Back to results4 mm Implants in Fixed Cross-Arch Prostheses
Primary Purpose
Jaw Edentulous
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Roxolid short implant, 4 mm length (4)
Roxolid short implant, 4 mm length (2)
Sponsored by
About this trial
This is an interventional other trial for Jaw Edentulous focused on measuring Small diameter implant, Cross-arch prostheses
Eligibility Criteria
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
Sites / Locations
- University of Bern, Department of Reconstructive Dentistry and Gerodontology
- Queens University Belfast, School of Medecine, Dentistry and Biomedical Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Roxolid short implant, 4 mm length (4)
Roxolid short implant, 4 mm length (2)
Arm Description
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02877433
Brief Title
4 mm Implants in Fixed Cross-Arch Prostheses
Official Title
Clinical Performance of 4 mm Short Distal Implants in Fixed Cross-Arch Prostheses - An Open, Randomized, Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 2016 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Straumann AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Jaw Edentulous
Keywords
Small diameter implant, Cross-arch prostheses
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Roxolid short implant, 4 mm length (4)
Arm Type
Active Comparator
Arm Description
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Arm Title
Roxolid short implant, 4 mm length (2)
Arm Type
Experimental
Arm Description
Straumann Tissue Level Ø4.1 mm RN SLActive Roxolid Standard Plus Implants available in lengths 4mm, 10mm, 12mm and 14mm
Intervention Type
Device
Intervention Name(s)
Roxolid short implant, 4 mm length (4)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Roxolid short implant, 4 mm length (2)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Implant survival
Description
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)
Time Frame
12 months after baseline
Secondary Outcome Measure Information:
Title
Implant success will be evaluated according to Buser
Description
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
Time Frame
12 and 36 months after baseline
Title
Prosthetic survival & success
Description
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)
Time Frame
12 and 36 months after baseline
Title
Crestal bone level change at the implant site (mesial and distal)
Description
Mesial and distal implant bone levels will be evaluated on a panoramic radiograph at baseline, 12 and 36 months after implant loading
Time Frame
12 and 36 months after baseline
Other Pre-specified Outcome Measures:
Title
Implant survival
Description
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)
Time Frame
36 months after baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia-Gabriela Wittneben, Dr.
Organizational Affiliation
University of Bern, Department of Reconstructive Dentistry and Gerodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bern, Department of Reconstructive Dentistry and Gerodontology
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Queens University Belfast, School of Medecine, Dentistry and Biomedical Sciences
City
Belfast
ZIP/Postal Code
BT9 7BL
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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4 mm Implants in Fixed Cross-Arch Prostheses
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