The aim of this study is to assess the clinical suitability of PEEK bonded retainers and to evaluate its successes and failures compared to the current clinical *golden standard* multibraided stainless steel bonded retainer wires.Null Hypothesis:…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
recent behandelde tandstandafwijking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Bond failures
Pattern of failures
Secondary outcome
Possibly quantify the extent of undesired tooth movement, relying on intraoral
scans and, if necessary, intraoral photographs.
Background summary
Retention is a necessity for the stability of any orthodontic treatment
outcome. The currently used materials contain risks such as inadvertent
activity of stainless-steel bonded retainers, debonding and wire breakage. As
the quest for better materials continues, PEEK is emerging as an upcoming
candidate worth exploring.
Are the promising results of in vitro studies on PEEK bonded retainer wires
translatable to the clinic?
Study objective
The aim of this study is to assess the clinical suitability of PEEK bonded
retainers and to evaluate its successes and failures compared to the current
clinical *golden standard* multibraided stainless steel bonded retainer wires.
Null Hypothesis: The short-term failure rate of Multibraided Stainless Steel is
better than the short-term failure rate of Poly Ether Ether Ketone (PEEK) in
bonded orthodontic retention by the non-inferiorty limit (delta) of 7%.
Study design
A Randomized Multicenter Controlled Trial where the current *gold standard*
multibraided stainless steel as a fixed orthodontic retainer is clinically
compared to fixed retainers fabricated out of milled Poly-Ether-Ether-Ketone
(PEEK).
Intervention
One group will receive fixed orthodontic retention fabricated out of milled
Poly-Ether-Ehter-Ketone (PEEK) and the other group will receive fixed
orthodontic retention fabricated out of multibraided stainless steel.
Study burden and risks
A risk is that the study could conclude that Poly-Ether-Ether-Ketone (PEEK) is
performing insufficiently as fixed orthodontic retention, whereafter the fixed
retention could be replaced. Patients are seen frequently after removing
orthodontic fixed appliances so there is no suspected affect on tooth movement.
The load for the patient shall be completely comparable to the current
protocols, it can be seen as negligible.
Risks concerning the failure of fixed orthodontic retention will stay
comparable to the current existing risks using the "golden standard".
Philips van Leydenlaan 25
Nijmegen 6525 EX
NL
Philips van Leydenlaan 25
Nijmegen 6525 EX
NL
Listed location countries
Age
Inclusion criteria
Subjects with varying pre-treatment PAR-scores who agreed to participate in the
follow-up retention protocol
Exclusion criteria
- Congenital anomalies (such as cleft lip and/or palate)
- Missing lower front elements
- Congenital enamel anomalies (such as Amelogenesis and Dentinogenesis
imperfecta)
- Pre-existing Periodontal conditions (pockets of more than 3 mm)
- Patients who refuse to participate in the study
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL85417.091.24 |