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The TREFOIL Concept 5 Year Clinical Investigation

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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

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).

Condition or disease Intervention/treatment Phase
Edentulous or Failing Dentition Mandible Device: TREFOIL concept Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The TREFOIL Concept: A Clinical Investigation in the Mandible on 3 Implants With a Fixed Prefabricated Framework
Study Start Date : April 2016
Estimated Primary Completion Date : April 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Treatment with Trefoil concept
Treatment
Device: TREFOIL concept



Primary Outcome Measures :
  1. Cumulative survival rates for the implants [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02940353


Locations
United States, Washington
Dr. Higuchi &Skinner
Spokane, Washington, United States, 99216-1077
Australia, Western Australia
Branemark Centre
Perth, Western Australia, Australia, 6005
Austria
Bernhard-Gottlieb-Universitätsklinik
Vienna, Austria, 1090
Chile
Clinica Rosenberg
Santiago, Santiago De Chile, Chile, 10373
Italy
University of Verona
Verona, Italy, 37131
Spain
Instituto Davó, Hospital Medimar Internacional
Alicante, Spain, 03016
Sponsors and Collaborators
Nobel Biocare

Responsible Party: Nobel Biocare
ClinicalTrials.gov Identifier: NCT02940353     History of Changes
Other Study ID Numbers: T-188
First Posted: October 20, 2016    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: May 2018