Edentulous JawNCT03509402

Short vs Long Dental Implants for the Fixed Rehabilitation of the Fully Edentulous Mandible

A study testing ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm and ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm in people with Edentulous Jaw, run by University of Campania Luigi Vanvitelli.

Completed

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

Official record

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Trial summary

The aim of this study is to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants placed in the interforaminal region of fully edentulous mandibles, supporting a screw-retained full-arch cantilever bridge. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Edentulous Jaw
What is being tested?: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm and ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Jan 2010to Feb 2021
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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

total edentulous patients in the lower region since at least 8 months,
sufficient amount of native bone (no augmentation procedures) in the recipient sites to allow ≥11 mm long and 4 mm wide implant installation (≥1 mm of peri-implant bone circumferentially)
systemic health
compliance with good oral hygiene
informed consent signed.

Who cannot join

any disease, medication or drug that could jeopardize healing, osseointegration or treatment outcome,
untreated caries or periodontitis of the remaining teeth,
mucosal and bone tissue lesions,
severe bruxism or other parafunction habits,
unrealistic aesthetic demands,
patient taking part to another study

About this study

Official title: Short vs Long Implants Supporting a Total Fixed Prosthetic Rehabilitation of the Fully Edentulous Mandible. A Multicenter Randomized Controlled Clinical Trial

Read the detailed description

The use of short dental implants provides undeniable benefits in sites where the reduced available volume would otherwise need bone augmentation procedures and their use has greatly expanded in the recent years. However, well designed clinical trials which provide a sound evidence of their performance and reliability are still lacking to date.

In this post-market, multi-center, open, parallel-group, randomized, controlled clinical trial the investigators aim to to clinically and radiographically compare the performance of short (6 mm-long) versus long (≥11 mm-long) dental implants supporting a mandibular screw-retained full-arch cantilever bridge.

Five 4mm-wide/6mm-long (test) or 4mm-wide/≥11mm-long (control) titanium dental implants (Osseospeed™, ASTRA TECH Implant System™, Dentsply Sirona) are placed in the interforaminal region of fully edentulous mandibles, in non-regenerated sites, with at least 1 mm of peri-implant bone circumferentially.

All products are CE (European Conformity) marked and used within their intended use.

Two-Stage surgery is performed, implants are positioned in healed bone and exposed after 3 months to be connected with the prosthesis.

This is a medium-term follow-up study including evaluations also at 1 and 3 years from the baseline.

Three italian centers participate: Naples (University of Campania "Luigi Vanvitelli"), Naples (AORN "A. Cardarelli"), Catania (Private Office).

The study protocol has been approved by the Institutional Review Board of the University of Campania "Luigi Vanvitelli".

Conditions: Edentulous Jaw
Being tested: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm, ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm
Keywords: short dental implants, full-arch prosthesis
Medical subject headings: Jaw, Edentulous

What participants receive

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

ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mmDevice
Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mmDevice
Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)

Study groups in NCT03509402
Study group	Role	What they receive
Short implants	Experimental	A full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm) Receives: Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm
Long implants	Active comparator	A full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm) Receives: Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm

What is being measured

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

Marginal Bone Level (MBL) Change
Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders.
Measured: 5 years from baseline (prosthetic loading)

Secondary outcomes (4)

Implant Survival Rate
A surviving implant is defined as an implant in place at the time of the follow-up. Any implant loss shall be assessed as an early loss (implant fails before being osseointegrated) or late loss (after being osseointegrated).
Measured: 5 years from baseline (prosthetic loading)
Prosthesis Survival
A surviving prosthesis is defined as still in place at the time of the follow-up.
Measured: 5 years from baseline (prosthetic loading)
Biological Complications
Peri-implant mucositis and peri-implantitis
Measured: 5 years from baseline (prosthetic loading)
Technical Complications
Technical complications are categorized in minor and major complications. The formers require only chair-side repair and include screw loosening and veneer material fracture. The latters require additional laboratory procedures and/or replacement components and include prosthesis or framework fracture, screw fracture, implant fracture, and extended wear requiring veneer renewal.
Measured: 5 years from baseline (prosthetic loading)

Timeline

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

Jan 2010Feb 2021

First posted26 Apr 2018
Study startJan 2010
Primary completionFeb 2021
Study completionFeb 2021

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 (7)Papers the sponsor has linked to this study.
Other trials for Edentulous JawStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03509402
Sponsor's protocol ID: CEAOUSUN1327012010
Status last verified: Nov 2024
First submitted: 31 Mar 2018
Last updated: 13 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
PubMed 3527955
Nisand D, Renouard F. Short implant in limited bone volume. Periodontol 2000. 2014 Oct;66(1):72-96. doi: 10.1111/prd.12053.
PubMed 25123762
Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8.
PubMed 14714838
Srinivasan M, Vazquez L, Rieder P, Moraguez O, Bernard JP, Belser UC. Survival rates of short (6 mm) micro-rough surface implants: a review of literature and meta-analysis. Clin Oral Implants Res. 2014 May;25(5):539-45. doi: 10.1111/clr.12125. Epub 2013 Feb 18.
PubMed 23413956
Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x.
PubMed 19681932
Guida L, Annunziata M, Esposito U, Sirignano M, Torrisi P, Cecchinato D. 6-mm-short and 11-mm-long implants compared in the full-arch rehabilitation of the edentulous mandible: A 3-year multicenter randomized controlled trial. Clin Oral Implants Res. 2020 Jan;31(1):64-73. doi: 10.1111/clr.13547. Epub 2019 Oct 29.
PubMed 31605405
Guida L, Esposito U, Sirignano M, Torrisi P, Annunziata M, Cecchinato D. 6 mm short versus 11 mm long inter-foraminal implants in the full-arch rehabilitation of edentulous non-atrophic mandibles: 5-year results from a multicenter randomized controlled trial. Clin Oral Implants Res. 2023 Feb;34(2):127-136. doi: 10.1111/clr.14024. Epub 2022 Dec 13.
PubMed 36461704

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?

Official record

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All Edentulous Jaw trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short vs Long Implants Supporting a Total Fixed Prosthetic Rehabilitation of the Fully Edentulous Mandible. A Multicenter Randomized Controlled Clinical Trial
ClinicalTrials.gov ID: NCT03509402
Acronym / sponsor ID: CEAOUSUN1327012010
Conditions: Edentulous Jaw
Keywords: short dental implants, full-arch prosthesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: University of Campania Luigi VanvitelliUniversity, hospital or other
Collaborators: Dentsply Sirona Implants and Consumables
Study start: Jan 2010 (actual)
Primary completion: Feb 2021 (actual)
Study completion: Feb 2021 (actual)
First posted: 26 Apr 2018 (actual)
Results: Posted 13 Jan 2025

Clinical summary

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

Detailed description

All products are CE (European Conformity) marked and used within their intended use.

Two-Stage surgery is performed, implants are positioned in healed bone and exposed after 3 months to be connected with the prosthesis.

This is a medium-term follow-up study including evaluations also at 1 and 3 years from the baseline.

Three italian centers participate: Naples (University of Campania "Luigi Vanvitelli"), Naples (AORN "A. Cardarelli"), Catania (Private Office).

The study protocol has been approved by the Institutional Review Board of the University of Campania "Luigi Vanvitelli".

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Short implants	Experimental	Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mmA full-arch screw-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6mm)
Long implants	Active comparator	Device: ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mmA full-arch srew-retained mandibular prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

total edentulous patients in the lower region since at least 8 months,
sufficient amount of native bone (no augmentation procedures) in the recipient sites to allow ≥11 mm long and 4 mm wide implant installation (≥1 mm of peri-implant bone circumferentially)
systemic health
compliance with good oral hygiene
informed consent signed.

Key exclusion criteria (6 listed)

any disease, medication or drug that could jeopardize healing, osseointegration or treatment outcome,
untreated caries or periodontitis of the remaining teeth,
mucosal and bone tissue lesions,
severe bruxism or other parafunction habits,
unrealistic aesthetic demands,

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
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mmRehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)	Device	Short implants
ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mmRehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)	Device	Long implants

Primary outcome

Marginal Bone Level (MBL) Change
Time frame: 5 years from baseline (prosthetic loading)
Marginal bone level (MBL) is measured as the distance in millimiters calculated on periapical radiographs from the implant neck to the most coronal bone-to-implant contact point at both the mesial and the distal side of each implant. The radiographs will be taken with an X-ray apparatus supplied with a long cone and Rinn's film holders.

4 secondary outcomes

Implant Survival Rate
Time frame: 5 years from baseline (prosthetic loading)
Prosthesis Survival
Time frame: 5 years from baseline (prosthetic loading)
Biological Complications
Time frame: 5 years from baseline (prosthetic loading)
Technical Complications
Time frame: 5 years from baseline (prosthetic loading)

Results and safety

Results posted to the registry on 13 Jan 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 Implants	15	13
Long Implants	15	14

Primary outcome: Marginal Bone Level (MBL) Change

Time frame: 5 years from baseline (prosthetic loading). Mean (Standard Deviation). Unit: mm

Measure	Short Implants n = 13	Long Implants n = 14
Value	0.30 (0.31)	0.40 (0.23)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Short Implants	0 of 15 (0%)	0 of 15 (0%)	0 of 15
Long Implants	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 3527955Albrektsson T, Zarb G, Worthington P, Eriksson AR. The long-term efficacy of currently used dental implants: a review and proposed criteria of success. Int J Oral Maxillofac Implants. 1986 Summer;1(1):11-25. No abstract available.
Background: PubMed 25123762Nisand D, Renouard F. Short implant in limited bone volume. Periodontol 2000. 2014 Oct;66(1):72-96. doi: 10.1111/prd.12053.
Background: PubMed 14714838Ekelund JA, Lindquist LW, Carlsson GE, Jemt T. Implant treatment in the edentulous mandible: a prospective study on Branemark system implants over more than 20 years. Int J Prosthodont. 2003 Nov-Dec;16(6):602-8.
Background: PubMed 23413956Srinivasan M, Vazquez L, Rieder P, Moraguez O, Bernard JP, Belser UC. Survival rates of short (6 mm) micro-rough surface implants: a review of literature and meta-analysis. Clin Oral Implants Res. 2014 May;25(5):539-45. doi: 10.1111/clr.12125. Epub 2013 Feb 18.
Background: PubMed 19681932Laurell L, Lundgren D. Marginal bone level changes at dental implants after 5 years in function: a meta-analysis. Clin Implant Dent Relat Res. 2011 Mar;13(1):19-28. doi: 10.1111/j.1708-8208.2009.00182.x.
Results publication: PubMed 31605405Guida L, Annunziata M, Esposito U, Sirignano M, Torrisi P, Cecchinato D. 6-mm-short and 11-mm-long implants compared in the full-arch rehabilitation of the edentulous mandible: A 3-year multicenter randomized controlled trial. Clin Oral Implants Res. 2020 Jan;31(1):64-73. doi: 10.1111/clr.13547. Epub 2019 Oct 29.
Results publication: PubMed 36461704Guida L, Esposito U, Sirignano M, Torrisi P, Annunziata M, Cecchinato D. 6 mm short versus 11 mm long inter-foraminal implants in the full-arch rehabilitation of edentulous non-atrophic mandibles: 5-year results from a multicenter randomized controlled trial. Clin Oral Implants Res. 2023 Feb;34(2):127-136. doi: 10.1111/clr.14024. Epub 2022 Dec 13.

Related trials for Edentulous Jaw

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
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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.

Luigi Guida, Prof principal investigator

University of Campania Luigi Vanvitelli

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 5 inclusion and 6 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 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

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 13 Jan 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?

Marginal Bone Level (MBL) Change (time frame: 5 years from baseline (prosthetic loading)). 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 NCT03509402, which also lists 7 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 13 Jan 2025.