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
Trial Overview
The study aims to compare the effectiveness of different graft materials in dental ridge preservation after tooth extraction. It will measure new bone formation using DFDBA fibers alone versus particulate form and combinations with xenograft material over approximately 18-20 weeks.
How Is the Trial Designed?
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Treatment groups
Active Control
Subjects will be randomized into this group and receive DFDBA particulate alone
Subjects will be randomized into this group and receive DFDBA fibers alone
Subjects will be randomized into this group and receive Xenograft combined with DCP
Subjects will be randomized into this group and receive Xenograft combined with DCF.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Citations
Healing following ridge preservation using demineralized ...
This study collected histologic wound healing data on human bone graft materials in a fiber and particle form alone and in combination with a ...
Healing following ridge preservation using demineralized ...
This study collected histologic wound healing data on human bone graft materials in a fiber and particle form alone and in combination with a ...
Post Extraction Changes After Ridge Preservation Using ...
This study aims to evaluate clinical, radiographic and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized ...
4.
withpower.com
withpower.com/trial/bone-graft-materials-for-wound-healing-after-tooth-extraction-9e462Bone Graft Materials for Wound Healing After Tooth ...
Trial Overview The study aims to compare the effectiveness of different graft materials in dental ridge preservation after tooth extraction. It will measure new ...
Healing following ridge preservation using demineralized ...
The purpose of this research was to evaluate healing after alveolar ridge preservation using one of four bone grafting materials: DFDBA alone in ...
NCT06472453 | Vallomix Socket Preservation Study
Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the ...
Vallomix Socket Preservation Study (NCT06472453)
This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction ...
The efficiency of two different synthetic bone graft materials ...
Conclusion: The PLGA graft demonstrated adequate safety and efficacy in dental socket preservation following tooth extraction. However, HA/β ...
9.
drugtrialsformoney.com
drugtrialsformoney.com/wound-healing-following-tooth-extraction-and-ridge-preservation-using-dfdba-alone-in-particulate-fiber-form-and-in-combination-with-xenograft/Wound Healing Following Tooth Extraction and Ridge ...
Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft.
Histologic Comparison of Healing After Tooth Extraction ...
... safety ... Few studies (41% of those included) reported data on the incidence of persisting sensory disturbance >1 year following implant surgery.
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