Dental Implant Placement for Alveolar ridge
Phase-Based Progress Estimates
Effectiveness
Safety
Alveolar ridge+1 More
Dental Implant Placement - DeviceEligibility
18+
All Sexes
What conditions do you have?
Select
Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
This trial is testing whether or not two different types of bone grafts, mineralized and partially demineralized dentin grafts, are effective in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.
Eligible Conditions
- Alveolar ridge
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 0 Secondary · Reporting Duration: 6 months
6 months
Implant Failure Rate
Implant Stability as Measured with ISQ values of implant
Interproximal crestal bone level
Probing pocket depth
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Freeze-Dried Bone Allograft
1 of 3
Partially-demineralized tooth graft
1 of 3
mineralized tooth graft
1 of 3
Experimental Treatment
60 Total Participants · 3 Treatment Groups
Primary Treatment: Dental Implant Placement · No Placebo Group · N/A
Freeze-Dried Bone Allograft
Device
Experimental Group · 1 Intervention: Dental Implant Placement · Intervention Types: DevicePartially-demineralized tooth graft
Device
Experimental Group · 1 Intervention: Dental Implant Placement · Intervention Types: Devicemineralized tooth graft
Device
Experimental Group · 1 Intervention: Dental Implant Placement · Intervention Types: DeviceTrial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
Zimmer BiometIndustry Sponsor
358 Previous Clinical Trials
63,713 Total Patients Enrolled
University of OklahomaLead Sponsor
419 Previous Clinical Trials
97,010 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You have a well-controlled systemic disease.
You are able to understand and sign a written informed consent form and willing to fulfill all study requirements.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
Who else is applying?
What state do they live in?
| Oklahoma | 46.2% |
| Texas | 15.4% |
| North Carolina | 7.7% |
| Other | 30.8% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| University of Oklahoma College of Dentistry Graduate Periodontics | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 69.2% |
| Did not meet criteria | 30.8% |
How responsive is this trial?
Most responsive sites:
- University of Oklahoma College of Dentistry Graduate Periodontics: < 48 hours
Average response time
- < 2 Days
Typically responds via
| 100.0% | |
References
- Phillips, Daniel J., Dane T. Swenson, and Thomas M. Johnson. 2019. “Buccal Bone Thickness Adjacent to Virtual Dental Implants Following Guided Bone Regeneration”. Journal of Periodontology. Wiley. doi:10.1002/jper.18-0304.
- Emecen, Pinar, Abdullah Cevdet Akman, Sema Sezgin Hakki, Erdogan Esref Hakki, Burak Demiralp, Tolga Fikret Tözüm, and Rahime Meral Nohutcu. 2009. “ABM/P-15 Modulates Proliferation and Mrna Synthesis of Growth Factors of Periodontal Ligament Cells”. Acta Odontologica Scandinavica. Informa UK Limited. doi:10.1080/00016350802555525.
- Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.
- Murata, M. "Autogenous demineralized dentin matrix for maxillary sinus augmentation in human. The first clinical report." Journal of Dental Reseach., 82, B243.
- Saygin, N. Esra, Yoshihiko Tokiyasu, William V. Giannobile, and Martha J. Somerman. 2000. “Growth Factors Regulate Expression of Mineral Associated Genes in Cementoblasts”. Journal of Periodontology. Wiley. doi:10.1902/jop.2000.71.10.1591.
- Binderman, 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.
- Koga, Takamitsu, Tokutaro Minamizato, Yosuke Kawai, Kei-ichiro Miura, Takashi I, Yuya Nakatani, Yoshinori Sumita, and Izumi Asahina. 2016. “Bone Regeneration Using Dentin Matrix Depends on the Degree of Demineralization and Particle Size”. Edited by Gianpaolo Papaccio. Plos One. Public Library of Science (PLoS). doi:10.1371/journal.pone.0147235.
- Binderman, Itzhak, Gideon Hallel, Casap Nardy, Avinoam Yaffe, and Lari Sapoznikov.
- Kim, Young-Kyun, Su-Gwan Kim, Pil-Young Yun, In-Sung Yeo, Seung-Chan Jin, Ji-Su Oh, Heung-Joong Kim, et al.. 2014. “Autogenous Teeth Used for Bone Grafting: A Comparison with Traditional Grafting Materials”. Oral Surgery, Oral Medicine, Oral Pathology and Oral Radiology. Elsevier BV. doi:10.1016/j.oooo.2012.04.018.
- Korsch, M. 2021. “Tooth Shell Technique: A Proof of Concept with the Use of Autogenous Dentin Block Grafts”. Australian Dental Journal. Wiley. doi:10.1111/adj.12814.
- Bertl, Kristina, Maria Ebner, Marianne Knibbe, Nikolaos Pandis, Ulrike Kuchler, Christian Ulm, and Andreas Stavropoulos. 2019. “How Old Is Old for Implant Therapy in Terms of Early Implant Losses?”. Journal of Clinical Periodontology. Wiley. doi:10.1111/jcpe.13199.
- Kim, Young-Kyun, Su-Gwan Kim, Ju-Hee Byeon, Hyo-Jung Lee, In-Ung Um, Sung-Chul Lim, and Suk-Young Kim. 2010. “Development of a Novel Bone Grafting Material Using Autogenous Teeth”. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontology. Elsevier BV. doi:10.1016/j.tripleo.2009.10.017.
- Howe, Mark-Steven, William Keys, and Derek Richards. 2019. “Long-term (10-year) Dental Implant Survival: A Systematic Review and Sensitivity Meta-analysis”. Journal of Dentistry. Elsevier BV. doi:10.1016/j.jdent.2019.03.008.
- Jung, Ronald E., Nadine Fenner, Christoph H. F. Hämmerle, and Nicola U. Zitzmann. 2012. “Long-term Outcome of Implants Placed with Guided Bone Regeneration (GBR) Using Resorbable and Non-resorbable Membranes After 12-14 Years”. Clinical Oral Implants Research. Wiley. doi:10.1111/j.1600-0501.2012.02522.x.
- Seo, BM, W Sonoyama, T Yamaza, C Coppe, T Kikuiri, K Akiyama, JS Lee, and S Shi. 2008. “SHED Repair Critical-size Calvarial Defects in Mice”. Oral Diseases. Wiley. doi:10.1111/j.1601-0825.2007.01396.x.
- 2022. "Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05219305.
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