NCT04550689

Comparison of Dimensional Changes After Tooth Extractions Between Xenograft and Allograft

A Pilot RCT Study Comparing Dimensional Alterations After Socket Grafting With Xenograft Versus Allograft

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft.

Detailed description

AIM To compare dimensional changes in extraction socket of single rooted teeth, 6 months post extraction, when grafted with xenograft versus allograft. PRIMARY OBJECTIVE Horizontal and vertical dimensional changes of extraction sockets as evaluated in a CBCT scan immediately post extraction and 6 months post extraction when grafted with xenograft versus allograft. SECONDARY OBJECTIVE 1. Difference in horizontal dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction. 2. Difference in vertical dimensional changes in xenograft and allograft groups as measured intra-operatively after extraction and at re- entry 6 months post extraction. 3. Difference in histologic analysis of bone biopsy cores taken in xenograft and allograft groups at 6 months re-entry from osteotomy site. Difference in newly regenerated supracrestal bone height and volume will be measured directly from the segmented images from MicroCT. NULL HYPOTHESIS There is no difference between the two groups for any of the parameters evaluated.

Conditions

• Tooth Loss

Interventions

Type	Name	Description
DEVICE	Bone graft	Bone grafts produced by Straumann LLC

Timeline

• Start date: 2020-10-01
• Primary completion: 2023-06-30
• Completion: 2024-06-30
• First posted: 2020-09-16
• Last updated: 2023-11-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study