Implant
Conditions
Brief summary
A 1-year Clinical Investigation on the On1 Concept.
Detailed description
This open, prospective, multi-center clinical trial evaluates the On1 Concept for the treatment of patients in need for single tooth replacement or 3-unit bridges in the mandible or maxilla.
Interventions
DEVICEOn1 Concept
NobelActive implant placement with simultaneous On1 Base placement
Sponsors
Nobel Biocare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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 and canine area in the mandible or maxilla. * The subject shall have a favorable and stable occlusal relationship. * In need of one or multiple single tooth replacements or 3-unit bridges. * 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 subject has a sufficient amount of bone for placing NobelActive implants with a length of at least 8 mm. * 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 of \>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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Marginal bone remodeling | 12 months | The change in the marginal bone level around the implants from baseline to 12-months of follow-up is measured on paired radiographs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Component Survival | 12 months | Survival rates of implants as well as On1 components and prosthetics. |
| Component Success | 12 months | Success of implants as well as On1 components and prosthetics by clinical evaluation calculated in a cumulative success rate life table. |
| Patient's pain perception (visual analogue score) | 3 months | The patient's pain perception during the post surgery period is evaluated by the use of a visual analogue score. |
| Soft tissue outcome (soft tissue height) | 12 months | The change in soft tissue height from baseline to 12-months of follow-up. |
| Patient's satisfaction with function & esthetics (visual analogue score) | 12 months | The patient's satisfaction with function & esthetics is evaluated by the use of a visual analogue score. |
| Ease of use of the On1 Concept (questionnaire) | 12 months | The ease of use of the On1 Concept is evaluated by the use of a surgeon questionnaire. |
| Patient's oral health related quality of life (OHIP-14) | 12 months | The patient's oral health related quality of life is evaluated by the use of the OHIP-14 questionnaire. |
Countries
Belgium, Italy, Lithuania, Netherlands
Outcome results
None listed