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

N

Nobel Biocare

Status

Completed

Conditions

Implant

Treatments

Device: On1 Concept

Study type

Interventional

Funder types

Industry

Identifiers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

72 participants in 1 patient group

On1 Concept
Other group
Description:
On1 Concept \& NobelActive implants
Treatment:
Device: On1 Concept

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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