Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm)

NCT ID: NCT04144322

Last Updated: 2025-05-06

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-14

Study Completion Date

2024-04-22

Brief Summary

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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)

Detailed Description

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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.

Conditions

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Bone Loss, Alveolar

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Short Implant

17 patients will receive a 5 mm short implant.

Group Type OTHER

Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition

Intervention Type DEVICE

Placement of a short implant

Long Implant

17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.

Group Type OTHER

Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants

Intervention Type DEVICE

Placement of a long implant with sinus lift and bone graft

Interventions

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Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition

Placement of a short implant

Intervention Type DEVICE

Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants

Placement of a long implant with sinus lift and bone graft

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age 20-70 years at enrollment
* Systemically healthy patients
* Full-mouth plaque score and full-mouth bleeding score ≤ 30% (measured at four sites per tooth)
* In need of one premolar or 1st molar dental implant in the maxillary area
* Neighboring teeth to the planned implant must have natural root(s) or implant supported restoration.
* 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
* 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

* Unlikely to be able to comply with study procedures
* Uncontrolled pathologic processes in the oral cavity
* History of head and neck chemotherapy within 5 years prior to surgery
* Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
* Uncontrolled diabetes mellitus HbA1c \>8
* Taking corticosteroids, IV bisphosphonates, or any other medication that could influence post-operative healing and/or osseointegration
* Smokes more than 10 cigarettes/day
* Bruxer
* Present alcohol and/or drug abuser
* Pregnant, unsure pregnancy status, or lactating females (self-reported)
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Tae-Ju Oh

Clinical Professor of Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tae-Ju Oh

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan School of Dentistry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24818208 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23656303 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22897683 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29114333 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28751181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26804969 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24444399 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27295262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28000281 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22930834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17590161 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22577959 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30341961 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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HUM00151047

Identifier Type: -

Identifier Source: org_study_id

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