Alveolar Bone LossNCT02802319
Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials
A study testing Porcine Xenograft (Zcore) and Bovine Xenograft (Bio-Oss) in people with Alveolar Bone Loss, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This protocol involves procedures that are standard care. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- Porcine Xenograft (Zcore) and Bovine Xenograft (Bio-Oss)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Sep 2018
- 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 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients will be included in this study if they qualify the following inclusion criteria:
- Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol
- A single rooted tooth that has been identified as requiring extraction
- Desire a dental implant to replace the missing tooth
- Have adequate restorative space for a dental implant-retained restoration
Show all 10Show fewer
- Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
- Have a dehiscence of the buccal or lingual bony plate of the tooth socket extending no more than 50% of the total depth of the socket.
- Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non-pregnant women of child-bearing potential.
- Are nonsmokers or former smokers. Current smokers may only be included if they smoke <10 cigarettes per day
Who cannot join
- Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
- Patients will are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Smokers who smoke >10 cigarettes per day
- Clinical and/or radiographic determinations which will preclude inclusion in this study are: Active infection other than periodontitis; Inadequate bone dimensions or restorative space for a dental implant; Presence of a disease entity, condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, autoimmune diseases, history of bisphosphonate use or long-term steroid therapy
- Positive medical history of endocarditis following oral or dental surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
UT Health Science Center School of Dentistry
San Antonio, Texas, 78229
About this study
The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Read the detailed description
The study is designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.
This entire protocol involves procedures that are standard care. The study is a 2-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
In keeping with the protocol our study group has used several times before, the plan will be to extract non-molar teeth and graft with the test/control materials. Each subject will provide a single non-molar tooth site for study treatment. The graft material will be covered with a non-resorbable dense polytetrafluoroethylene (d-PTFE) membrane (TXT-200 singles, Osteogenics Inc). This d-PTFE membrane will be removed 4 weeks after placement during the 4-week post-op visit. Following 18-20 weeks of healing, the dental implant will be placed. To place a dental implant, an osteotomy (hole in the bone) is prepared into which the implant is placed. This osteotomy can be prepared with either a solid drill, in which case the bone that is removed is suctioned into the suction system, or with a hollow trephine drill into which a core of bone can be collected. The only "research procedure" being done in the current study is the collection of this bone core biopsy for histologic evaluation. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
- Conditions
- Alveolar Bone Loss
- Being tested
- Porcine Xenograft (Zcore), Bovine Xenograft (Bio-Oss)
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Porcine Xenograft (Zcore)Device
Ridge preservation bone grafting after tooth extraction
Bovine Xenograft (Bio-Oss)Device
Ridge preservation bone grafting after tooth extraction
| Study group | Role | What they receive |
|---|---|---|
| Test: Porcine Xenograft (Zcore) | Experimental | Ridge preservation bone grafting surgery with porcine xenograft (Zcore) Receives: Device: Porcine Xenograft (Zcore) |
| Active Control: Bovine Xenograft (Bio-Oss) | Active comparator | Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss) Receives: Device: Bovine Xenograft (Bio-Oss) |
What is being measured
The primary outcome is the main question the study is designed to answer.
% Vital Bone Formation (Histological)
histologic determination of % vital bone formation
Measured: 18-20 weeks after ridge preservation
Secondary outcomes (1)
% Residual Graft Material (Histological)
histologic determination of % residual bone graft material
Measured: 18-20 weeks after ridge preservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionSep 2018
- Study completionSep 2018
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe 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
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian L Mealey, The University of Texas Health Science Center at San Antonio
- Investigators
- Brian L Mealey, DDS, MS, Principal investigator, UT Health Science Center at San Antonio, School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802319
- Sponsor's protocol ID
- HSC2016-0285H
- Status last verified
- Dec 2018
- First submitted
- 13 Jun 2016
- Last updated
- 8 Jan 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Lai VJ, Michalek JE, Liu Q, Mealey BL. Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial. J Periodontol. 2020 Mar;91(3):361-368. doi: 10.1002/JPER.19-0211. Epub 2019 Aug 23.
PubMed 31380563
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ridge Preservation Following Tooth Extraction Using Porcine and Bovine Xenograft Materials
- ClinicalTrials.gov ID
- NCT02802319
- Acronym / sponsor ID
- HSC2016-0285H
- Conditions
- Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study is a two-arm, parallel-design, randomized, prospective clinical trial designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.This protocol involves procedures that are standard care. All materials are FDA-approved materials being used in an FDA-approved manner. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
Each subjects will have a non-molar tooth extracted and the socket grafted with either test or control graft material. At the time of dental implant placement 18-20 weeks after tooth extraction a small core biopsy specimen will be removed from the implant site. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Detailed description
The study is designed to examine histologic wound healing following ridge preservation using bovine xenograft and porcine xenograft materials.
This entire protocol involves procedures that are standard care. The study is a 2-arm, parallel-design, randomized, prospective clinical trial. The test group subjects will have extraction sockets grafted with porcine xenograft (Zcore). This test group will be compared to an active control group using bovine xenograft (Bio-Oss). The null hypothesis is that there will be no significant difference in formation of new vital bone between treatment groups (primary outcome).
In keeping with the protocol our study group has used several times before, the plan will be to extract non-molar teeth and graft with the test/control materials. Each subject will provide a single non-molar tooth site for study treatment. The graft material will be covered with a non-resorbable dense polytetrafluoroethylene (d-PTFE) membrane (TXT-200 singles, Osteogenics Inc). This d-PTFE membrane will be removed 4 weeks after placement during the 4-week post-op visit. Following 18-20 weeks of healing, the dental implant will be placed. To place a dental implant, an osteotomy (hole in the bone) is prepared into which the implant is placed. This osteotomy can be prepared with either a solid drill, in which case the bone that is removed is suctioned into the suction system, or with a hollow trephine drill into which a core of bone can be collected. The only "research procedure" being done in the current study is the collection of this bone core biopsy for histologic evaluation. The core biopsy will then be evaluated for the primary histologic outcome of % vital bone formation and secondary histologic outcome of % residual graft material.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test: Porcine Xenograft (Zcore) | Experimental | Device: Porcine Xenograft (Zcore)Ridge preservation bone grafting surgery with porcine xenograft (Zcore) |
| Active Control: Bovine Xenograft (Bio-Oss) | Active comparator | Device: Bovine Xenograft (Bio-Oss)Ridge preservation bone grafting surgery with bovine xenograft (Bio-Oss) |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients will be included in this study if they qualify the following inclusion criteria:
- Live within 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Are able to attend a minimum of 6 visits over a 4-5 month period, as required by the study protocol
- A single rooted tooth that has been identified as requiring extraction
- Desire a dental implant to replace the missing tooth
Key exclusion criteria (7 listed)
- Patients who live more than 50 miles from the School of Dentistry, University of Texas Health Science Center at San Antonio
- Patients who do not meet all the inclusion criteria or who will not cooperate with the required follow-up schedule.
- Patients will are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Smokers who smoke >10 cigarettes per day
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 |
|---|---|---|
| Porcine Xenograft (Zcore)Ridge preservation bone grafting after tooth extraction | Device | Test: Porcine Xenograft (Zcore) |
| Bovine Xenograft (Bio-Oss)Ridge preservation bone grafting after tooth extraction | Device | Active Control: Bovine Xenograft (Bio-Oss) |
Primary outcome
% Vital Bone Formation (Histological)
Time frame: 18-20 weeks after ridge preservation
histologic determination of % vital bone formation
1 secondary outcome
% Residual Graft Material (Histological)
Time frame: 18-20 weeks after ridge preservation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31380563Lai VJ, Michalek JE, Liu Q, Mealey BL. Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial. J Periodontol. 2020 Mar;91(3):361-368. doi: 10.1002/JPER.19-0211. Epub 2019 Aug 23.
- Individual participant dataSharing planned: No
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Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
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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.
Brian L Mealey, DDS, MS principal investigator
UT Health Science Center at San Antonio, School of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Porcine Xenograft (Zcore) and Bovine Xenograft (Bio-Oss) in people with Alveolar Bone Loss, run by The University of Texas Health Science Center at San Antonio 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 10 inclusion and 7 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 8 Jan 2019. 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 8 Jan 2019). 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?
% Vital Bone Formation (Histological) (time frame: 18-20 weeks after ridge preservation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02802319, which also lists 1 linked publication.
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 8 Jan 2019.