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Jaw EdentulousNCT02877433

4 mm Implants in Fixed Cross-Arch Prostheses

A study testing Roxolid short implant, 4 mm length (4) and Roxolid short implant, 4 mm length (2) in people with Jaw Edentulous, run by Institut Straumann AG at 2 sites in 2 countries.

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

This study aims to compare the clinical performance of 4 mm short implants supporting cross-arch fixed reconstructions in the edentulous mandible either with a combination of two short implants as distal support and two implants of conventional length placed in the interforaminal region, or with a combination of four… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Jaw Edentulous
What is being tested?
Roxolid short implant, 4 mm length (4) and Roxolid short implant, 4 mm length (2)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
2 sitesin 2 countries
Study dates
Aug 2016to 13 Nov 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females with at least 18 years of age (including 18 years)
  • Subject must have voluntarily signed the informed consent, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
  • Fully edentulous (latest extraction in the mandible should be performed at least 12 weeks before implant placement) that can be restored with a complete denture
  • Atrophic jaw bone in the posterior area, sufficient bone height and width to permit insertion of four short implants, 4 mm in regions of the first molar and second premolar on both sides and two standard length implants in the canine region

Who cannot join

  • Patients with inadequate bone volume and/or quality
  • Uncontrolled systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes)
  • Any contraindications for oral surgical procedures
  • History of local irradiation therapy in the head / neck area
  • Patients who smoke >10 cigarettes per day or tobacco equivalents, chew tobacco or have ≥ 20 pack years
  • Medical conditions requiring chronic high dose steroid therapy or high dose anti-resorptive treatment
Show all 19Show fewer
  • Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study
  • Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
  • Cognitive impairment that would interfere with the ability to perform adequate oral hygiene (assessed by the Ottawa 3DY scale)
  • Patients with chronic pain
  • Patients with HIV and/ or Hepatitis infection
  • Severe bruxing or clenching habits
  • Patients with inadequate oral hygiene or unmotivated for adequate home care (Denture Plaque Index (DPI) ≥ 5)
  • Patients with drug or alcohol abuse
  • Patients with allergies or hypersensitivity to chemical ingredients of titanium-zirconium alloy
  • Major simultaneous augmentation procedures. Dehiscence of a vertical distance of more than 3 mm
  • A woman who is pregnant or planning to become pregnant at any point during the study duration
  • Secondary Exclusion Criteria:
  • Patients with inadequate bone volume and/or quality

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

Switzerland1 site

  • University of Bern, Department of Reconstructive Dentistry and Gerodontology

    Bern, 3010

Other trials in Switzerland

United Kingdom1 site

  • Queens University Belfast, School of Medecine, Dentistry and Biomedical Sciences

    Belfast, BT9 7BL

Other trials in United Kingdom

About this study

Official title: Clinical Performance of 4 mm Short Distal Implants in Fixed Cross-Arch Prostheses - An Open, Randomized, Controlled Study

This study aims to compare the clinical performance of 4 mm short implants supporting cross-arch fixed reconstructions in the edentulous mandible either with a combination of two short implants as distal support and two implants of conventional length placed in the interforaminal region, or with a combination of four short implants as distal support and two interforaminal implants of conventional length.

Read the detailed description

This is a post-market, multi-center, prospective, open, randomized controlled clinical study. The total study duration for each patient should be 36 ± 2 months.

Roxolid Standard Plus Implants, 4 mm, Ø 4.1 mm, SLActive will be placed in positions 36/46 or 35/45, 36/46.

Roxolid Standard Plus Implants, Ø 4.1 mm, SLActive, in lengths of 10, 12 and 14 mm will be placed in positions 33/43.

In total 10 visits per patient are scheduled in this study. Implant survival, implant success, prosthetic survival and success, and adverse events (AEs) will be assessed.

All products are CE-(Conformité Européenne, meaning European Conformity) marked and used within its intended use.

Two centers in Switzerland and Northern Ireland will participate. The study and any amendments will be performed according to International Organization for Standardization (ISO) 14155:2011, local legal and regulatory requirements and conform to the Declaration of Helsinki (last revision Fortaleza 2013)

Conditions
Jaw Edentulous
Being tested
Roxolid short implant, 4 mm length (4), Roxolid short implant, 4 mm length (2)
Keywords
Small diameter implant, Cross-arch prostheses
Medical subject headings
Jaw, Edentulous

What participants receive

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

  • Roxolid short implant, 4 mm length (4)Device

    Placement of a combination of four short implants (in positions 35/45, 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.

  • Roxolid short implant, 4 mm length (2)Device

    Placement of a combination of two short implants (in positions 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.

Study groups in NCT02877433
Study groupRoleWhat they receive
Roxolid short implant, 4 mm length (4)Active comparatorStraumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Receives: Device: Roxolid short implant, 4 mm length (4)
Roxolid short implant, 4 mm length (2)ExperimentalStraumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Receives: Device: Roxolid short implant, 4 mm length (2)

What is being measured

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

  1. Implant survival

    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: 12 months after baseline

Secondary outcomes (3)

  1. Implant success will be evaluated according to Buser

    A particular implant will be considered successful if all of the following success criteria according to Buser et al. (Buser et al. 1991) apply:

    • Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)
    • Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics)
    • Absence of implant mobility on manual palpation
    • Absence of any continuous peri-implant radiolucency

    Measured: 12 and 36 months after baseline

  2. Prosthetic survival & success

    During the prosthodontic examination, the implant supported prostheses will be examined for any complications and failures as adapted from the ITI Treatment Guide Volume 8 (Brägger \& Heitz-Mayfield 2015)

    Measured: 12 and 36 months after baseline

  3. Crestal bone level change at the implant site (mesial and distal)

    Mesial and distal implant bone levels will be evaluated on a panoramic radiograph at baseline, 12 and 36 months after implant loading

    Measured: 12 and 36 months after baseline

Timeline

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

  1. First posted24 Aug 2016 (estimated)
  2. Study startAug 2016
  3. Primary completion31 Mar 2023
  4. Study completion13 Nov 2025

Resources

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
53 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02877433
Sponsor's protocol ID
CR 03/15
Status last verified
Jul 2024
First submitted
15 Aug 2016
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Albrektsson T, Zarb GA. Current interpretations of the osseointegrated response: clinical significance. Int J Prosthodont. 1993 Mar-Apr;6(2):95-105.

    PubMed 8329101

  • Allen F, Locker D. A modified short version of the oral health impact profile for assessing health-related quality of life in edentulous adults. Int J Prosthodont. 2002 Sep-Oct;15(5):446-50.

    PubMed 12375458

  • Ambjornsen E, Valderhaug J, Norheim PW, Floystrand F. Assessment of an additive index for plaque accumulation on complete maxillary dentures. Acta Odontol Scand. 1982;40(4):203-8. doi: 10.3109/00016358209019813.

    PubMed 6958165

  • Annibali S, Cristalli MP, Dell'Aquila D, Bignozzi I, La Monaca G, Pilloni A. Short dental implants: a systematic review. J Dent Res. 2012 Jan;91(1):25-32. doi: 10.1177/0022034511425675. Epub 2011 Oct 27.

    PubMed 22034499

  • Benzing U, Weber H, Simonis A, Engel E. Changes in chewing patterns after implantation in the edentulous mandible. Int J Oral Maxillofac Implants. 1994 Mar-Apr;9(2):207-13.

    PubMed 8206557

  • Brennan M, Houston F, O'Sullivan M, O'Connell B. Patient satisfaction and oral health-related quality of life outcomes of implant overdentures and fixed complete dentures. Int J Oral Maxillofac Implants. 2010 Jul-Aug;25(4):791-800.

    PubMed 20657876

  • Buser D, Weber HP, Bragger U, Balsiger C. Tissue integration of one-stage ITI implants: 3-year results of a longitudinal study with Hollow-Cylinder and Hollow-Screw implants. Int J Oral Maxillofac Implants. 1991 Winter;6(4):405-12.

    PubMed 1820309

  • Carlsson GE, Lindquist LW. Ten-year longitudinal study of masticatory function in edentulous patients treated with fixed complete dentures on osseointegrated implants. Int J Prosthodont. 1994 Sep-Oct;7(5):448-53.

    PubMed 7802913

  • de Grandmont P, Feine JS, Tache R, Boudrias P, Donohue WB, Tanguay R, Lund JP. Within-subject comparisons of implant-supported mandibular prostheses: psychometric evaluation. J Dent Res. 1994 May;73(5):1096-104. doi: 10.1177/00220345940730051201.

    PubMed 8006237

  • Hamdan NM, Gray-Donald K, Awad MA, Johnson-Down L, Wollin S, Feine JS. Do implant overdentures improve dietary intake? A randomized clinical trial. J Dent Res. 2013 Dec;92(12 Suppl):146S-53S. doi: 10.1177/0022034513504948. Epub 2013 Oct 24.

    PubMed 24158335

  • Heydecke G, Locker D, Awad MA, Lund JP, Feine JS. Oral and general health-related quality of life with conventional and implant dentures. Community Dent Oral Epidemiol. 2003 Jun;31(3):161-8. doi: 10.1034/j.1600-0528.2003.00029.x.

    PubMed 12752541

  • Ikebe K, Matsuda K, Morii K, Furuya-Yoshinaka M, Nokubi T, Renner RP. Association of masticatory performance with age, posterior occlusal contacts, occlusal force, and salivary flow in older adults. Int J Prosthodont. 2006 Sep-Oct;19(5):475-81.

    PubMed 17323726

  • John MT, Patrick DL, Slade GD. The German version of the Oral Health Impact Profile--translation and psychometric properties. Eur J Oral Sci. 2002 Dec;110(6):425-33. doi: 10.1034/j.1600-0722.2002.21363.x.

    PubMed 12507215

  • Millwood J, Heath MR. Food choice by older people: the use of semi-structured interviews with open and closed questions. Gerodontology. 2000 Jul;17(1):25-32. doi: 10.1111/j.1741-2358.2000.00025.x.

    PubMed 11203509

  • Mombelli A, van Oosten MA, Schurch E Jr, Land NP. The microbiota associated with successful or failing osseointegrated titanium implants. Oral Microbiol Immunol. 1987 Dec;2(4):145-51. doi: 10.1111/j.1399-302x.1987.tb00298.x. No abstract available.

    PubMed 3507627

Questions about this trial

What is this clinical trial studying?

A study testing Roxolid short implant, 4 mm length (4) and Roxolid short implant, 4 mm length (2) in people with Jaw Edentulous, run by Institut Straumann AG at 2 sites in 2 countries.

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 4 inclusion and 19 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 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Switzerland, United Kingdom. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Implant survival (time frame: 12 months after baseline). 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 NCT02877433, which also lists 28 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 9 Jan 2026.

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