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

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

A 1-year Clinical Investigation on the On1 Concept.

Study Overview

• Status: Completed
• Conditions: Implant
• Intervention / Treatment: Device: 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.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Liege, Belgium, 4000
    • Service de Médecine dentaire CHU Sart Tilman
• Italy
  • Cattolica, Italy, 47841
    • Studio Odontoiatrico Specialistico
• Lithuania
  • Kaunas, Lithuania, 44275
    • Dental Clinic Auksteja
  • Vilnius, Lithuania, 01205
    • Vilnius Implantology Center
  • LT
    • Kaunas, LT, Lithuania, 44275
      • Dental Clinic Auksteja
• Netherlands
  • Hertogenbosch, Netherlands, 5216
    • Tandartspraktijk Staas & Bergmans

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: On1 Concept; On1 Concept & NobelActive implants	Device: On1 Concept; NobelActive implant placement with simultaneous On1 Base placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Soft tissue outcome (soft tissue height)	The change in soft tissue height from baseline to 12-months of follow-up.	12 months
Component Survival	Survival rates of implants as well as On1 components and prosthetics.	12 months
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Nobel Biocare
• Investigators: Study Director: Alina Gologan, DMD, Nobel Bioacare

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): May 8, 2019
• Study Completion (Actual): May 8, 2019

Study Registration Dates

• First Submitted: February 28, 2017
• First Submitted That Met QC Criteria: March 29, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: T-190

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No