A 3-YEAR CLINICAL INVESTIGATION ON THE NOBEL ACTIVE® TIULTRA™ IMPLANT AND ON1™ BASE XEAL1™ _____________________________________________________________

Study Overview
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Brief Summary
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Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes

Official Title
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2017-1538: A 3-years Investigator Initiated Study to Evaluate the Soft Tissue Health and Stability in the Mandible and/or Maxilla Using the NobelActive® TiUltra™ and On1™ Base/Xeal™

Conditions
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to Study Soft Tissue Health and Stability

Intervention / Treatment
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* Device: NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: .The subject inclusion criteria are listed below. The subject is at least 18 years of age (or age of consent) and has passed cessation of growth. Obtained informed consent from the subject. The patient is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures). The subject shall be healthy and compliant with good oral hygiene. Full-mouth bleeding score (FMBS) lower than 25 %[10]. Full-mouth plaque score (FMPI) lower than 20% [11]. Suitable for implant treatment in the posterior, pre-molar area in the mandible or maxilla. The subject shall have a favorable and stable occlusal relationship. In need of one single tooth replacement Healed sites in need for implant placement (i.e. minimum of 6 weeks post extraction). The implant sites are free from infection and extraction remnants. The subject is suitable for a 1-stage surgical procedure. Sufficient amount of buccal and lingual keratinized mucosa. The healed sites eligible will have natural teeth as neighboring structures. The subject is in such a physical and mental condition that a 3-year follow up period can be carried out without foreseeable problems. The subject has a sufficient amount of bone for placing NobelActive TiUltra with a length of at least 7 mm. The following subject inclusion criteria apply at time of surgery: Primary implant stability as assessed by manual hand testing. Exclusion Criteria: The subject is not able to give her/his informed consent of participating. Health conditions, which do not permit the surgical (including anesthesia) or restorative procedure. Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or in subject history. Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation in the head/neck area. Infections in the planned implantation site or adjacent tissue. Acute, untreated periodontitis in the planned implantation site or adjacent tissue. Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc.). Uncontrolled diabetes, i.e. a subject with diagnosed diabetes that has a history of neglecting doctor's recommendations regarding treatment, food and alcohol intake or A1c level above 8%. Alcohol or drug abuse as noted in subject records or in subject history. Smoking less 10 cigarettes/day. Fresh extraction sites (up to 6 weeks). Severe bruxism or other destructive habits. Pregnant or lactating women at the time of implant insertion. Previous bone augmentation (lateral and/or vertical). Soft tissue augmentation less than 2 months before implant placement. Subject has allergic or adverse reactions to the restorative material

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components|The NobelActive® TiUltra™ implant is an ultra-hydrophilic multi-zone anodized implant surface. NobelActive® TiUltra™ features a gradual change in topography, from a minimally rough non-porous nanostructured implant collar to a moderately rough porous apex: more than roughness. NobelActive® TiUltra™ collar features surface chemistry and topography that promote early osseointegration and are designed to support bone stability. In addition, the Protective Layer preserves the pristine surface chemistry and hydrophilicity. The second new product is the Base/Xeal™ new surface, which is covered by a titanium oxide layer, created by electrochemical anodization of a titanium machined component, resulting in a yellow hue nano-structured surface.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 3-years Investigator initiated study to evaluate the soft tissue health and stability in the mandible and/or maxilla using the NobelActive® TiUltra™ and On1™ Base/Xeal™ | Soft tissue thickness, using IOS, between implant insertion (baseline) and 3-year follow-up has no changes | 47 months (8 months enrolment + 36 months follow up + 3 months study closure) |