Bone Graft Materials for Wound Healing After Tooth Extraction
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores different materials used to aid bone healing after tooth extraction, particularly for those planning a dental implant. Researchers aim to assess how well these materials promote new bone growth and how much material remains after a few months. The study includes four groups, each testing a different combination of bone graft materials, including Ridge Preservation. Suitable candidates have a single tooth, not a molar, needing extraction and plan to replace it with an implant. Those with sufficient existing bone and space for the implant, who are nonsmokers or light smokers, are especially encouraged to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative dental research and potentially benefit from advanced treatment options.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect bone healing, like long-term steroids or bisphosphonates, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that the treatments tested for healing after tooth removal are generally safe. For the treatment using DFDBA particles (Group 1 Vallos), one study found only one case of significant bleeding after surgery, indicating that serious problems are rare.
For DFDBA fibers alone (Group 2 Vallomix), studies have shown minimal risks, usually limited to minor discomfort from the tooth removal process. This suggests the treatment is generally well-tolerated.
When DFDBA combines with another material (Group 3 Vallos-F and Group 4 Vallomix-F), evidence suggests similar safety levels as the other treatments, with no significant increase in problems when these materials are used together.
Overall, the treatments in this study have shown safety, with few reports of serious side effects, suggesting a good safety profile for those considering joining the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these bone graft treatments for wound healing after tooth extraction because they offer unique approaches to ridge preservation. Unlike traditional methods using autografts or allografts, Group 1 Vallos (DCP) and Group 2 Vallomix (DCF) involve the use of DFDBA, but in different forms—particulates and fibers, respectively. Group 3 Vallos-F (DPX) and Group 4 Vallomix-F (DFX) combine xenografts with DFDBA components, potentially enhancing the healing process by integrating the benefits of both synthetic and natural materials. These innovative combinations might accelerate healing and improve bone regeneration, offering promising alternatives to existing options.
What evidence suggests that this trial's treatments could be effective for wound healing after tooth extraction?
Research has shown that DFDBA, a type of bone graft material, can help maintain bone health after tooth extraction. DFDBA is available in two forms: fiber and particle. In this trial, participants will be randomized into groups to receive these materials. Group 1 will receive DFDBA particulate alone, while Group 2 will receive DFDBA fibers alone. When combined with xenograft (bone material from another species), as in Groups 3 and 4, DFDBA can further enhance bone preservation and healing. Patients who used these materials demonstrated better bone maintenance compared to those who used nothing. These findings suggest that these materials could effectively maintain bone structure and support healing after tooth extractions.678910
Who Is on the Research Team?
Brian L Mealey, DDS, MS
Principal Investigator
University of Texas Health Science Center San Antonio
Angela Palaiologou-Gallis, DDS
Principal Investigator
University of Texas Health Science Center San Antonio
Are You a Good Fit for This Trial?
This trial is for non-pregnant women, including those post-hysterectomy, tubal ligation, or menopause. Participants should be nonsmokers or light smokers (less than 10 cigarettes per day), have a tooth excluding molars needing extraction with enough bone height and space for an implant. Those with active infections other than periodontitis, heavy smokers, certain medical conditions affecting healing, or on specific medications are excluded.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Tooth extraction and ridge preservation using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers
Healing
Participants undergo a healing period following ridge preservation, during which they are monitored as needed per standard care
Follow-up
Participants are monitored for safety and effectiveness after treatment, including core biopsy evaluation and measurement of clinical outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Ridge Preservation
- Vallomix
- Vallomix-F
- Vallos
- Vallos-F
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor