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The purpose of this study is to evaluate the survival rate of 5 mm short implants compared to longer implants (10 mm) placed in sinus-grafted sites.
Primary aim: Compare bone loss between the two groups Secondary aim: Compare surgical time and patient-reported outcomes (satisfaction and post-operative pain)
34 patients requiring an implant to replace an upper missing tooth in the premolar or 1st molar area with a bone crest height from 5 to 8 mm will be recruited for this trial. Patients will be randomized to either the test (5-mm implant) or control group (10-mm implant) using a computer-generated randomization list . 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant while the other 17 patients will receive a 5 mm short implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Implant | Other | 17 patients will receive a 5 mm short implant. |
|
| Long Implant | Other | 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition | Device | Placement of a short implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mesial-distal (M-D) Bone Loss | Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits. | Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Survival Rate | The survival rate of the two groups will be recorded as a percentage at the 5 month post-op, 12 month post-op, and 24 month post-op visits based on clinician assessment. | 5 month post-op, 12 month post-op, and 24 month post-op visits |
| Number of Sites With Bleeding on Probing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tae-Ju Oh | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Dentistry | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24818208 | Background | Anitua E, Alkhraist MH, Pinas L, Begona L, Orive G. Implant survival and crestal bone loss around extra-short implants supporting a fixed denture: the effect of crown height space, crown-to-implant ratio, and offset placement of the prosthesis. Int J Oral Maxillofac Implants. 2014 May-Jun;29(3):682-9. doi: 10.11607/jomi.3404. | |
| 23656303 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Short Implant | 17 patients will receive a 5 mm short implant. Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant |
| FG001 | Long Implant | 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Short Implant | 17 patients will receive a 5 mm short implant. Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant |
| BG001 | Long Implant | 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Mesial-distal (M-D) Bone Loss | Comparing mesial-distal (M-D) bone loss between the two groups. This will be measured in millimeters using standardized radiographs of the implant site at the screening visit, surgical visit, 4 months post-op, 5 months post-op, 12 months post-op, and 24 months post-op visits. | Posted | Mean | Standard Deviation | millimeters | Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months |
|
Adverse event data was collected during each subject's entire participation in the study (approximately 2 years)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Short Implant | 17 patients will receive a 5 mm short implant. Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition: Placement of a short implant |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | Non-systematic Assessment | Subject noted having some gastrointestinal discomfort earlier that week before their baseline surgery. The next day, the subject notified one of the co-investigators that they had to go to the hospital for emergency surgery to remove their appendix. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tae-Ju Oh | University of Michigan | 7346473320 | taejuoh@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 6, 2022 | Apr 14, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 14, 2021 | Apr 14, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
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| Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants | Device | Placement of a long implant with sinus lift and bone graft |
|
The number of sites with bleeding on probing will be compared between the two groups. Bleeding on probing of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits. |
| 5 month post-op, 12 month post-op, and 24 month post-op visits |
| Probing Pocket Depth | The probing pocket depths will be compared between the two groups. Probing depths of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits. | 5 month post-op, 12 month post-op, and 24 month post-op visits |
| Anitua E, Pinas L, Orive G. Retrospective study of short and extra-short implants placed in posterior regions: influence of crown-to-implant ratio on marginal bone loss. Clin Implant Dent Relat Res. 2015 Feb;17(1):102-10. doi: 10.1111/cid.12073. Epub 2013 May 8. |
| 22897683 | Background | Buser D, Janner SF, Wittneben JG, Bragger U, Ramseier CA, Salvi GE. 10-year survival and success rates of 511 titanium implants with a sandblasted and acid-etched surface: a retrospective study in 303 partially edentulous patients. Clin Implant Dent Relat Res. 2012 Dec;14(6):839-51. doi: 10.1111/j.1708-8208.2012.00456.x. |
| 29114333 | Background | Sargozaie N, Moeintaghavi A, Shojaie H. Comparing the Quality of Life of Patients Requesting Dental Implants Before and After Implant. Open Dent J. 2017 Aug 31;11:485-491. doi: 10.2174/1874210601711010485. eCollection 2017. |
| 28751181 | Background | Pieri F, Forlivesi C, Caselli E, Corinaldesi G. Short implants (6mm) vs. vertical bone augmentation and standard-length implants (>/=9mm) in atrophic posterior mandibles: a 5-year retrospective study. Int J Oral Maxillofac Surg. 2017 Dec;46(12):1607-1614. doi: 10.1016/j.ijom.2017.07.005. Epub 2017 Jul 24. |
| 26804969 | Background | Lemos CA, Ferro-Alves ML, Okamoto R, Mendonca MR, Pellizzer EP. Short dental implants versus standard dental implants placed in the posterior jaws: A systematic review and meta-analysis. J Dent. 2016 Apr;47:8-17. doi: 10.1016/j.jdent.2016.01.005. Epub 2016 Jan 19. |
| 24444399 | Background | Garaicoa-Pazmino C, Suarez-Lopez del Amo F, Monje A, Catena A, Ortega-Oller I, Galindo-Moreno P, Wang HL. Influence of crown/implant ratio on marginal bone loss: a systematic review. J Periodontol. 2014 Sep;85(9):1214-21. doi: 10.1902/jop.2014.130615. Epub 2014 Jan 20. |
| 27295262 | Background | Fan T, Li Y, Deng WW, Wu T, Zhang W. Short Implants (5 to 8 mm) Versus Longer Implants (>8 mm) with Sinus Lifting in Atrophic Posterior Maxilla: A Meta-Analysis of RCTs. Clin Implant Dent Relat Res. 2017 Feb;19(1):207-215. doi: 10.1111/cid.12432. Epub 2016 Jun 13. |
| 28000281 | Background | Chappuis V, Araujo MG, Buser D. Clinical relevance of dimensional bone and soft tissue alterations post-extraction in esthetic sites. Periodontol 2000. 2017 Feb;73(1):73-83. doi: 10.1111/prd.12167. |
| 22930834 | Background | Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5. doi: 10.1038/nmeth.2089. |
| 17590161 | Background | Strietzel FP, Reichart PA. Oral rehabilitation using Camlog screw-cylinder implants with a particle-blasted and acid-etched microstructured surface. Results from a prospective study with special consideration of short implants. Clin Oral Implants Res. 2007 Oct;18(5):591-600. doi: 10.1111/j.1600-0501.2007.01375.x. Epub 2007 Jun 21. |
| 22577959 | Background | Telleman G, Raghoebar GM, Vissink A, Meijer HJ. Impact of platform switching on peri-implant bone remodeling around short implants in the posterior region, 1-year results from a split-mouth clinical trial. Clin Implant Dent Relat Res. 2014 Feb;16(1):70-80. doi: 10.1111/j.1708-8208.2012.00461.x. Epub 2012 May 11. |
| 30341961 | Background | Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Hammerle CHF. Randomized controlled multicentre study comparing short dental implants (6 mm) versus longer dental implants (11-15 mm) in combination with sinus floor elevation procedures: 5-Year data. J Clin Periodontol. 2018 Dec;45(12):1465-1474. doi: 10.1111/jcpe.13025. Epub 2018 Nov 25. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Soft tissue phenotype | Count of Participants | Participants |
|
| Bone density | Subjective evaluation of the bone type (Lekholm & Zarb 1985) during implant site preparation performed by the surgeon.
| Count of Participants | Participants |
|
| Residual ridge height | Mean | Standard Deviation | millimeters |
|
|
|
| Secondary | Survival Rate | The survival rate of the two groups will be recorded as a percentage at the 5 month post-op, 12 month post-op, and 24 month post-op visits based on clinician assessment. | Posted | Count of Participants | Participants | 5 month post-op, 12 month post-op, and 24 month post-op visits |
|
|
|
| Secondary | Number of Sites With Bleeding on Probing | The number of sites with bleeding on probing will be compared between the two groups. Bleeding on probing of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits. | Posted | Mean | Standard Deviation | implant sites | 5 month post-op, 12 month post-op, and 24 month post-op visits |
|
|
|
| Secondary | Probing Pocket Depth | The probing pocket depths will be compared between the two groups. Probing depths of the implant site will be measured with a periodontal probe at the 5 month post-op, 12 month post-op, and 24 month post-op visits. | Posted | Mean | Standard Deviation | millimeters | 5 month post-op, 12 month post-op, and 24 month post-op visits |
|
|
|
| 0 |
| 17 |
| 2 |
| 17 |
| 0 |
| 17 |
| EG001 | Long Implant | 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants: Placement of a long implant with sinus lift and bone graft | 0 | 17 | 3 | 17 | 0 | 17 |
|
| Coronavirus disease of 2019 and ablation | Cardiac disorders | Non-systematic Assessment | Subject contracted coronavirus disease of 2019 and was hospitalized for 10 days, then later needed to have a heart ablation. |
|
| Vehicle accident | Social circumstances | Non-systematic Assessment | Severe vehicle accident that required hospitalization. |
|
| Assault | Social circumstances | Non-systematic Assessment | Physically assaulted by someone which required physical therapy for many months. |
|
| Hip replacement | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D010510 |
| Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| Thick |
|
| Very Thick |
|
| D3 |
|
| D4 |
|
| 24 months |
|
| 24 months |
|
| 24 months |
|