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

NCT03769376 | Completed Results FDA Device

• 1 other identifier: 18-1722
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Partial Edentulism

Keywords

toothlessness

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Bio-Oss®

ACTIVE COMPARATOR

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®

Salvin-Oss®

ACTIVE COMPARATOR

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®

Interventions

Bio-Oss® DEVICE

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

Bio-Oss®

Salvin-Oss® DEVICE

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

Salvin-Oss®

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

Location

Results Point of Contact

• Title: Kerri Font, DDS, MS
• Organization: University of Colorado Denver | Anschutz

clinicalresearchsupportcenter@ucdenver.edu

303-724-1111

Study Officials

• Kerri Font, DDS, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Charles A Powell, DDS, MS

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes. The outcome assessor for histological samples will not be aware of which group the participant was in until code unlocked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly assigned (1:1) to one of two treatment groups (Bio-Oss® or Salvin-Oss®) at the time of surgery through random selection of sealed envelopes.

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 7, 2018
• Study Start: May 22, 2019
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: December 15, 2021
• Results First Posted: December 15, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)