Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)
Study Details
Study Description
Brief Summary
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)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Short Implant 17 patients will receive a 5 mm short implant. |
Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Placement of a short implant
|
| Other: Long Implant 17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. |
Device: Zimmer T3 with DCD Ex Hex Parallel Walled implants
Placement of a long implant with sinus lift and bone graft
|
Outcome Measures
Primary Outcome Measures
- Change in mesial-distal (M-D) bone loss [Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months]
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.
Secondary Outcome Measures
- Survival rate [5 month post-op, 12 month post-op, and 24 month post-op visits]
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.
- Number of sites with bleeding on probing [5 month post-op, 12 month post-op, and 24 month post-op visits]
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.
- Probing pocket depth [5 month post-op, 12 month post-op, and 24 month post-op visits]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 20-70 years at enrollment
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Systemically healthy patients
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Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth)
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In need of one premolar or 1st molar dental implant in the maxillary area
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Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.
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Presence of natural tooth/teeth, partial prosthesis and/or implants in the opposite jaw in contact with the planned crown/s deemed by the investigator as likely to present an initially stable implant situation
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Residual bone height under the maxillary sinus between 5 to 7 mm and a width of at least 7 mm, as measured on cone beam computer tomography (CBCT) scans.
Exclusion Criteria:
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Unlikely to be able to comply with study procedures
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Uncontrolled pathologic processes in the oral cavity
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History of head and neck chemotherapy within 5 years prior to surgery
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Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
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Uncontrolled diabetes mellitus HbA1c >8
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Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration
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Smokes more than 10 cigarettes/day
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Bruxer
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Present alcohol and/or drug abuser
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Pregnant, unsure pregnancy status, or lactating females (self-reported)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan School of Dentistry | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
Investigators
- Principal Investigator: Tae-Ju Oh, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
- Anitua E, Alkhraist MH, Piñas L, Begoña 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.
- Anitua E, Piñas 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.
- Buser D, Janner SF, Wittneben JG, Brägger 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.
- Chappuis V, Araújo 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. Review.
- 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. Review.
- Garaicoa-Pazmiño C, Suárez-López 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. Review.
- Lemos CA, Ferro-Alves ML, Okamoto R, Mendonça 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. Review.
- 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.
- 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.
- Schneider CA, Rasband WS, Eliceiri KW. NIH Image to ImageJ: 25 years of image analysis. Nat Methods. 2012 Jul;9(7):671-5.
- 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. Epub 2007 Jun 21.
- 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.
- Thoma DS, Haas R, Sporniak-Tutak K, Garcia A, Taylor TD, Hämmerle 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.
- HUM00151047