Edentulous Alveolar RidgeNCT05219305
Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts
A study testing Dental Implant Placement in people with Edentulous Alveolar Ridge, run by University of Oklahoma at 1 site in United States.
Trial summary
The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Alveolar Ridge
- What is being tested?
- Dental Implant Placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2022to Dec 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients ≥18 years old. Current literature suggests that patients up to age 80 can safely receive dental implants. Patients older than 80 can get implant therapy with a rate of implant failure increase of 2.26%, but not statistically significant (Bertl et al. 2019)
- Well-controlled systemic disease.
- Able to understand and sign a written informed consent form and willing to fulfill all study requirements.
Who cannot join
- Uncontrolled systemic disease.
- Currently smoking >10 cigarettes per day.
- History of head and/or neck radiotherapy in the past five years.
- Current use of bisphosphonates or history of IV bisphosphonate therapy.
- Pregnant, expecting to become pregnant, or lactating women.
- Presence of active periodontal disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma College of Dentistry Graduate Periodontics
Oklahoma City, Oklahoma, 73117
About this study
Official title: Autogenous Mineralized Dentin Graft Compared to Partial Demineralized Tooth Graft and to Freeze-Dried Bone Allograft in Dental Implant Placement
The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site.
Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA
Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.
Read the detailed description
This study will be a randomized controlled trial that will assess the changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes recorded by ISQ (Implant Stability Quotient), probing pocket depths, x-ray, and direct clinical measurements which are routinely taken as a standard of care for the dental procedures of implant placement and evaluation. A non-invasive standardizing stent with a caliper will be used for direct measurements and for bitewing radiographs for the purpose of evaluating changes in bone level. Those measurements will be taken immediately at the time of implant placement, and 4-6 months after implant placement. Calibrated examiners will evaluate implant integration. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
Interventions and follow-up appointments will be conducted at the University of Oklahoma (OU), Graduate Periodontics clinic. Approximately 5 visits are anticipated for each patient. Additional appointments may be needed depending on surgical complications that need attention or intervention. Following the completion of the study, the participants will be placed on appropriate recall schedules either at the Graduate Periodontics clinic or referred to their dentist of choice. The subject's information will not be used or distributed for future research studies even if identifiers are removed.
Patients from the previous study "Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". A total of 60 patients treated with Alveolar Ridge Preservation will be eligible for implant placement.
Protocol of the experiment is as follows:
- Surgical intervention for implant placement (for all the groups).
- 2-week follow-up after implant placement.
- 6-week follow-up after implant placement.
- 4-6 month follow-up after implant placement.
- Restoration of the implant by the restorative dentist.
- Data analysis
During the implant placement phase, at 4 to 6 months postoperative from the grafted sites, bone core sample will be collected using a trephine bur. Collection of sample with a trephine bur will come from area of bone being prepared for the dental implant and will be of a size that would have been removed during dental implant preparation anyway. This will occur during the same appointment as dental implant placement. The collected specimens will be labeled (name of the patient, date, and chart number) and sent to the OU Department of Oral Pathology where it will be analyzed for newly formed bone and the amount of residual bone graft material. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
No population will be excluded based on race or gender. Patients under 18 years old will be excluded due to the ongoing growth potential of the alveolar bone at a younger age.
This study will be conducted at the University of Oklahoma, College of Dentistry, Department of Graduate Periodontics. Participants will be selected from patients of the College of Dentistry. Qualifying subjects will be scheduled for a screening examination appointment.
- Conditions
- Edentulous Alveolar Ridge
- Being tested
- Dental Implant Placement
- Keywords
- dental implant,, autogenous dentin graft, autograft, allograft, bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Implant PlacementDevice
Placement in an edentulous site that was previously bone grafted in the prior study.
| Study group | Role | What they receive |
|---|---|---|
| Freeze-Dried Bone Allograft | Experimental | edentulous site grafted with FDBA in previous study. Receives: Device: Dental Implant Placement |
| Partially-demineralized tooth graft | Experimental | edentulous site grafted with partially-demineralized tooth graft in the previous study. Receives: Device: Dental Implant Placement |
| mineralized tooth graft | Experimental | edentulous site grafted with mineralized tooth graft in the previous study. Receives: Device: Dental Implant Placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Stability as Measured with ISQ values of implant
Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments
Measured: 6 months
Implant Failure Rate
Necessity of implant of implant removal from oral cavity
Measured: 6 months
Probing pocket depth
measuring the depth of the periodontal pocket alongside the dental implant
Measured: 6 months
Interproximal crestal bone level
radiographically assess bone level changes adjacent to dental implant
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start1 Apr 2022
- Primary completion10 Aug 2023
- Study completionDec 2024 (estimated)
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 Edentulous Alveolar RidgeStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- All participants originate from previous study ""Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". They have already been assigned and treated with different types of bone grafts. They were assigned groups via a computer randomization program.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- Robin Henderson, DDS, MS, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05219305
- Sponsor's protocol ID
- 14063
- Status last verified
- Aug 2024
- First submitted
- 18 Jan 2022
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study records will be stored in a locked room and electronic records will be stored on an encrypted server, which meets the University IT Security requirements. Patient information will be kept within the University of Oklahoma. These records will be stored indefinitely on the server and available to copying and for future studies if requested under the supervision of a designated representative and in accordance with federal regulations.
Publications
Jung RE, Fenner N, Hammerle CH, Zitzmann NU. Long-term outcome of implants placed with guided bone regeneration (GBR) using resorbable and non-resorbable membranes after 12-14 years. Clin Oral Implants Res. 2013 Oct;24(10):1065-73. doi: 10.1111/j.1600-0501.2012.02522.x. Epub 2012 Jun 15.
PubMed 22697628Murata, M. "Autogenous demineralized dentin matrix for maxillary sinus augmentation in human. The first clinical report." Journal of Dental Reseach., 82, B243.
Ike M, Urist MR. Recycled dentin root matrix for a carrier of recombinant human bone morphogenetic protein. J Oral Implantol. 1998;24(3):124-32. doi: 10.1563/1548-1336(1998)0242.3.CO;2.
PubMed 9893518Saygin NE, Tokiyasu Y, Giannobile WV, Somerman MJ. Growth factors regulate expression of mineral associated genes in cementoblasts. J Periodontol. 2000 Oct;71(10):1591-600. doi: 10.1902/jop.2000.71.10.1591.
PubMed 11063392Emecen P, Akman AC, Hakki SS, Hakki EE, Demiralp B, Tozum TF, Nohutcu RM. ABM/P-15 modulates proliferation and mRNA synthesis of growth factors of periodontal ligament cells. Acta Odontol Scand. 2009;67(2):65-73. doi: 10.1080/00016350802555525.
PubMed 19031159Seo BM, Sonoyama W, Yamaza T, Coppe C, Kikuiri T, Akiyama K, Lee JS, Shi S. SHED repair critical-size calvarial defects in mice. Oral Dis. 2008 Jul;14(5):428-34. doi: 10.1111/j.1601-0825.2007.01396.x.
PubMed 18938268Kim YK, Kim SG, Byeon JH, Lee HJ, Um IU, Lim SC, Kim SY. Development of a novel bone grafting material using autogenous teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):496-503. doi: 10.1016/j.tripleo.2009.10.017. Epub 2010 Jan 8.
PubMed 20060336Kim YK, Kim SG, Yun PY, Yeo IS, Jin SC, Oh JS, Kim HJ, Yu SK, Lee SY, Kim JS, Um IW, Jeong MA, Kim GW. Autogenous teeth used for bone grafting: a comparison with traditional grafting materials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Jan;117(1):e39-45. doi: 10.1016/j.oooo.2012.04.018. Epub 2012 Aug 30.
PubMed 22939321Koga T, Minamizato T, Kawai Y, Miura K, I T, Nakatani Y, Sumita Y, Asahina I. Bone Regeneration Using Dentin Matrix Depends on the Degree of Demineralization and Particle Size. PLoS One. 2016 Jan 21;11(1):e0147235. doi: 10.1371/journal.pone.0147235. eCollection 2016.
PubMed 26795024Binderman, Itzhak, Gideon Hallel, Casap Nardy, Avinoam Yaffe, and Lari Sapoznikov.
Phillips DJ, Swenson DT, Johnson TM. Buccal bone thickness adjacent to virtual dental implants following guided bone regeneration. J Periodontol. 2019 Jun;90(6):595-607. doi: 10.1002/JPER.18-0304. Epub 2019 Jan 10.
PubMed 30578550Bertl K, Ebner M, Knibbe M, Pandis N, Kuchler U, Ulm C, Stavropoulos A. How old is old for implant therapy in terms of early implant losses? J Clin Periodontol. 2019 Dec;46(12):1282-1293. doi: 10.1111/jcpe.13199. Epub 2019 Nov 8.
PubMed 31529723Binderman, I., Hallel, G., Nardy, C., Yaffe, A., & Sapoznikov, L. (2014). A novel procedure to process extracted teeth for immediate grafting of autogenous dentin. J Interdiscipl Med Dent Sci, 2(154), 2.
Korsch M. Tooth shell technique: A proof of concept with the use of autogenous dentin block grafts. Aust Dent J. 2021 Jun;66(2):159-168. doi: 10.1111/adj.12814. Epub 2021 Jan 25.
PubMed 33370452Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.
PubMed 30904559
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autogenous Mineralized Dentin Graft Compared to Partial Demineralized Tooth Graft and to Freeze-Dried Bone Allograft in Dental Implant Placement
- ClinicalTrials.gov ID
- NCT05219305
- Acronym / sponsor ID
- 14063
- Conditions
- Edentulous Alveolar Ridge
- Keywords
- dental implant,, autogenous dentin graft, autograft, allograft, bone graft
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 2 Feb 2022 (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.
The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to their properties of osteogenesis, osteoinduction, and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site.
Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA
Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.
Detailed description
This study will be a randomized controlled trial that will assess the changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes recorded by ISQ (Implant Stability Quotient), probing pocket depths, x-ray, and direct clinical measurements which are routinely taken as a standard of care for the dental procedures of implant placement and evaluation. A non-invasive standardizing stent with a caliper will be used for direct measurements and for bitewing radiographs for the purpose of evaluating changes in bone level. Those measurements will be taken immediately at the time of implant placement, and 4-6 months after implant placement. Calibrated examiners will evaluate implant integration. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
Interventions and follow-up appointments will be conducted at the University of Oklahoma (OU), Graduate Periodontics clinic. Approximately 5 visits are anticipated for each patient. Additional appointments may be needed depending on surgical complications that need attention or intervention. Following the completion of the study, the participants will be placed on appropriate recall schedules either at the Graduate Periodontics clinic or referred to their dentist of choice. The subject's information will not be used or distributed for future research studies even if identifiers are removed.
Patients from the previous study "Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". A total of 60 patients treated with Alveolar Ridge Preservation will be eligible for implant placement.
Protocol of the experiment is as follows:
- Surgical intervention for implant placement (for all the groups).
- 2-week follow-up after implant placement.
- 6-week follow-up after implant placement.
- 4-6 month follow-up after implant placement.
- Restoration of the implant by the restorative dentist.
- Data analysis
During the implant placement phase, at 4 to 6 months postoperative from the grafted sites, bone core sample will be collected using a trephine bur. Collection of sample with a trephine bur will come from area of bone being prepared for the dental implant and will be of a size that would have been removed during dental implant preparation anyway. This will occur during the same appointment as dental implant placement. The collected specimens will be labeled (name of the patient, date, and chart number) and sent to the OU Department of Oral Pathology where it will be analyzed for newly formed bone and the amount of residual bone graft material. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.
No population will be excluded based on race or gender. Patients under 18 years old will be excluded due to the ongoing growth potential of the alveolar bone at a younger age.
This study will be conducted at the University of Oklahoma, College of Dentistry, Department of Graduate Periodontics. Participants will be selected from patients of the College of Dentistry. Qualifying subjects will be scheduled for a screening examination appointment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- All participants originate from previous study ""Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". They have already been assigned and treated with different types of bone grafts. They were assigned groups via a computer randomization program.
| Arm | Type | Receives |
|---|---|---|
| Freeze-Dried Bone Allograft | Experimental | Device: Dental Implant Placementedentulous site grafted with FDBA in previous study. |
| Partially-demineralized tooth graft | Experimental | Device: Dental Implant Placementedentulous site grafted with partially-demineralized tooth graft in the previous study. |
| mineralized tooth graft | Experimental | Device: Dental Implant Placementedentulous site grafted with mineralized tooth graft in the previous study. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients ≥18 years old. Current literature suggests that patients up to age 80 can safely receive dental implants. Patients older than 80 can get implant therapy with a rate of implant failure increase of 2.26%, but not statistically significant (Bertl et al. 2019)
- Well-controlled systemic disease.
- Able to understand and sign a written informed consent form and willing to fulfill all study requirements.
Key exclusion criteria (6 listed)
- Uncontrolled systemic disease.
- Currently smoking >10 cigarettes per day.
- History of head and/or neck radiotherapy in the past five years.
- Current use of bisphosphonates or history of IV bisphosphonate therapy.
- Pregnant, expecting to become pregnant, or lactating women.
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 |
|---|---|---|
| Dental Implant PlacementPlacement in an edentulous site that was previously bone grafted in the prior study. | Device | Freeze-Dried Bone Allograft, Partially-demineralized tooth graft, mineralized tooth graft |
Primary outcome
Implant Stability as Measured with ISQ values of implant
Time frame: 6 months
Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments
Implant Failure Rate
Time frame: 6 months
Necessity of implant of implant removal from oral cavity
Probing pocket depth
Time frame: 6 months
measuring the depth of the periodontal pocket alongside the dental implant
Interproximal crestal bone level
Time frame: 6 months
radiographically assess bone level changes adjacent to dental implant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Results publication: PubMed 22697628Jung RE, Fenner N, Hammerle CH, Zitzmann NU. Long-term outcome of implants placed with guided bone regeneration (GBR) using resorbable and non-resorbable membranes after 12-14 years. Clin Oral Implants Res. 2013 Oct;24(10):1065-73. doi: 10.1111/j.1600-0501.2012.02522.x. Epub 2012 Jun 15.
- Results publicationMurata, M. "Autogenous demineralized dentin matrix for maxillary sinus augmentation in human. The first clinical report." Journal of Dental Reseach., 82, B243.
- Results publication: PubMed 9893518Ike M, Urist MR. Recycled dentin root matrix for a carrier of recombinant human bone morphogenetic protein. J Oral Implantol. 1998;24(3):124-32. doi: 10.1563/1548-1336(1998)0242.3.CO;2.
- Results publication: PubMed 11063392Saygin NE, Tokiyasu Y, Giannobile WV, Somerman MJ. Growth factors regulate expression of mineral associated genes in cementoblasts. J Periodontol. 2000 Oct;71(10):1591-600. doi: 10.1902/jop.2000.71.10.1591.
- Results publication: PubMed 19031159Emecen P, Akman AC, Hakki SS, Hakki EE, Demiralp B, Tozum TF, Nohutcu RM. ABM/P-15 modulates proliferation and mRNA synthesis of growth factors of periodontal ligament cells. Acta Odontol Scand. 2009;67(2):65-73. doi: 10.1080/00016350802555525.
- Results publication: PubMed 18938268Seo BM, Sonoyama W, Yamaza T, Coppe C, Kikuiri T, Akiyama K, Lee JS, Shi S. SHED repair critical-size calvarial defects in mice. Oral Dis. 2008 Jul;14(5):428-34. doi: 10.1111/j.1601-0825.2007.01396.x.
- Results publication: PubMed 20060336Kim YK, Kim SG, Byeon JH, Lee HJ, Um IU, Lim SC, Kim SY. Development of a novel bone grafting material using autogenous teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):496-503. doi: 10.1016/j.tripleo.2009.10.017. Epub 2010 Jan 8.
- Results publication: PubMed 22939321Kim YK, Kim SG, Yun PY, Yeo IS, Jin SC, Oh JS, Kim HJ, Yu SK, Lee SY, Kim JS, Um IW, Jeong MA, Kim GW. Autogenous teeth used for bone grafting: a comparison with traditional grafting materials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Jan;117(1):e39-45. doi: 10.1016/j.oooo.2012.04.018. Epub 2012 Aug 30.
- Results publication: PubMed 26795024Koga T, Minamizato T, Kawai Y, Miura K, I T, Nakatani Y, Sumita Y, Asahina I. Bone Regeneration Using Dentin Matrix Depends on the Degree of Demineralization and Particle Size. PLoS One. 2016 Jan 21;11(1):e0147235. doi: 10.1371/journal.pone.0147235. eCollection 2016.
- Results publicationBinderman, Itzhak, Gideon Hallel, Casap Nardy, Avinoam Yaffe, and Lari Sapoznikov.
- Results publication: PubMed 30578550Phillips DJ, Swenson DT, Johnson TM. Buccal bone thickness adjacent to virtual dental implants following guided bone regeneration. J Periodontol. 2019 Jun;90(6):595-607. doi: 10.1002/JPER.18-0304. Epub 2019 Jan 10.
- Results publication: PubMed 31529723Bertl K, Ebner M, Knibbe M, Pandis N, Kuchler U, Ulm C, Stavropoulos A. How old is old for implant therapy in terms of early implant losses? J Clin Periodontol. 2019 Dec;46(12):1282-1293. doi: 10.1111/jcpe.13199. Epub 2019 Nov 8.
- Individual participant dataSharing planned: No. Study records will be stored in a locked room and electronic records will be stored on an encrypted server, which meets the University IT Security requirements. Patient information will be kept within the University of Oklahoma. These records will be stored indefinitely on the server and available to copying and for future studies if requested under the supervision of a designated representative and in accordance with federal regulations.
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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.
Robin Henderson, DDS, MS principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Implant Placement in people with Edentulous Alveolar Ridge, run by University of Oklahoma 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 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. 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?
Results are not available in the source record.
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?
Implant Stability as Measured with ISQ values of implant (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT05219305, 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 16 Aug 2024.