4 mm Implants in Fixed Cross-Arch Prostheses

NCT02877433 | Completed

• 1 other identifier: CR 03/15
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 2

Brief 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 short implants as distal support and two interforaminal implants of conventional length.

Conditions

Jaw Edentulous

Keywords

Small diameter implant; Cross-arch prostheses

Outcome Measures

Primary Outcomes (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)

  12 months after baseline

Secondary Outcomes (3)

• Implant success will be evaluated according to Buser

  12 and 36 months after baseline

• Prosthetic survival & success

  12 and 36 months after baseline

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

  12 and 36 months after baseline

Other Outcomes (1)

• Implant survival

  36 months after baseline

Study Arms (2)

Roxolid short implant, 4 mm length (4)

ACTIVE COMPARATOR

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)

Roxolid short implant, 4 mm length (2)

EXPERIMENTAL

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)

Interventions

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 (4)

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.

Roxolid short implant, 4 mm length (2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Straumann AG: lead

Study Sites (2)

University of Bern, Department of Reconstructive Dentistry and Gerodontology

Bern, 3010, Switzerland

Location

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

Belfast, BT9 7BL, United Kingdom

Location

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MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Julia-Gabriela Wittneben, Dr.

  University of Bern, Department of Reconstructive Dentistry and Gerodontology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2016
• First Posted: August 24, 2016
• Study Start: August 1, 2016
• Primary Completion: March 31, 2023
• Study Completion: November 13, 2025
• Last Updated: January 9, 2026

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); GB (1)