NCT03149172

Comparison of Post Tooth Extraction Healing Using Different Xenograft Materials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Tufts University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this pilot study is to conduct a interventional prospective clinical trial to evaluate the efficacy of three different xenografts for ridge preservation by comparing the quality of newly formed bone using histomorphometric and micro CT analysis.The three xenograft materials under investigation are Bio-Oss® (bovine derived xenograft), Equimatrix® (equine derived xenograft), and Endobon® (bovine derived xenograft). There are no prospective studies comparing the effectiveness of these three materials, Bio-Oss®, Endobon® and Equimatrix®, when placed in extraction sockets. Participants will be recruited from patients in the TUSDM clinics that require extraction of single rooted non-molar tooth and are treatment planned to receive dental implants in the future. Participants will be randomized to receive one of the three xenograft materials after tooth extraction. The percentage of newly formed bone and bone density will be compared between the three materials 4-6 months after ridge preservation.

Detailed description

This is a pilot prospective clinical trial in which histological and micro CT analysis will be utilized to compare between Endobon®, Equimatrix®, and Bio-Oss®. Primary aim: Compare the percentage of newly formed bone between Equimatrix®, Bio-Oss® and Endobon®. The investigators hypothesize that the mean percentage of newly formed bone from Equimatrix® will be higher than Bio-Oss® and/or Endobon®. Secondary aim: Compare the bone density between Equimatrix®, Bio-Oss® and Endobon®. The investigators hypothesize that the bone density from Equimatrix® will be higher than Bio-Oss® and/or Endobon®.

Conditions

• Alveolar Bone Loss

Interventions

Type	Name	Description
DEVICE	Equimatrix®	Ridge preservation bone grafting after tooth extraction
DEVICE	Bio-Oss®	Ridge preservation bone grafting after tooth extraction
DEVICE	Endobon®	Ridge preservation bone grafting after tooth extraction

Timeline

• Start date: 2014-10-20
• Primary completion: 2016-06-07
• Completion: 2016-12-07
• First posted: 2017-05-11
• Last updated: 2020-09-25
• Results posted: 2020-09-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study