Partial Edentulism
Conditions
Keywords
toothlessness
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®.
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.
Interventions
DEVICEBio-Oss®
Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.
DEVICESalvin-Oss®
Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | 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. |
| New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
Bio-Oss®: Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. | 20 |
| 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).
Salvin-Oss®: Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. | 18 |
| Total | 38 |
Baseline characteristics
| Characteristic | Bio-Oss® | Salvin-Oss® | Total |
|---|---|---|---|
| Age, Customized <18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Between 18 and 100 years | 20 Participants | 18 Participants | 38 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 20 participants | 18 participants | 38 participants |
| Sex: Female, Male Female | — | — | 0 Participants |
| Sex: Female, Male Male | — | — | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 18 |
| other Total, other adverse events | 0 / 20 | 0 / 18 |
| serious Total, serious adverse events | 0 / 20 | 0 / 18 |
Outcome results
Primary
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.
Time frame: Baseline to 16-20 weeks
Population: Only participants that completed the study are included in the analysis.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Bio-Oss® | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | Vital bone | 29.38 Percent |
| Bio-Oss® | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | Residual graft | 14.02 Percent |
| Bio-Oss® | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | Connective Tissue/other | 56.61 Percent |
| Salvin-Oss® | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | Vital bone | 32.05 Percent |
| Salvin-Oss® | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | Residual graft | 16.56 Percent |
| Salvin-Oss® | New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks | Connective Tissue/other | 51.39 Percent |
Primary
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
Time frame: Baseline to 16-20 weeks
Population: Only participants that completed the study are included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Bio-Oss® | New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks | 15.38 Percent |
| Salvin-Oss® | New Bone Formation at Extraction/Xenograft Site Measured Clinically With Dental Probe at 16-20 Weeks | 9.09 Percent |