Implant Clinical Trial
— T-190Official title:
An Open, Prospective, Multi-center Study Evaluating the On1 Concept on NobelActive Implants
NCT number | NCT03100448 |
Other study ID # | T-190 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 24, 2017 |
Est. completion date | May 8, 2019 |
Verified date | October 2019 |
Source | Nobel Biocare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A 1-year Clinical Investigation on the On1 Concept.
Status | Completed |
Enrollment | 72 |
Est. completion date | May 8, 2019 |
Est. primary completion date | May 8, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Service de Médecine dentaire CHU Sart Tilman | Liege | |
Italy | Studio Odontoiatrico Specialistico | Cattolica | |
Lithuania | Dental Clinic Auksteja | Kaunas | LT |
Lithuania | Dental Clinic Auksteja | Kaunas | |
Lithuania | Vilnius Implantology Center | Vilnius | |
Netherlands | Tandartspraktijk Staas & Bergmans | Hertogenbosch |
Lead Sponsor | Collaborator |
---|---|
Nobel Biocare |
Belgium, Italy, Lithuania, Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Marginal bone remodeling | The change in the marginal bone level around the implants from baseline to 12-months of follow-up is measured on paired radiographs. | 12 months | |
Secondary | Soft tissue outcome (soft tissue height) | The change in soft tissue height from baseline to 12-months of follow-up. | 12 months | |
Secondary | Component Survival | Survival rates of implants as well as On1 components and prosthetics. | 12 months | |
Secondary | Component Success | Success of implants as well as On1 components and prosthetics by clinical evaluation calculated in a cumulative success rate life table. | 12 months | |
Secondary | Patient's pain perception (visual analogue score) | The patient's pain perception during the post surgery period is evaluated by the use of a visual analogue score. | 3 months | |
Secondary | Patient's oral health related quality of life (OHIP-14) | The patient's oral health related quality of life is evaluated by the use of the OHIP-14 questionnaire. | 12 months | |
Secondary | Patient's satisfaction with function & esthetics (visual analogue score) | The patient's satisfaction with function & esthetics is evaluated by the use of a visual analogue score. | 12 months | |
Secondary | Ease of use of the On1 Concept (questionnaire) | The ease of use of the On1 Concept is evaluated by the use of a surgeon questionnaire. | 12 months |
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