4 mm Implants in Fixed Cross-Arch Prostheses

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

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

Conditions
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Jaw Edentulous

Intervention / Treatment
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* Device: Roxolid short implant, 4 mm length (4)
* Device: Roxolid short implant, 4 mm length (2)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Roxolid short implant, 4 mm length (4)<br>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)<br>* 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.<br>|
| Experimental: Roxolid short implant, 4 mm length (2)<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 12 and 36 months after baseline | 
| 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) | 12 and 36 months after baseline | 
| 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 | 12 and 36 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Small diameter implant, Cross-arch prostheses