Tooth LossPhase 4OSTEO2NCT02980211
Treatment of Post-Extraction Dehisced Socket - A Case Series Study
A Phase 4 study testing Alveolar Ridge Reconstruction in people with Tooth Loss, run by Gustavo Avila-Ortiz DDS, MS, PhD at 1 site in United States.
Trial summary
PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tooth Loss
- What is being tested?
- Alveolar Ridge Reconstruction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2017to 17 May 2018
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent
- Age: 18 years or older
- Subjects with a single-rooted tooth indicated for extraction bounded by stable, natural teeth
- Tooth planned for extraction must have a dehiscence defect in the surrounding bone, observed clinically and/or radiographically, that affects at least 50% of the bone height
- Subjects must be interested in replacing the tooth with a single implant-supported fixed restoration
- Subjects must be able and willing to follow instructions related to the study procedures
- Subjects must have read, understood and signed an informed consent form
Who cannot join
- Mandibular incisors
- Subjects with a history of organ failure (e.g. liver, kidney)
- Subjects with severe hematologic disorders, such as hemophilia or leukemia
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
- Pregnant women (as indicated by positive serum HCG test) or nursing mothers
- Subjects with conditions that would result in compromised healing (e.g. poorly controlled diabetes, active heavy tobacco use [>10 cigs/day])
- Subjects who, at the discretion of the investigators, would be unsuitable candidates for the study due to safety, psychological or practical reasons (e.g. known allergies to any product used for the study, limited mouth opening, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa College of Dentistry - Craniofacial Clinical Research Program
Iowa City, Iowa, 52242
About this study
Official title: Clinical, Radiographic and Histologic Evaluation of a Novel Alveolar Ridge Reconstruction Approach in Post-Extraction Dehiscence Defects: A Case Series Study
PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.
METHODS Subjects with single-rooted teeth indicated for extraction and interested in future implant therapy for tooth replacement will be recruited on the basis of an eligibility criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon clinical examination in order for the subject to qualify for study inclusion. A cone-beam computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be obtained prior to tooth extraction. Following minimally invasive tooth extraction and debridement, the socket will be evaluated to verify the presence of a dehiscence defect affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be trimmed to a size and shape that would allow for complete extension over the existing defect will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be grafted with particulate allograft and the access to the socket will be sealed with an extension of the membrane and an external cross mattress suture. Subjects will be recalled at 1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and the exposed area will be left to heal by secondary intention. At 20 weeks after tooth extraction a second CBCT will be obtained to radiographically evaluate the site for implant placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks will be made using the CBCT data to assess changes affecting the bone housing. If the site has healed adequately, implant placement will be planned at 24 weeks after tooth extraction. A bone core biopsy will be obtained at the time of implant placement in order to histologically analyze the characteristics of the grafted substrate. Upon implant placement with primary stability a healing abutment will be placed and sutures will be given to achieve primary wound closure, as necessary. Subjects will return for the final study visit at 2 weeks following implant placement to evaluate the healing prior to being referred back to the restorative dentist.
Read the detailed description
Visit 1 - Screening visit After reading and signing this informed consent form, you will complete a detailed medical and dental history form. We will review this form with you to ensure you can safely participate in the study. You will also have an oral exam to determine if you qualify for the study. If you are a woman of childbearing age, you will be tested for pregnancy. If you are pregnant or trying to become pregnant, you cannot participate in the study. You will also have one digital dental x-ray of the area for tooth extraction, if not available already, which is standard of care. You will also have dental impressions (molds of your teeth), which are made in a non-invasive manner to collect data for some of the research measurements. This visit will last between 1 and 1.5 hours.
Visit 2 - Baseline visit In less than 10 weeks after the screening visit, you will have the tooth extraction and bone grafting, which will be just like the procedure performed for patients who are not enrolled in the study and present a similar clinical scenario. Before the surgical procedure, a special dental x-ray scan known as cone beam computed tomography (CBCT) will be taken for the purpose of collecting research measurements. The CBCT scan generates 3D images of your teeth and surrounding tissues. After numbing the area, clinical measurements will be gathered. These measurements are non-invasive (do not involve cutting your body or putting instruments inside it) and will not harm the gums or surrounding teeth. The extraction (removal of the tooth) will be performed and the tooth socket (the area surrounding the tooth that was removed) will be cleaned, which is what would happen to patients who are not enrolled in the study. At this time, additional measurements of the area will be taken. These measurements will not cause you any extra discomfort, since that area will be numbed. Then, the socket grafting technique will be performed. The treatment will consist on the combination of a bone grafting material from a human donor (EnCore, Osteogenics Biomedical Inc.) and a non-dissolvable barrier membrane (Cytoplast TXT-200, Osteogenics Biomedical Inc.), to protect the bone graft and that will be removed in 5 weeks. You will be given prescriptions for an antibiotic, a pain reliever and a mouth rinse. You will also receive home care instructions before you leave. This visit will last about between 1.5 to 2 hours.
Visits 3, 4, 5 and 6 - Post-operative follow up visits You will return to the clinic at 1, 2, 5 and 20 weeks, which is standard of care in many cases of tooth extraction and grafting. In these visits, you will have an oral exam, check-up, and the researchers will monitor how well you are healing. These visits will last approximately 30 minutes.
At the 5-week visit, the barrier membrane will be removed. You will not have to be numbed for this.
Additionally, only at the 20-week visit after tooth extraction, a second CBCT x-ray scan will be obtained to determine how much bone is available after the healing period to plan the implant placement and for research measurements. The second CBCT x-ray scan will allow your surgical doctor to evaluate the amount of bone volume and is standard of care when planning for dental implant placement. A dental impression (mold) will be made to collect information about the gum tissue. Recommendations on further treatment, including the potential for implant therapy or possible additional grafting, will be provided based on the findings from this visit.
Visit 7 - Implant placement visit If you can receive the implant, a surgical placement visit will be scheduled at approximately 24 weeks after tooth extraction. After numbing the area, a small gum flap will be opened to access the area underneath that was bone grafted. A bone sample biopsy will be taken and analyzed for research purposes. This bone would be disposed otherwise, since a bed must be created in the bone to allow for implant placement. After an adequate space for implant placement is created in your bone, the implant will be placed. If implant primary stability (sufficient retention) is not achieved, the doctor may need to place a larger implant (in length, diameter or both) or, if this is not possible, discontinue the procedure and plan for delayed implant placement at another time. If this is the case, the study will cover the costs associated with additional grafting and implant placement. Upon implant placement, your gums will be stitched and you will be given prescriptions for an antibiotic, a pain reliever and a mouth rinse. You will also receive home care instructions before you leave. This visit will last between 1.5 and 2 hours.
Visit 8 - Post-operative follow up visit You will be seen by your surgical doctor for a postoperative visit at approximately 2 weeks after the implant is placed to monitor the healing and to remove sutures, which is standard of care. You will have an oral exam, check-up, and the researchers will monitor how well you are healing. These visits will last approximately 30 minutes. This is the last visit of the study.
- Conditions
- Tooth Loss
- Being tested
- Alveolar Ridge Reconstruction
- Keywords
- Alveolar Bone, Alveolar Ridge, Bone Resorption, Bone Grafting, Barrier Membrane
- Medical subject headings
- Tooth Loss, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar Ridge ReconstructionDrug
Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
| Study group | Role | What they receive |
|---|---|---|
| Tooth Extraction and Graft Dehisced Socket | Experimental | Treatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. Receives: Drug: Alveolar Ridge Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction
Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans
Measured: Baseline and 20 weeks post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start1 Mar 2017
- Primary completion3 May 2018
- Study completion17 May 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.
- Other trials for Tooth LossStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustavo Avila-Ortiz DDS, MS, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Osteogenics Biomedical
- Responsible party
- Sponsor-investigator, Gustavo Avila-Ortiz DDS, MS, PhD, University of Iowa
- Investigators
- Gustavo Avila-Ortiz, DDS, MS, PhD, Principal investigator, College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02980211
- Sponsor's protocol ID
- 201612718
- Acronym
- OSTEO2
- Status last verified
- Jan 2020
- First submitted
- 28 Nov 2016
- Last updated
- 5 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Radiographic and Histologic Evaluation of a Novel Alveolar Ridge Reconstruction Approach in Post-Extraction Dehiscence Defects: A Case Series Study
- ClinicalTrials.gov ID
- NCT02980211
- Acronym / sponsor ID
- OSTEO2 / 201612718
- Conditions
- Tooth Loss
- Keywords
- Alveolar Bone, Alveolar Ridge, Bone Resorption, Bone Grafting, Barrier Membrane
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Gustavo Avila-Ortiz DDS, MS, PhDUniversity, hospital or other
- Collaborators
- Osteogenics Biomedical
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 3 May 2018 (actual)
- Study completion
- 17 May 2018 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Posted 22 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE The purpose of this case series is to clinically, radiographically and histologically evaluate the treatment of dehiscence defects in extraction sockets using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane.
METHODS Subjects with single-rooted teeth indicated for extraction and interested in future implant therapy for tooth replacement will be recruited on the basis of an eligibility criteria. A buccal or lingual dehiscence defect must strongly be suspected or confirmed upon clinical examination in order for the subject to qualify for study inclusion. A cone-beam computer tomography (CBCT) scan of the arch containing the tooth to be extracted will be obtained prior to tooth extraction. Following minimally invasive tooth extraction and debridement, the socket will be evaluated to verify the presence of a dehiscence defect affecting at least 50% of the bony plate height. After creating a soft tissue 'pouch' using tunneling instruments, a non-absorbable dense-PTFE (dPTFE) barrier membrane that will be trimmed to a size and shape that would allow for complete extension over the existing defect will be tucked between the mucosa and the alveolar bone. Then, the extraction socket will be grafted with particulate allograft and the access to the socket will be sealed with an extension of the membrane and an external cross mattress suture. Subjects will be recalled at 1, 2 and 5 weeks to monitor healing and assess the level of discomfort using a visual analog scale at the end of each visit. At the 5-week visit, the membrane will be gently removed and the exposed area will be left to heal by secondary intention. At 20 weeks after tooth extraction a second CBCT will be obtained to radiographically evaluate the site for implant placement. Bone volumetric reconstructions of the alveolar ridge at baseline and at 20 weeks will be made using the CBCT data to assess changes affecting the bone housing. If the site has healed adequately, implant placement will be planned at 24 weeks after tooth extraction. A bone core biopsy will be obtained at the time of implant placement in order to histologically analyze the characteristics of the grafted substrate. Upon implant placement with primary stability a healing abutment will be placed and sutures will be given to achieve primary wound closure, as necessary. Subjects will return for the final study visit at 2 weeks following implant placement to evaluate the healing prior to being referred back to the restorative dentist.
Detailed description
Visit 1 - Screening visit After reading and signing this informed consent form, you will complete a detailed medical and dental history form. We will review this form with you to ensure you can safely participate in the study. You will also have an oral exam to determine if you qualify for the study. If you are a woman of childbearing age, you will be tested for pregnancy. If you are pregnant or trying to become pregnant, you cannot participate in the study. You will also have one digital dental x-ray of the area for tooth extraction, if not available already, which is standard of care. You will also have dental impressions (molds of your teeth), which are made in a non-invasive manner to collect data for some of the research measurements. This visit will last between 1 and 1.5 hours.
Visit 2 - Baseline visit In less than 10 weeks after the screening visit, you will have the tooth extraction and bone grafting, which will be just like the procedure performed for patients who are not enrolled in the study and present a similar clinical scenario. Before the surgical procedure, a special dental x-ray scan known as cone beam computed tomography (CBCT) will be taken for the purpose of collecting research measurements. The CBCT scan generates 3D images of your teeth and surrounding tissues. After numbing the area, clinical measurements will be gathered. These measurements are non-invasive (do not involve cutting your body or putting instruments inside it) and will not harm the gums or surrounding teeth. The extraction (removal of the tooth) will be performed and the tooth socket (the area surrounding the tooth that was removed) will be cleaned, which is what would happen to patients who are not enrolled in the study. At this time, additional measurements of the area will be taken. These measurements will not cause you any extra discomfort, since that area will be numbed. Then, the socket grafting technique will be performed. The treatment will consist on the combination of a bone grafting material from a human donor (EnCore, Osteogenics Biomedical Inc.) and a non-dissolvable barrier membrane (Cytoplast TXT-200, Osteogenics Biomedical Inc.), to protect the bone graft and that will be removed in 5 weeks. You will be given prescriptions for an antibiotic, a pain reliever and a mouth rinse. You will also receive home care instructions before you leave. This visit will last about between 1.5 to 2 hours.
Visits 3, 4, 5 and 6 - Post-operative follow up visits You will return to the clinic at 1, 2, 5 and 20 weeks, which is standard of care in many cases of tooth extraction and grafting. In these visits, you will have an oral exam, check-up, and the researchers will monitor how well you are healing. These visits will last approximately 30 minutes.
At the 5-week visit, the barrier membrane will be removed. You will not have to be numbed for this.
Additionally, only at the 20-week visit after tooth extraction, a second CBCT x-ray scan will be obtained to determine how much bone is available after the healing period to plan the implant placement and for research measurements. The second CBCT x-ray scan will allow your surgical doctor to evaluate the amount of bone volume and is standard of care when planning for dental implant placement. A dental impression (mold) will be made to collect information about the gum tissue. Recommendations on further treatment, including the potential for implant therapy or possible additional grafting, will be provided based on the findings from this visit.
Visit 7 - Implant placement visit If you can receive the implant, a surgical placement visit will be scheduled at approximately 24 weeks after tooth extraction. After numbing the area, a small gum flap will be opened to access the area underneath that was bone grafted. A bone sample biopsy will be taken and analyzed for research purposes. This bone would be disposed otherwise, since a bed must be created in the bone to allow for implant placement. After an adequate space for implant placement is created in your bone, the implant will be placed. If implant primary stability (sufficient retention) is not achieved, the doctor may need to place a larger implant (in length, diameter or both) or, if this is not possible, discontinue the procedure and plan for delayed implant placement at another time. If this is the case, the study will cover the costs associated with additional grafting and implant placement. Upon implant placement, your gums will be stitched and you will be given prescriptions for an antibiotic, a pain reliever and a mouth rinse. You will also receive home care instructions before you leave. This visit will last between 1.5 and 2 hours.
Visit 8 - Post-operative follow up visit You will be seen by your surgical doctor for a postoperative visit at approximately 2 weeks after the implant is placed to monitor the healing and to remove sutures, which is standard of care. You will have an oral exam, check-up, and the researchers will monitor how well you are healing. These visits will last approximately 30 minutes. This is the last visit of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tooth Extraction and Graft Dehisced Socket | Experimental | Drug: Alveolar Ridge ReconstructionTreatment of dehiscence defects at the time of tooth extraction using a minimally-invasive GBR technique that involves the application of a particulate bone allograft and a non-resorbable PTFE membrane. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provision of informed consent
- Age: 18 years or older
- Subjects with a single-rooted tooth indicated for extraction bounded by stable, natural teeth
- Tooth planned for extraction must have a dehiscence defect in the surrounding bone, observed clinically and/or radiographically, that affects at least 50% of the bone height
- Subjects must be interested in replacing the tooth with a single implant-supported fixed restoration
Key exclusion criteria (8 listed)
- Mandibular incisors
- Subjects with a history of organ failure (e.g. liver, kidney)
- Subjects with severe hematologic disorders, such as hemophilia or leukemia
- Subjects with uncontrolled and/or severe metabolic bone diseases or disorders, such as osteoporosis, thyroid disorders or Paget's disease
- Subjects taking any medication or supplement known to largely influence bone metabolism, such as IV bisphosphonates, long-term history of oral bisphosphonates or chronic intake of glucocorticoids
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 |
|---|---|---|
| Alveolar Ridge ReconstructionReconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane | Drug | Tooth Extraction and Graft Dehisced Socket |
Primary outcome
Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction
Time frame: Baseline and 20 weeks post-extraction
Alveolar bone volumetric reduction from baseline to 20 weeks using CBCT scans
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- 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.
Gustavo Avila-Ortiz, DDS, MS, PhD principal investigator
College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Alveolar Ridge Reconstruction in people with Tooth Loss, run by Gustavo Avila-Ortiz DDS, MS, PhD 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 7 inclusion and 8 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 5 Feb 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2020). 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?
Bone Volumetric Reduction From Baseline to 20 Weeks Post-extraction (time frame: Baseline and 20 weeks post-extraction). 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 5 Feb 2020.