Bone Graft Materials for Wound Healing After Tooth Extraction

Overseen By Brian Mealey, DDS, MS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

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

No Placebo Group

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If I become pregnant during the study, I will be withdrawn.

Treatment Details

Interventions

• Ridge Preservation (Bone Graft)
• Vallomix (Device)
• Vallomix-F (Device)
• Vallos (Device)
• Vallos-F (Device)

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 3 Vallos-F Active Control 1 Intervention

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Group II: Group 1 Vallos Active Control 1 Intervention

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Group III: Group 2 Vallomix Active Control 1 Intervention

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Group IV: Group 4 Vallomix-F Active Control 1 Intervention

Subjects will be randomized into one of the four groups and receive the corresponding material for ridge preservation following tooth extraction.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+