Bone Graft Materials for Wound Healing After Tooth Extraction

Overseen By Brian Mealey, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Chemotherapy, Immunosuppressants, Bisphosphonates, Steroids

Disqualifiers: Pregnancy, Poorly controlled diabetes, Autoimmune diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

102 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.

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

Eligibility Criteria

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

My tooth socket's bone wall is partially broken but not more than half.

I have enough jawbone height for dental implants without affecting my sinus or nerve canal.

I am a woman who cannot become pregnant due to surgery or menopause.

Exclusion Criteria

Will not cooperate with the follow-up schedule

My jawbone is not suitable for dental implants.

If I become pregnant during the study, I will be withdrawn.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

1 day

1 visit (in-person)

Healing

Participants undergo a healing period following ridge preservation, during which they are monitored as needed per standard care

18-20 weeks

Follow-up visits as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment, including core biopsy evaluation and measurement of clinical outcomes

4 weeks

Treatment Details

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.

Participant Groups

Group I: Group 1 Vallos (DCP) Active Control 1 Intervention

Subjects will be randomized into this group and receive DFDBA particulate alone

Group II: Group 2 Vallomix (DCF) Active Control 1 Intervention

Subjects will be randomized into this group and receive DFDBA fibers alone

Group III: Group 3 Vallos-F (DPX) Active Control 1 Intervention

Subjects will be randomized into this group and receive Xenograft combined with DCP

Group IV: Group 4 Vallomix-F (DFX) Active Control 1 Intervention

Subjects will be randomized into this group and receive Xenograft combined with DCF.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+