Partial EdentulismNCT03769376
Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
A study testing Bio-Oss® and Salvin-Oss® in people with Partial Edentulism, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Partial Edentulism
- What is being tested?
- Bio-Oss® and Salvin-Oss®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 22 May 2019to 15 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado School of Dental Medicine
Aurora, Colorado, 80045
About this study
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®.
Read the 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.
- Conditions
- Partial Edentulism
- Being tested
- Bio-Oss®, Salvin-Oss®
- Keywords
- toothlessness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss® | Active comparator | 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). Receives: Device: Bio-Oss® |
| Salvin-Oss® | Active comparator | 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). Receives: Device: Salvin-Oss® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 16-20 weeks
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
Measured: Baseline to 16-20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start22 May 2019
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Partial EdentulismStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kerri Font, DDS, MS, Principal investigator, University of Colorado, DenverCharles A Powell, DDS, MS, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769376
- Sponsor's protocol ID
- 18-1722
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2018
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histologic Comparison of Healing After Tooth Extraction With Ridge Preservation Using Two Different Xenografts
- ClinicalTrials.gov ID
- NCT03769376
- Acronym / sponsor ID
- 18-1722
- Conditions
- Partial Edentulism
- Keywords
- toothlessness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 22 May 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss® | Active comparator | Device: 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). |
| Salvin-Oss® | Active comparator | Device: 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). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (6 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-Oss®Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction. | Device | Bio-Oss® |
| Salvin-Oss®Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction. | Device | Salvin-Oss® |
Primary outcome
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.
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerri Font, DDS, MS principal investigator
University of Colorado, Denver
Charles A Powell, DDS, MS principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bio-Oss® and Salvin-Oss® in people with Partial Edentulism, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New Bone Formation at Extraction/Xenograft Site Measured by Histological Evaluation at 16-20 Weeks (time frame: Baseline to 16-20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2021.