Comparing two types of grafts for preserving alveolar bone after tooth extraction

Ridge Preservation Comparing the Clinical and Histologic Healing of Two Different Putty Bone Grafts

This study is testing two different types of grafts to see which one better helps preserve bone after a tooth is taken out.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Louisville (Academic / other)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Louisville, Kentucky)
• Trial ID: NCT05484492 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the clinical and histologic outcomes of two different graft materials used in socket preservation procedures after tooth extraction. Thirty participants will be divided into two groups, with one group receiving a combination demineralized/mineralized putty allograft and the other receiving a synthetic calcium phosphosilicate putty alloplast graft, both covered with a regenerative tissue matrix membrane. Clinical measurements will be taken before and four months after the procedure to assess the effectiveness of each graft type. A trephine core will be collected from the grafted site for histologic analysis prior to implant placement.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 and older who require extraction of a non-molar tooth that will be replaced by a dental implant.

Not a fit: Patients with significant systemic diseases affecting the periodontium or those with a history of osteonecrosis of the jaws may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve outcomes for patients undergoing dental implant procedures by identifying the most effective graft material for alveolar ridge preservation.

How similar studies have performed: Previous studies have shown varying success with different graft materials in similar procedures, but this specific comparison is novel.

Eligibility criteria

Inclusion Criteria:

1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant.

   The site must be bordered by at least one tooth.
2. Healthy male or female who is at least 18 years old.
3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee.

Exclusion Criteria:

1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium.
2. Presence or history of osteonecrosis of jaws.
3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration.
4. Patients who have been treated with oral bisphosphonates for more than three years.
5. Patients with an allergy to any material or medication used in the study.
6. Patients who need prophylactic antibiotics
7. Previous head and neck radiation therapy.
8. Chemotherapy in the previous 12 months.
9. Patients on long term NSAID or steroid therapy.
10. Pregnant patients.

Where this trial is running

Louisville, Kentucky

• University of Louisville — Louisville, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: Bindu Dukka, BDS,MSD,MPH — Director, Graduate Periodontics, University of Louisville
• Study coordinator: Bindu Dukka, BDS,MSD,MPH

Conditions Alveolar Bone Resorption; Alveolar ridge preservation; Socket preservation