Effectiveness of PEEK Fixed Retainer
RCT
The Effectiveness of Polyether-Ether-Ketone (PEEK) as a Fixed Retainer Compared to Multistranded Stainless Steel Wires: A Randomized Clinical Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 2, 2022
CompletedStudy Start
First participant enrolled
September 3, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJuly 25, 2023
July 1, 2023
1.1 years
September 2, 2022
July 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Stability of lower anterior teeth
The 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.
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Secondary Outcomes (4)
Failure rate
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Periodontal health status
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Patient satisfaction
At T1 after one month and T3 after 6 month
Biohostability
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Study Arms (2)
Multistranded stainless steel fixed retainer
EXPERIMENTALMultistranded stainless steel fixed retainer is used for lower anterior teeth (canine to canine) to maintain the stability of teeth after completion of orthodontic treatment
Polyether-Ether-Ketone (PEEK) fixed retainer
EXPERIMENTALPolyether-Ether-Ketone (PEEK) fixed retainer is used for lower anterior teeth (canine to canine) to maintain the stability of teeth after completion of orthodontic treatment
Interventions
Multistranded stainless steel fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.
Polyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Esraa Salman Jasimlead
- University of Baghdadcollaborator
Study Sites (1)
Esraa S Jasim
Baghdad, Baghdad, Bab Al-Moadham, 10047, Iraq
Related Publications (2)
Jasim ES, Kadhum AS. Poly-Ether-Ether-Ketone versus dead-soft coaxial bonded retainers: a randomized clinical trial. Part 2: periodontal health and microbial biofilm assessment. Eur J Orthod. 2024 Oct 1;46(5):cjae048. doi: 10.1093/ejo/cjae048.
PMID: 39312715DERIVEDJasim ES, Kadhum AS. Poly-ether-ether-ketone (PEEK) versus dead-soft coaxial bonded retainers: a randomized clinical trial. Part 1. Stability, retainer failure, and participant satisfaction. Eur J Orthod. 2024 Oct 1;46(5):cjae044. doi: 10.1093/ejo/cjae044.
PMID: 39206494DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ammar S Kadhum
University of Baghdad
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assist.Prof.
Study Record Dates
First Submitted
September 2, 2022
First Posted
September 27, 2022
Study Start
September 3, 2022
Primary Completion
October 1, 2023
Study Completion
December 1, 2023
Last Updated
July 25, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share