None listed
Conditions
Brief summary
The use of computer aided design and computer aided manufacturing dental prosthodontics have reduced the need for skilled manual work and removed the need for multiple fittings of the prostheses. The use of a framework made of milled material called polyetheretherketone (PEEK) is a common method of reinforcement to increase the strength of the dental bridge/prosthesis and reduce fracture incidence. Polyaryletherketone (PAEK) materials are semi-crystalline aromatic polyetherketones with excellent mechanical properties. Polyetherketone (PEK) and PEEK belong to the group of PAEK, and was developed for the use in 3D printing. Considerable scientific evidence currently exists to support the biocompatibility of PEEK and PEEK has been applied extensively in dental prostheses and a variety of surgical fields. In this study, we investigate the efficacy of using a novel 3D printed PEK substructure to reinforce the standard 3D printed resin bridge/dental prosthesis to minimise the risk of prosthetic fracture.
Interventions
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.
Partici
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.
Sponsors
Chris O'Brien Lifehouse
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• 18 years and older • Partial or complete edentulous requiring dental rehabilitation • Willingness to give informed consent
Exclusion criteria
Patients where placement of a dental prosthesis is contraindicated due to medical/surgical parameters, guided by their managing physician.
Outcome results
None listed