Trial Review

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02940353




Registration number
NCT02940353
Ethics application status
Date submitted
19/10/2016
Date registered
20/10/2016
Date last updated
22/03/2023

Titles & IDs
Public title
The TREFOIL Concept 5 Year Clinical Investigation
Scientific title
The TREFOIL Concept: A Clinical Investigation in the Mandible on 3 Implants With a Fixed Prefabricated Framework
Secondary ID [1] 0 0
T-188
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edentulous or Failing Dentition Mandible 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - TREFOIL concept

Other: Treatment with Trefoil concept - Treatment


Treatment: Devices: TREFOIL concept
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cumulative survival rates for the implants
Timepoint [1] 0 0
5 years

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2022
Sample size
Target
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Branemark Centre - Perth
Recruitment postcode(s) [1] 0 0
6005 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Washington
Country [2] 0 0
Chile
State/province [2] 0 0
Santiago De Chile
Country [3] 0 0
Italy
State/province [3] 0 0
Verona
Country [4] 0 0
Spain
State/province [4] 0 0
Alicante

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Nobel Biocare
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02940353
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02940353