Bone Loss, AlveolarNCT04144322

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

A study testing Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition and Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants in people with Bone Loss, Alveolar, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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) Read more about this study

Who is it for?: Ages 20 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Bone Loss, Alveolar
What is being tested?: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition and Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 14 Oct 2019to 22 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Show all 10Show fewer

Smokes more than 10 cigarettes/day
Bruxer
Present alcohol and/or drug abuser
Pregnant, unsure pregnancy status, or lactating females (self-reported)

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

Official title: Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial

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)

Read the 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.

Conditions: Bone Loss, Alveolar
Being tested: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition, Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants
Medical subject headings: Alveolar Bone Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zimmer T3 Short Ex Hex With Discrete Crystalline DepositionDevice
Placement of a short implant
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implantsDevice
Placement of a long implant with sinus lift and bone graft

Study groups in NCT04144322
Study group	Role	What they receive
Short Implant	Other	17 patients will receive a 5 mm short implant. Receives: Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition
Long Implant	Other	17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant. Receives: Device: Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months

Secondary outcomes (3)

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.
Measured: 5 month post-op, 12 month post-op, and 24 month post-op visits
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.
Measured: 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.
Measured: 5 month post-op, 12 month post-op, and 24 month post-op visits

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Oct 201922 Apr 2024

First posted30 Oct 2019
Study start14 Oct 2019
Primary completion22 Apr 2024
Study completion22 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Bone Loss, AlveolarStudies of the same condition, open and under way.
More trials run by University of MichiganThe 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04144322
Sponsor's protocol ID: HUM00151047
Status last verified: May 2025
First submitted: 28 Oct 2019
Last updated: 6 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Undecided

Publications

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.
PubMed 24818208
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.
PubMed 23656303
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.
PubMed 22897683
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.
PubMed 29114333
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.
PubMed 28751181
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.
PubMed 26804969
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.
PubMed 24444399
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.
PubMed 27295262
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.
PubMed 28000281
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.
PubMed 22930834
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.
PubMed 17590161
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.
PubMed 22577959
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.
PubMed 30341961

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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Recruiting
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All Bone Loss, Alveolar trials

Study at a glance

From the registry record, last updated by the sponsor on 6 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short Dental Implants (5 mm) Versus Long Dental Implants (10 mm) in Combination With Sinus Floor Elevation: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT04144322
Acronym / sponsor ID: HUM00151047
Conditions: Bone Loss, Alveolar
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 14 Oct 2019 (actual)
Primary completion: 22 Apr 2024 (actual)
Study completion: 22 Apr 2024 (actual)
First posted: 30 Oct 2019 (actual)
Results: Posted 6 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Short Implant	Other	Device: Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition17 patients will receive a 5 mm short implant.
Long Implant	Other	Device: Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implants17 patients will receive a sinus lift procedure, bone graft, and 10 mm implant.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (10 listed)

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

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
Zimmer T3 Short Ex Hex With Discrete Crystalline DepositionPlacement of a short implant	Device	Short Implant
Zimmer T3 with Discrete Crystalline Deposition Ex Hex Parallel Walled implantsPlacement of a long implant with sinus lift and bone graft	Device	Long Implant

Primary outcome

Change in Mesial-distal (M-D) Bone Loss
Time frame: 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.

3 secondary outcomes

Survival Rate
Time frame: 5 month post-op, 12 month post-op, and 24 month post-op visits
Number of Sites With Bleeding on Probing
Time frame: 5 month post-op, 12 month post-op, and 24 month post-op visits
Probing Pocket Depth
Time frame: 5 month post-op, 12 month post-op, and 24 month post-op visits

Results and safety

Results posted to the registry on 6 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Short Implant	17	15
Long Implant	17	15

Primary outcome: Change in Mesial-distal (M-D) Bone Loss

Time frame: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months. Mean (Standard Deviation). Unit: millimeters

Measure	Short Implant n = 15	Long Implant n = 15
Surgery visit	0.63 (0.38)	0.61 (0.57)
4 months (second stage)	-0.41 (0.76)	-0.40 (1.04)
5 months (loading)	-0.55 (0.83)	-0.64 (0.75)
12 months	-0.74 (0.79)	-0.40 (0.57)
24 months	-0.84 (0.62)	-059 (0.65)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected during each subject's entire participation in the study (approximately 2 years). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Short Implant	2 of 17 (11.8%)	0 of 17 (0%)	0 of 17
Long Implant	3 of 17 (17.6%)	0 of 17 (0%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 24818208Anitua 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.
Background: PubMed 23656303Anitua 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.
Background: PubMed 22897683Buser 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.
Background: PubMed 29114333Sargozaie 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.
Background: PubMed 28751181Pieri 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.
Background: PubMed 26804969Lemos 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.
Background: PubMed 24444399Garaicoa-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.
Background: PubMed 27295262Fan 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.
Background: PubMed 28000281Chappuis 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.
Background: PubMed 22930834Schneider 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.
Background: PubMed 17590161Strietzel 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.
Background: PubMed 22577959Telleman 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.
Individual participant dataSharing planned: Undecided

Related trials for Bone Loss, Alveolar

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L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
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Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
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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.

Tae-Ju Oh principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 10 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: finished, as of the sponsor's last update on 6 May 2025. 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?

Yes. Results are posted in the registry (first posted 6 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in Mesial-distal (M-D) Bone Loss (time frame: Baseline, surgical visit 1 day, 4 months, 5 months, 12 months, 24 months). 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 NCT04144322, which also lists 13 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 6 May 2025.