Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03769376
Recruitment Status : Completed
First Posted : December 7, 2018
Results First Posted : December 15, 2021
Last Update Posted : December 15, 2021
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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®.

Condition or disease Intervention/treatment Phase
Partial Edentulism Device: Bio-Oss® Device: Salvin-Oss® Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Single (Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
Actual Study Start Date : May 22, 2019
Actual Primary Completion Date : March 15, 2021
Actual Study Completion Date : March 15, 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks [ Time Frame: Baseline to 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.

  2. New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks [ Time Frame: Baseline to 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769376


Locations
Layout table for location information
United States, Colorado
University of Colorado School of Dental Medicine
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Layout table for investigator information
Principal Investigator: Kerri Font, DDS, MS University of Colorado, Denver
Principal Investigator: Charles A Powell, DDS, MS University of Colorado, Denver
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Study Protocol and Statistical Analysis Plan  [PDF] September 15, 2021

More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03769376    
Other Study ID Numbers: 18-1722
First Posted: December 7, 2018    Key Record Dates
Results First Posted: December 15, 2021
Last Update Posted: December 15, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by University of Colorado, Denver:
toothlessness
Additional relevant MeSH terms:
Layout table for MeSH terms
Salvin
Anti-Infective Agents, Local
Anti-Infective Agents
Antioxidants
 Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs