The TREFOIL Concept 5 Year Clinical Investigation

• ClinicalTrials.gov Identifier: NCT02940353
• Recruitment Status: Completed
• First Posted: October 20, 2016
• Last Update Posted: March 22, 2023
• Sponsor: Nobel Biocare
• Information provided by (Responsible Party): Nobel Biocare

Tracking Information

• First Submitted Date: October 19, 2016
• First Posted Date: October 20, 2016
• Last Update Posted Date: March 22, 2023
• Study Start Date: April 2016
• Actual Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: October 20, 2016): Cumulative survival rates for the implants [ Time Frame: 5 years ]
• Original Primary Outcome Measures (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 ]
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The TREFOIL Concept 5 Year Clinical Investigation
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Edentulous or Failing Dentition Mandible
• Intervention: Device: TREFOIL concept

Study Arms

Treatment with Trefoil concept

Treatment

Intervention: Device: TREFOIL concept

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2018): 110
• Original Estimated Enrollment (submitted: October 19, 2016): 90
• Actual Study Completion Date: June 2022
• Actual Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Australia, Chile, Italy, Spain, United States
• Removed Location Countries: Austria

Administrative Information

• NCT Number: NCT02940353
• Other Study ID Numbers: T-188
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Nobel Biocare
• Original Responsible Party: Same as current
• Current Study Sponsor: Nobel Biocare
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Nobel Biocare
• Verification Date: September 2022