline (sterile salt water). The goal is to see if using dexamethasone as the rehydrating solution can improve the healing of the bone compared to using saline.

To participate in this trial, you need to be between 18 and 89 years old and have one non-molar tooth that needs to be removed, with plans for a dental implant to replace it. You should also have enough bone height in the area to support the implant and not have any serious health issues that could affect healing. If you decide to join, you will receive the standard care for your tooth extraction and bone graft, with additional monitoring to track your healing process. It's important to know that certain individuals, such as pregnant women or those who smoke heavily, cannot participate in the trial.

Gender

ALL

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.