4 mm Implants in Fixed Cross-Arch Prostheses

November 20, 2023 updated by: Institut Straumann AG

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Bern, Switzerland, 3010
        • University of Bern, Department of Reconstructive Dentistry and Gerodontology
  • United Kingdom
      • Belfast, United Kingdom, BT9 7BL
        • Queens University Belfast, School of Medecine, Dentistry and Biomedical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Roxolid short implant, 4 mm length (4)
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Device: Roxolid short implant, 4 mm length (4)
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.
Experimental: Roxolid short implant, 4 mm length (2)
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Device: Roxolid short implant, 4 mm length (2)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: 12 months after baseline
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)
12 months after baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant success will be evaluated according to Buser
Time Frame: 12 and 36 months after baseline

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
12 and 36 months after baseline
Prosthetic survival & success
Time Frame: 12 and 36 months after baseline
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)
12 and 36 months after baseline
Crestal bone level change at the implant site (mesial and distal)
Time Frame: 12 and 36 months after baseline
Mesial and distal implant bone levels will be evaluated on a panoramic radiograph at baseline, 12 and 36 months after implant loading
12 and 36 months after baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant survival
Time Frame: 36 months after baseline
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)
36 months after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Straumann AG

Investigators

  • Principal Investigator: Julia-Gabriela Wittneben, Dr., University of Bern, Department of Reconstructive Dentistry and Gerodontology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

March 31, 2023

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimated)

August 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR 03/15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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