Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts

Partial Edentulism Clinical Trial

Official title:

Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03769376
• Other study ID #: 18-1722
• Status: Completed
• Phase: N/A
• Start date: May 22, 2019
• Est. completion date: March 15, 2021

Study information

• Verified date: December 2021
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the speed of bone healing of the two most commonly used xenografts on the market, Bio-Oss® and Salvin-Oss® using a tooth extraction ridge preservation model in participants scheduled for tooth extraction and subsequent receipt of a dental implant. Researchers hypothesize that there will be additional vital bone at 16-20 weeks with Salvin-Oss®.

Description:

This study focuses on xenografts to preserve alveolar bone after tooth extraction prior to placement of a dental implant. Extraction sites that are not grafted for ridge preservation may lose up to 50 percent of their ridge width the first year after extraction. Xenografts are one of several products on the market used to maintain ridge width after tooth extraction. This study aims to compare the two most commonly used, FDA-approved xenografts on the market, Bio-Oss® and Salvin-Oss, in the preservation of alveolar bone after extraction of non-molar teeth.

The primary objective of this study is to histologically evaluate and compare the percentage of new bone formation in healing extraction sockets of non-molar teeth grafted with Bio-Oss® versus Salvin-Oss®. The secondary aim is to observe clinical changes in ridge height and ridge width after grafting with these two materials.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: March 15, 2021
• Est. primary completion date: March 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• At least 18 years of age.

• Consent to be in the study.

• Planned for non-emergent dental treatment.

• American Society of Anesthesiologist Class I or II.

• Require extraction of a single-rooted non-molar tooth.

• Committed to have the dental implant placed at the site of extraction 16-20 weeks after extraction and ridge preservation.

• Adequate restorative space for implant-retained restoration.

• > 10mm alveolar bone height without impingement on the maxillary sinus or inferior alveolar canal.

• Root location and angulation that would be consistent with the subsequent implant placement.

• Roots with minimum of 10mm of radiographic bone support.

• Root angulation similar to the angulation of the implant to be placed at the site.

Exclusion Criteria:

• < 18 years old.

• Currently pregnant.

• Require antibiotic prophylaxis prior to dental procedures as outlined by the 2017 American Heart Association guidelines.

• Decisionally challenged individuals.

• Current smokers.

• American Society of Anesthesiologist Class III or IV.

Related Conditions & MeSH terms

• Partial Edentulism

Intervention

Device:
• Bio-Oss®
Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.
• Salvin-Oss®
Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.

Locations

Country	Name	City	State
United States	University of Colorado School of Dental Medicine	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks	The amount of new bone formation at the tooth extraction/xenograft site as measured by the percent of vital bone, residual graft, and connective tissue observed in a histological sample (a bone biopsy) obtained at the time of dental implant insertion, 16-20 weeks after extraction.	Baseline to 16-20 weeks
Primary	New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks	The boney ridge height on both the buccal/lingual and width in area of the extraction/xenograft site as measured at time of implant placement with an intra-oral dental probe at 16-20 weeks after extraction. Percent change in ridge width from baseline is reported	Baseline to 16-20 weeks