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

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ClinicalTrials.gov Identifier: NCT03769376
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

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.




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.



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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.

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


Contacts
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Contact: Kerri Font, DDS, MS 303-724-0695 kerri.font@ucdenver.edu
Contact: Charles A Powell, DDS, MS 303-724-6424 charles.a.powell@ucdenver.edu

Locations
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United States, Colorado
University of Colorado School of Dental Medicine Not yet recruiting
Aurora, Colorado, United States, 80045
Contact: Kerri Font, DDS, MS         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
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Principal Investigator: Kerri Font, DDS, MS University of Colorado, Denver
Principal Investigator: Charles A Powell, DDS, MS University of Colorado, Denver

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03769376     History of Changes
Other Study ID Numbers: 18-1722
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Colorado, Denver:
toothlessness

Additional relevant MeSH terms:
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Salvin
Anti-Infective Agents, Local
Anti-Infective Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs