N/A
N=38
Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
Partial Edentulism
Bottom Line
View on ClinicalTrials.gov: NCT03769376 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks — 29.38; 32.05; 14.02; 16.56 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bio-Oss® (Device); Salvin-Oss® (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Colorado, Denver
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks |
29.38; 32.05; 14.02; 16.56; 56.61; 51.39 | — |
| PRIMARY New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks |
15.38; 9.09 | — |
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®.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03769376). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.