A 1-year Clinical Investigation on the On1 Concept (T-190)

Nobel Biocare

Status

Completed

Conditions

Implant

Treatments

Device: On1 Concept

Study type

Interventional

Funder types

Industry

Identifiers

NCT03100448

T-190

Details and patient eligibility

About

A 1-year Clinical Investigation on the On1 Concept.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.