Tooth ExtractionNCT03191448
Ridge Preservation Using FDBA and a Collagen Wound Dressing in Molar Sites
A study testing Ridge preservation, FDBA and Collagen wound dressing in people with Tooth Extraction, run by The University of Texas Health Science Center at San Antonio.
Trial summary
Currently, it is not known what the dimensional changes might be following a molar site extraction which has been grafted with FDBA and covered with a collagen wound dressing. The purpose of the proposed study is to examine the clinical healing following ridge preservation using freeze dried bone allograft (FDBA) with… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Ridge preservation, FDBA and Collagen wound dressing
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2015to 6 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- One molar tooth that has been identified by dental faculty as requiring a single tooth extraction
- A dental implant is indicated and treatment planned to replace the missing molar tooth
- Have adequate restorative space for a dental implant-retained restoration
- Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Who cannot join
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
- Clinical and/or radiographic determinations which will preclude inclusion in this study are:
- Active localized or systemic infection other than periodontitis.
- Untreated periodontal diseases
Show all 9Show fewer
- Inadequate bone dimensions or restorative space dimensions to place a dental implant
- Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases.
- Positive medical history of endocarditis following oral or dental surgery.
About this study
Official title: Evaluation of Healing at Molar Extraction Sites With Ridge Preservation Using Freeze Dried Bone Allograft and a Collagen Wound Dressing
Currently, it is not known what the dimensional changes might be following a molar site extraction which has been grafted with FDBA and covered with a collagen wound dressing. The purpose of the proposed study is to examine the clinical healing following ridge preservation using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®) in a molar extraction site.
I
Read the detailed description
It is well known that a tooth socket will undergo significant resorption and remodeling following tooth extraction. Pietrokovsky and Massler documented alveolar bone dimension changes subsequent to tooth extraction forty-five years ago. Schropp et al. evaluated tissue changes on models following premolar and molar extractions and concluded that 50% of the ridge width was lost within one year following extraction. Two thirds of this resorption happened during the first 3 months.
In addition to alveolar ridge resorption in a horizontal dimension (decrease in width), changes in the vertical dimension of the ridge have been documented following tooth extraction in a canine model. The healing pattern of the extraction socket observed in the preclinical setting was further confirmed in human investigations). A systematic review concluded that greater loss of ridge width is to be expected following extraction compared to loss of ridge height. Clinical mean reductions of 3.87mm and 1.87mm in ridge width and height, respectively, were reported. Radiographically, the mean reduction amounted 1.21mm and 1.53mm for ridge width and height, respectively. These results were confirmed by another systematic review.
If the extracted tooth is to be replaced, the unfavorable dimensional changes resulting from this healing process may necessitate advanced and technique sensitive guided bone regeneration (GBR) procedures prior to dental implant placement. In order to avoid GBR and limit these dimensional changes, grafting of the extraction socket with or without membrane coverage, also called ridge preservation procedure, have been advocated. In order to perform ridge preservation, typically, a graft material and some sort of a barrier (e.g. non-resorbable and resorbable membranes or collagen wound dressing) are used. A large variety of materials are available on the market for the purpose of ridge preservation. No material gold standard has yet been identified to date, which would ensure the best dimensional stability of the alveolar ridge.
Current materials used as part of standard care in clinical practice include freeze dried bone allograft (FDBA) as a grafting material and a dense polytetrafluroethylene (dPTFE) non-resorbable membrane or a collagen wound dressing (Collaplug®, Zimmer Dental, Carlsbad, CA) to protect the extraction grafted site. It is currently now known how the use of a collagen wound dressing would compare to a non-resorbable membrane (which has been documented) and if any would lead to any substantial clinical advantages.
Therefore, the proposed research project will answer the following question:
What are the dimensional changes of the hard and soft tissues encountered following molar extractions with ridge preservation using FDBA and a collagen wound dressing?
- Conditions
- Tooth Extraction
- Being tested
- Ridge preservation, FDBA, Collagen wound dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ridge preservationProcedure or surgery
Also called Socket preservation, Socket grafting
Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously.
FDBADevice
Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)
Collagen wound dressingDevice
Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)
| Study group | Role | What they receive |
|---|---|---|
| Ridge preservation in molar sites | Experimental | Patient who will need a single molar site extracted as part of their treatment will be screened and consented for this research study.
Ridge preservation will be performed in single molar extraction site. The site will be grafted with freezed dried bone allograft (FDBA) and covered with a collagen wound dressing (Collaplug). This is already part of clinical standard care using FDA approved products in an FDA approved fashion. The study aims at documenting the clinical outcome of such accepted procedure more precisely and compare it existing data using other materials. Receives: Procedure: Ridge preservation; Device: FDBA; Device: Collagen wound dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic bone width changes (in mm)
Following extraction and ridge preservation the alveolar bone around the extraction socket will remodel and some resorption is expected. Alveolar ridge width change (in mm) at the extraction site will be recorded by means of Cone Beam Computed Tomography (CBCT)
Measured: 3 months
Secondary outcomes (1)
Radiographic bone height changes (in mm)
Following extraction and ridge preservation the alveolar bone around the extraction socket will remodel and some resorption is expected. Alveolar ridge height change (in mm) at the extraction site will be recorded by means of Cone Beam Computed Tomography (CBCT)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2017
- Study start11 Nov 2015
- Primary completion6 Apr 2018
- Study completion6 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Tooth ExtractionStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study will document the use of standard care treatment using FDA approved material used in an FDA approved fashion.
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guy Huynh-Ba, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03191448
- Sponsor's protocol ID
- HSC20150708H
- Status last verified
- Apr 2018
- First submitted
- 15 Jun 2017
- Last updated
- 9 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
PubMed 15691354Araujo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x.
PubMed 19522974Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
PubMed 18672985Braut V, Bornstein MM, Lauber R, Buser D. Bone dimensions in the posterior mandible: a retrospective radiographic study using cone beam computed tomography. Part 1--analysis of dentate sites. Int J Periodontics Restorative Dent. 2012 Apr;32(2):175-84.
PubMed 22292147Brownfield LA, Weltman RL. Ridge preservation with or without an osteoinductive allograft: a clinical, radiographic, micro-computed tomography, and histologic study evaluating dimensional changes and new bone formation of the alveolar ridge. J Periodontol. 2012 May;83(5):581-9. doi: 10.1902/jop.2011.110365. Epub 2011 Sep 26.
PubMed 21942791Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
PubMed 19885449Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. doi: 10.1111/j.1600-0501.2009.01825.x. Epub 2009 Nov 13.
PubMed 19912273Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42. doi: 10.1111/j.1600-0501.2009.01870.x.
PubMed 20070745Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
PubMed 12931761Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
PubMed 16515093Oghli AA, Steveling H. Ridge preservation following tooth extraction: a comparison between atraumatic extraction and socket seal surgery. Quintessence Int. 2010 Jul-Aug;41(7):605-9.
PubMed 20614049Spray JR, Black CG, Morris HF, Ochi S. The influence of bone thickness on facial marginal bone response: stage 1 placement through stage 2 uncovering. Ann Periodontol. 2000 Dec;5(1):119-28. doi: 10.1902/annals.2000.5.1.119.
PubMed 11885170Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x.
PubMed 22211303Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x.
PubMed 19929956Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x.
PubMed 22211304
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Healing at Molar Extraction Sites With Ridge Preservation Using Freeze Dried Bone Allograft and a Collagen Wound Dressing
- ClinicalTrials.gov ID
- NCT03191448
- Acronym / sponsor ID
- HSC20150708H
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 6 Apr 2018 (actual)
- Study completion
- 6 Apr 2018 (actual)
- First posted
- 19 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Currently, it is not known what the dimensional changes might be following a molar site extraction which has been grafted with FDBA and covered with a collagen wound dressing. The purpose of the proposed study is to examine the clinical healing following ridge preservation using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®) in a molar extraction site.
I
Detailed description
It is well known that a tooth socket will undergo significant resorption and remodeling following tooth extraction. Pietrokovsky and Massler documented alveolar bone dimension changes subsequent to tooth extraction forty-five years ago. Schropp et al. evaluated tissue changes on models following premolar and molar extractions and concluded that 50% of the ridge width was lost within one year following extraction. Two thirds of this resorption happened during the first 3 months.
In addition to alveolar ridge resorption in a horizontal dimension (decrease in width), changes in the vertical dimension of the ridge have been documented following tooth extraction in a canine model. The healing pattern of the extraction socket observed in the preclinical setting was further confirmed in human investigations). A systematic review concluded that greater loss of ridge width is to be expected following extraction compared to loss of ridge height. Clinical mean reductions of 3.87mm and 1.87mm in ridge width and height, respectively, were reported. Radiographically, the mean reduction amounted 1.21mm and 1.53mm for ridge width and height, respectively. These results were confirmed by another systematic review.
If the extracted tooth is to be replaced, the unfavorable dimensional changes resulting from this healing process may necessitate advanced and technique sensitive guided bone regeneration (GBR) procedures prior to dental implant placement. In order to avoid GBR and limit these dimensional changes, grafting of the extraction socket with or without membrane coverage, also called ridge preservation procedure, have been advocated. In order to perform ridge preservation, typically, a graft material and some sort of a barrier (e.g. non-resorbable and resorbable membranes or collagen wound dressing) are used. A large variety of materials are available on the market for the purpose of ridge preservation. No material gold standard has yet been identified to date, which would ensure the best dimensional stability of the alveolar ridge.
Current materials used as part of standard care in clinical practice include freeze dried bone allograft (FDBA) as a grafting material and a dense polytetrafluroethylene (dPTFE) non-resorbable membrane or a collagen wound dressing (Collaplug®, Zimmer Dental, Carlsbad, CA) to protect the extraction grafted site. It is currently now known how the use of a collagen wound dressing would compare to a non-resorbable membrane (which has been documented) and if any would lead to any substantial clinical advantages.
Therefore, the proposed research project will answer the following question:
What are the dimensional changes of the hard and soft tissues encountered following molar extractions with ridge preservation using FDBA and a collagen wound dressing?
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will document the use of standard care treatment using FDA approved material used in an FDA approved fashion.
| Arm | Type | Receives |
|---|---|---|
| Ridge preservation in molar sites | Experimental | Procedure: Ridge preservation, Device: FDBA, Device: Collagen wound dressingPatient who will need a single molar site extracted as part of their treatment will be screened and consented for this research study. Ridge preservation will be performed in single molar extraction site. The site will be grafted with freezed dried bone allograft (FDBA) and covered with a collagen wound dressing (Collaplug). This is already part of clinical standard care using FDA approved products in an FDA approved fashion. The study aims at documenting the clinical outcome of such accepted procedure more precisely and compare it existing data using other materials. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- One molar tooth that has been identified by dental faculty as requiring a single tooth extraction
- A dental implant is indicated and treatment planned to replace the missing molar tooth
- Have adequate restorative space for a dental implant-retained restoration
- Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal.
Key exclusion criteria (9 listed)
- Patients will not be entered who are mentally incompetent, prisoners, or pregnant.
- Pregnant women or women intending to become pregnant during the study period.
- Patients who become pregnant during the study will be withdrawn and standard care will be delivered.
- Clinical and/or radiographic determinations which will preclude inclusion in this study are:
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 |
|---|---|---|
| Ridge preservationAlso: Socket preservation, Socket graftingRidge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. | Procedure or surgery | Ridge preservation in molar sites |
| FDBARidge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug) | Device | Ridge preservation in molar sites |
| Collagen wound dressingRidge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug) | Device | Ridge preservation in molar sites |
Primary outcome
Radiographic bone width changes (in mm)
Time frame: 3 months
Following extraction and ridge preservation the alveolar bone around the extraction socket will remodel and some resorption is expected. Alveolar ridge width change (in mm) at the extraction site will be recorded by means of Cone Beam Computed Tomography (CBCT)
1 secondary outcome
Radiographic bone height changes (in mm)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Background: PubMed 15691354Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
- Background: PubMed 19522974Araujo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x.
- Background: PubMed 18672985Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628.
- Background: PubMed 22292147Braut V, Bornstein MM, Lauber R, Buser D. Bone dimensions in the posterior mandible: a retrospective radiographic study using cone beam computed tomography. Part 1--analysis of dentate sites. Int J Periodontics Restorative Dent. 2012 Apr;32(2):175-84.
- Background: PubMed 21942791Brownfield LA, Weltman RL. Ridge preservation with or without an osteoinductive allograft: a clinical, radiographic, micro-computed tomography, and histologic study evaluating dimensional changes and new bone formation of the alveolar ridge. J Periodontol. 2012 May;83(5):581-9. doi: 10.1902/jop.2011.110365. Epub 2011 Sep 26.
- Background: PubMed 19885449Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
- Background: PubMed 19912273Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. doi: 10.1111/j.1600-0501.2009.01825.x. Epub 2009 Nov 13.
- Background: PubMed 20070745Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42. doi: 10.1111/j.1600-0501.2009.01870.x.
- Background: PubMed 12931761Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
- Background: PubMed 16515093Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29.
- Background: PubMed 20614049Oghli AA, Steveling H. Ridge preservation following tooth extraction: a comparison between atraumatic extraction and socket seal surgery. Quintessence Int. 2010 Jul-Aug;41(7):605-9.
- Background: PubMed 11885170Spray JR, Black CG, Morris HF, Ochi S. The influence of bone thickness on facial marginal bone response: stage 1 placement through stage 2 uncovering. Ann Periodontol. 2000 Dec;5(1):119-28. doi: 10.1902/annals.2000.5.1.119.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Ridge preservation, FDBA and Collagen wound dressing in people with Tooth Extraction, run by The University of Texas Health Science Center at San Antonio.
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 4 inclusion and 9 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 9 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiographic bone width changes (in mm) (time frame: 3 months). 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 NCT03191448, which also lists 15 linked publications.
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 9 Apr 2018.