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Completed

NCT Number: NCT03769376

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®.

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Key information

Conditions

Partial Edentulism

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado School of Dental Medicine

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bio-Oss®

Device

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

Salvin-Oss®

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 7, 2018
Registry last updated
Dec 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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