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Trial registered on ANZCTR


Registration number
ACTRN12622001255774p
Ethics application status
Submitted, not yet approved
Date submitted
15/09/2022
Date registered
19/09/2022
Date last updated
19/09/2022
Date data sharing statement initially provided
19/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the effectiveness of using Poly Ether Ketone (PEK) framework to reinforce digital dental prostheses to prevent prostheses fracture for edentulous adult requiring dental rehabilitation
Scientific title
Efficacy of Poly Ether Ketone (PEK) framework to reinforce digital dental prostheses to prevent prostheses fracture for edentulous adult requiring dental rehabilitation
Secondary ID [1] 307968 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edentulous 327630 0
Condition category
Condition code
Oral and Gastrointestinal 324718 324718 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
The use of Poly Ether Ketone (PEK) framework reinforced digital dental prostheses will be offered to participants who are partially or completely edentulous requiring dental rehabilitation in place of other standard of care dental protheses such as a traditionally hand crafted dental prothesis or digital dental prothesis.

PEK framework reinforced digital dental prostheses will be manufactured to match participant’s dentition using computer aided design and computer aided manufacturing.

Participants will be asked to participate in the following interventions:
Intervention
• Appointment 1 (4 weeks prior to Baseline visit and Approximately 1 hour duration):
o Obtain intraoral scan or impression/mould of the teeth and soft tissues
o Administration of dental rehabilitation satisfaction quality of life questionnaire
• Appointment 2 (Baseline and Approximately 1 hour duration): Placement of PEK reinforced digital dental prosthesis

Participants will wear the prosthesis all day and night for 12 months.

Follow up
• 3 months (Approximately 1 hour duration):
o Assessment of the dental prosthesis for any sign of fracture
o Administration of dental rehabilitation satisfaction quality of life questionnaire

• 6 months (Approximately 1 hour duration):
o Assessment of the dental prosthesis for any sign of fracture
o Administration of dental rehabilitation satisfaction quality of life questionnaire

• 12 months (Approximately 1 hour duration):
o Assessment of the dental prosthesis for any sign of fracture
o Administration of dental rehabilitation satisfaction quality of life questionnaire

Intervention will be delivered face to face in the hospital clinic by a qualified reconstructive surgeon/oral and maxillofacial surgeon/prosthodontist.

There is no requirement for assessment of adherence. The design of PEK reinforced digital dental prosthesis will conducted under a specific protocol to maintain the fidelity of intervention.
Intervention code [1] 324428 0
Treatment: Devices
Comparator / control treatment
Historical control group (Source: Medical Record from Chris O'Brien Lifehouse Hospital, Time Period: 5 years from July 2017 to June 2022)
Control group
Historical

Outcomes
Primary outcome [1] 332551 0
To assess the rate of fracture using a PEK framework reinforced digital dental prosthesis compared to historical controls by clinical examination by reconstructive surgeon/oral and maxillofacial surgeon/prosthodontist.
Timepoint [1] 332551 0
At baseline, 3 months follow up, 6 months follow up, and 12 months follow up.
Secondary outcome [1] 413881 0
Change in patient quality of life measured by dental rehabilitation satisfaction questionnaire.
Timepoint [1] 413881 0
Baseline, 3 months follow up, 6 months follow up, and 12 months follow up

Eligibility
Key inclusion criteria
• 18 years and older
• Partial or complete edentulous requiring dental rehabilitation
• Willingness to give informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients where placement of a dental prosthesis is contraindicated due to medical/surgical parameters, guided by their managing physician.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Efficacy
Statistical methods / analysis
All data will be examined for normality. Categorical data will be presented as frequencies and percentages, and Chi Squared tests will be used to compare categorical data. QoL data will be ordinal continuous data and will be examined for normality. For data that is non-parametrically distributed the Spearman’s rho test will be used to test correlations for continuous data. For data that is parametrically distributed, the Pearson’s correlation coefficient (r) will be used to test correlations for continuous data. If conducted, post-hoc tests will be performed using the Bonferroni method to correct for multiple testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/11/2022
Actual
Date of last participant enrolment
Anticipated
28/11/2026
Actual
Date of last data collection
Anticipated
28/11/2027
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 23165 0
Chris O’Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 38528 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 312237 0
Hospital
Name [1] 312237 0
Chris O'Brien Lifehouse
Country [1] 312237 0
Australia
Primary sponsor type
Hospital
Name
Chris O'Brien Lifehouse
Address
119-143 Missenden Road Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 313772 0
None
Name [1] 313772 0
N/A
Address [1] 313772 0
N/A
Country [1] 313772 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311614 0
St Vincent’s Hospital HREC
Ethics committee address [1] 311614 0
Ethics committee country [1] 311614 0
Australia
Date submitted for ethics approval [1] 311614 0
15/09/2022
Approval date [1] 311614 0
Ethics approval number [1] 311614 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121722 0
Prof Jonathan Clark
Address 121722 0
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Country 121722 0
Australia
Phone 121722 0
+61 02 8514 0268
Fax 121722 0
Email 121722 0
Jonathan.Clark@lh.org.au
Contact person for public queries
Name 121723 0
Masako Dunn
Address 121723 0
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Country 121723 0
Australia
Phone 121723 0
+61 02 8514 0411
Fax 121723 0
Email 121723 0
Masako.Dunn@lh.org.au
Contact person for scientific queries
Name 121724 0
Jonathan Clark
Address 121724 0
Chris O'Brien Lifehouse 119-143 Missenden Road Camperdown NSW 2050
Country 121724 0
Australia
Phone 121724 0
+61 02 8514 0268
Fax 121724 0
Email 121724 0
Jonathan.Clark@lh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.