Comparing bone healing with dexamethasone vs saline after tooth extraction
Histologic Evaluation of Wound Healing After Ridge Preservation Using Allograft Hydrated With Dexamethasone Versus Saline
This study is testing whether using dexamethasone or saline to hydrate a bone graft after tooth extraction helps people heal better before getting a dental implant.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 89 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center at San Antonio Academic / other |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06556095 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of hydrating a bone allograft with dexamethasone compared to normal saline after tooth extraction. Participants will receive a bone graft in the socket to preserve the ridge, and the healing process will be monitored over approximately 16 weeks. The primary goal is to assess the amount of new bone formation in the socket before placing a dental implant. The bone retrieved during the implant placement will be analyzed to determine the effectiveness of the different hydration solutions.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 89 requiring a single tooth extraction and subsequent dental implant.
Not a fit: Patients with allergies to dexamethasone or those who cannot comply with follow-up schedules may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance bone healing and improve outcomes for dental implant procedures.
How similar studies have performed: While the use of bone allografts is common, the specific comparison of dexamethasone versus saline for this purpose is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
San Antonio, Texas
- UT Health Science Center at San Antonio, School of Dentistry — San Antonio, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Brian L Mealey, DDS, MS — The University of Texas Health Science Center at San Antonio
- Study coordinator: Brian L Mealey, DDS, MS
- Email: mealey@uthscsa.edu
- Phone: 210-567-3589
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.