A 1-year Clinical Investigation on the On1 Concept

• Register: ClinicalTrials.gov
• Last refreshed on: 8 February 2021
• Main ID: NCT03100448
• Date of registration: 28/02/2017
• Prospective Registration: No
• Primary sponsor: Nobel Biocare
• Public title: A 1-year Clinical Investigation on the On1 Concept T-190
• Scientific title: An Open, Prospective, Multi-center Study Evaluating the On1 Concept on NobelActive Implants
• Date of first enrolment: February 24, 2017
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03100448
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Italy, Lithuania, Netherlands

Contacts

• Name: Alina Gologan, DMD
• Affiliation: Nobel Bioacare

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Implant

Intervention(s)

Device: On1 Concept

Primary Outcome(s)

Marginal bone remodeling [Time Frame: 12 months]

Secondary Outcome(s)

Component Survival [Time Frame: 12 months]

Component Success [Time Frame: 12 months]

Patient's oral health related quality of life (OHIP-14) [Time Frame: 12 months]

Patient's pain perception (visual analogue score) [Time Frame: 3 months]

Ease of use of the On1 Concept (questionnaire) [Time Frame: 12 months]

Patient's satisfaction with function & esthetics (visual analogue score) [Time Frame: 12 months]

Soft tissue outcome (soft tissue height) [Time Frame: 12 months]

Secondary ID(s)

T-190

Source(s) of Monetary Support

Please refer to primary and secondary sponsors