A 1-year Clinical Investigation on the On1 Concept

Implant Clinical Trial

— T-190  

Official title:

An Open, Prospective, Multi-center Study Evaluating the On1 Concept on NobelActive Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03100448
• Other study ID #: T-190
• Status: Completed
• Phase: N/A
• Start date: February 24, 2017
• Est. completion date: May 8, 2019

Study information

• Verified date: October 2019
• Source: Nobel Biocare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A 1-year Clinical Investigation on the On1 Concept.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Implant

Intervention

Device:
• On1 Concept
NobelActive implant placement with simultaneous On1 Base placement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Nobel Biocare

Countries where clinical trial is conducted

Belgium,  Italy,  Lithuania,  Netherlands, 

Outcome

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