A 1-year Clinical Investigation on the On1 Concept

NCT ID: NCT03100448

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-24
• Study Completion Date: 2019-05-08

Brief Summary

A 1-year Clinical Investigation on the On1 Concept.

Detailed 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.

Conditions

Implant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

On1 Concept

On1 Concept \& NobelActive implants

Group Type: OTHER

On1 Concept

Intervention Type: DEVICE

NobelActive implant placement with simultaneous On1 Base placement

Interventions

On1 Concept

NobelActive implant placement with simultaneous On1 Base placement

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Nobel Biocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alina Gologan, DMD

Role: STUDY_DIRECTOR

Nobel Bioacare

Locations

Service de Médecine dentaire CHU Sart Tilman

Liège, , Belgium

Studio Odontoiatrico Specialistico

Cattolica, , Italy

Dental Clinic Auksteja

Kaunas, LT, Lithuania

Dental Clinic Auksteja

Kaunas, , Lithuania

Vilnius Implantology Center

Vilnius, , Lithuania

Tandartspraktijk Staas & Bergmans

's-Hertogenbosch, , Netherlands

Countries

Belgium; Italy; Lithuania; Netherlands

Other Identifiers

T-190

Identifier Type: -

Identifier Source: org_study_id