Comparing two bone graft materials for preserving jawbone after tooth extraction

Prospective Comparative Evaluation of Alveolar Ridge Preservation: Mixing Allograft With Xenograft VS. Allograft Alone in Atraumatic Extraction Sockets

This study is testing which of two bone graft materials works better to keep the jawbone strong after a tooth is pulled, helping people get ready for future dental implants.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Maryland, Baltimore (other)
• Locations: 1 site (Baltimore, Maryland)
• Trial ID: NCT06472453 on ClinicalTrials.gov

What this trial studies

This research compares the effectiveness of two different bone grafting materials in maintaining jawbone integrity following tooth extraction. Participants will be randomly assigned to receive either a mixture of vallos®f (human source bone) and Bio-Oss (animal source bone) or vallos® only. The study aims to evaluate how well these materials preserve the jawbone space necessary for future dental implants. Throughout the study, participants will undergo various assessments, including oral exams, x-rays, and surgical procedures over approximately two years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who need a posterior tooth extraction followed by implant placement.

Not a fit: Patients with insufficient space for an implant or those with uncontrolled periodontal disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve outcomes for patients requiring dental implants by better preserving jawbone structure after tooth extraction.

How similar studies have performed: Other studies have shown promising results with similar bone grafting approaches, indicating potential for success in this study.

Eligibility criteria

Inclusion criteria:

1. Provision of informed consent
2. At least 18 years old
3. In need of one posterior tooth (premolar or molar), excluding third molar molars, planned for extraction and replacement with a dental implant
4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
5. At least one retained natural tooth adjacent to the study site

Exclusion criteria

1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
2. Previous interventions performed involving soft and/or bone grafting in the study site
3. Active treated caries
4. Uncontrolled periodontal disease present
5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
8. Self-reported use of smokeless tobacco or e-cigarette
9. Self-reported history of current alcohol or drug abuse
10. Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c \> 8.0 within last six-month
11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration

Where this trial is running

Baltimore, Maryland

• University of Maryland School of Dentistry — Baltimore, Maryland, United States (RECRUITING)

Study contacts

• Study coordinator: Hanae Saito, DDS, MS, CCRC

Conditions: Alveolar Ridge Augmentation