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

January 29, 2021 updated by: Nobel Biocare

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Marginal bone remodeling
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Soft tissue outcome (soft tissue height)
Time Frame: 12 months
The change in soft tissue height from baseline to 12-months of follow-up.
12 months
Component Survival
Time Frame: 12 months
Survival rates of implants as well as On1 components and prosthetics.
12 months
Component Success
Time Frame: 12 months
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)
Time Frame: 3 months
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)
Time Frame: 12 months
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)
Time Frame: 12 months
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)
Time Frame: 12 months
The ease of use of the On1 Concept is evaluated by the use of a surgeon questionnaire.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nobel Biocare

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alina Gologan, DMD, Nobel Bioacare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 1, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Implant

Clinical Trials on On1 Concept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings