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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Partial Edentulism

Treatments: Device: Salvin-Oss®; Device: Bio-Oss®

Study type: Interventional

Funder types: Other

Identifiers

NCT03769376

18-1722

Details and patient eligibility

About

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®.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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38 participants in 2 patient groups

Bio-Oss®

Active Comparator group

Description:

Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).

Treatment:

Device: Bio-Oss®

Salvin-Oss®

Active Comparator group

Description:

Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. Half of participants will be randomly assigned to this treatment group (1:1).

Treatment:

Device: Salvin-Oss®