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

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®.

Study Overview

• Status: Completed
• Conditions: Partial Edentulism
• Intervention / Treatment: Device: Bio-Oss®; Device: Salvin-Oss®

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado School of Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Bio-Oss®; 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).	Device: Bio-Oss®; Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.
ACTIVE_COMPARATOR: Salvin-Oss®; 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).	Device: Salvin-Oss®; Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Kerri Font, DDS, MS, University of Colorado, Denver; Principal Investigator: Charles A Powell, DDS, MS, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 22, 2019
• Primary Completion (ACTUAL): March 15, 2021
• Study Completion (ACTUAL): March 15, 2021

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (ACTUAL): December 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 13, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: toothlessness
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Antioxidants; Salvin
• Other Study ID Numbers: 18-1722

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes