Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The TREFOIL Concept 5 Year Clinical Investigation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02940353
Recruitment Status : Active, not recruiting
First Posted : October 20, 2016
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Nobel Biocare

Tracking Information
First Submitted Date  ICMJE October 19, 2016
First Posted Date  ICMJE October 20, 2016
Last Update Posted Date May 11, 2018
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 20, 2016)
Cumulative survival rates for the implants [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
To evaluate the cumulative survival rates (CSR) of implants in the mandible for a period of 5 years. [ Time Frame: 5 years ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The TREFOIL Concept 5 Year Clinical Investigation
Official Title  ICMJE The TREFOIL Concept: A Clinical Investigation in the Mandible on 3 Implants With a Fixed Prefabricated Framework
Brief Summary Prospective, single cohort, multi-center study evaluating the TREFOIL concept for the treatment of edentulous or patients with failing mandibular dentition over 5 years. 90 patients (15 per centre) will be included. The subject population is at least 18 years old, in need of an implant restored full prosthesis providing sufficient bone in the interforaminal where a fixed restoration on three implants is regarded as an appropriate treatment solution. The components are TREFOIL treatment concept (implants and framework).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Edentulous or Failing Dentition Mandible
Intervention  ICMJE Device: TREFOIL concept
Study Arms  ICMJE Treatment with Trefoil concept
Treatment
Intervention: Device: TREFOIL concept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 7, 2018)
110
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2016)
90
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Obtained informed consent from the subject.
  • The subject is at least 18 years of age (passed cessation of growth) and not older than 80 years.
  • The subject is in such a physical and mental condition that a 5-year follow-up period can be carried out without foreseeable problems.
  • The subject fulfills the prerequisite that a harmonic, stable occlusal relationship can be achieved with opposing natural teeth resp. fixed or removable opposing dentition (tooth or implant based) or soft tissue born denture.
  • The subject is willing and able to comply with all study related procedures (such as exercising oral hygiene and attending all follow-up procedures).
  • The subject is compliant with good oral hygiene.
  • The subject has an edentulous mandible or failing mandibular dentition providing sufficient bone in the interforaminal where a fixed restoration on three (3) implants is regarded as an appropriate treatment solution.
  • The subject has an osseous architecture enough to receive three implants with a length of at least 11.5 mm and a diameter of 5 mm in the interforaminal (e.g. jaw volume B, C or D; inter foramina distance at least 20 mm; buccal/lingual width at least 6-7 mm, vertical height after leveling bone sufficient to receive an implant of at least 11.5 mm length).
  • The subject has a jaw curvature that fits to the prefabricated framework design.
  • Implants will be placed in healed or extraction sites (clinical stability has to be ensured).
  • The implant sites are free from infection and extraction remnants.
  • The subjects as well as the implant sites fulfill the criteria for early loading.

Smokers that have reduced their consumption may be included after a certain test phase (e.g. test phase for reduction from 2 to 1 packages of cigarettes should be at least 6 months).

Class II inter-jaw relation patients are not an exclusion criteria per se. Based on the individual judgment of the clinician those patients may be treated.

Subject inclusion criteria at time of surgery

  • After bone leveling sufficient mandible bone volume in the interforaminal present for three (3) implants with a length of at least 11.5 mm and a diameter of 5 mm.
  • After bone leveling the jaw curvature does fit to the prefabricated framework.
  • The implant sites are free from infection and extraction remnants.
  • The subject as well as the implant sites fulfill the criteria for early loading.

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 history.
  • Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous irradiation.
  • Alcohol or drug abuse as noted in subject records or in subject history.
  • Smoking of more than 1 package of cigarettes per day (> 20 cigarettes or equivalent).
  • 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%.
  • Bisphosphonate therapy - based on individual judgment of the clinician (if intravenously administered or too high oral doses recently before surgery and during follow-up period).
  • Pathologic occlusion, e.g. severe bruxism or other destructive habits.
  • Lack of opposing dentition or unstable occlusion.
  • Ongoing infections, endodontic or periodontal problems in opposing teeth or implants.
  • Subject shows an unacceptable oral hygiene.
  • Subject has allergic or adverse reactions to the restorative material.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Chile,   Italy,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02940353
Other Study ID Numbers  ICMJE T-188
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nobel Biocare
Study Sponsor  ICMJE Nobel Biocare
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nobel Biocare
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP