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Effectiveness of PEEK Fixed Retainer

The Effectiveness of Polyether-Ether-Ketone (PEEK) as a Fixed Retainer Compared to Multistranded Stainless Steel Wires: A Randomized Clinical Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05557136
Acronym
RCT
Enrollment
40
Registered
2022-09-27
Start date
2022-09-03
Completion date
2023-12-01
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retention

Keywords

Retention, Stability, Periodontal indices, Fixed retainer, PEEK

Brief summary

A randomized clinical trial is set out to compare the effectiveness of two types of fixed retainer (multistranded stainless steel and PEEK types) in maintaining the stability of lower anterior teeth with less failure rate.

Detailed description

It is a multicenter randomized clinical trial with two arms parallel group. The patients will be randomly divided into two groups, group one: multistranded stainless steel fixed retainer will be used while, and group two PEEK fixed retainer will be used. An intra-oral scan, intra-oral swap and periodontal indices will be taken before starting the treatment (T0), after one month (T1), after 3 months (T2), and after 6 months (T3). Patient perception concerning the fixed retainer will be taken for the patients.

Interventions

DEVICEMultistranded stainless steel fixed retainer

Multistranded stainless steel fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.

DEVICEPolyether-Ether-Ketone (PEEK) fixed retainer

Polyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.

Sponsors

University of Baghdad
CollaboratorOTHER
Esraa Salman Jasim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
12 Years to 32 Years
Healthy volunteers
Yes

Inclusion criteria

* Age: 17-32 years. * Patients with a score of 0-0.5 on Little's irregularity index in the lower arch. * Patients treated with the pre-adjusted orthodontic appliance (both Extraction and non-extraction cases). * Patients who have healthy periodontal condition

Exclusion criteria

* Patients treated with rapid maxillary expansion or surgically assisted rapid maxillary expansion. * Patients with a cleft lip / and or palate. * Patients with a deep overbite and traumatic parafunctional habits such as bruxism and clenching. * Patients with carious, restored, fractured, or missing lower anterior teeth. * Patients with medical health problems that may influence gingival health like uncontrolled type II diabetic patient, patients with hormonal disturbances or systemic drug administration that effect on oral health. * Smokers

Design outcomes

Primary

MeasureTime frameDescription
Stability of lower anterior teethT0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 monthThe effectiveness of PEEK retainers as compared to a dead-soft multi-stranded stainless-steel wire in maintaining alignment of the lower anterior teeth in terms of Little's irregularity index.

Secondary

MeasureTime frameDescription
Failure rateT0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 monthhow many times the retainer needed to be replaced or repaired
Periodontal health statusT0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 monthThe effect of fixed retainer on the periodontal health is measured by oral hygiene indices
Patient satisfactionAt T1 after one month and T3 after 6 monthPatient satisfaction concerning esthetics, speech and comfort is obtain by questionnaire.
BiohostabilityT0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 monthstudying the microbial colonization on the retainer wire by using oral swap of fixed retainer and measure total bacterial count (Aerobic and Facultative Anaerobic) on Blood agar, Total streptococcus count and total lactobacillus count on selective media

Countries

Iraq

Contacts

Primary ContactEsraa Jasim
israa_salman27@codental.uobaghdad.edu.iq7702999312
Backup ContactAmmar Salim
ammar.ortho@codental.uobaghdad.edu.iq7702500415

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026