Comparing two types of fixed retainers for dental stability
The Effectiveness of Polyether-Ether-Ketone (PEEK) as a Fixed Retainer Compared to Multistranded Stainless Steel Wires: A Randomized Clinical Trial
This study is testing which type of fixed retainer, either multistranded stainless steel or PEEK, works better to keep lower front teeth stable after orthodontic treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 12 Years to 32 Years |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 1 site (Baghdad, Baghdad, Bab Al-Moadham) |
| Trial ID | NCT05557136 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different types of fixed retainers, multistranded stainless steel and PEEK, in maintaining the stability of lower anterior teeth. It is a multicenter randomized trial where participants will be divided into two groups, each receiving one type of retainer. Assessments will include intra-oral scans, swabs, and periodontal indices at multiple time points: before treatment and at one, three, and six months post-treatment. Additionally, patient perceptions regarding the retainers will be collected to gauge comfort and satisfaction.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 17-32 with healthy periodontal conditions and minimal irregularity in the lower arch.
Not a fit: Patients with significant dental issues, such as deep overbite, bruxism, or systemic health problems affecting oral health, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved retention methods for patients undergoing orthodontic treatment, enhancing dental stability and patient satisfaction.
How similar studies have performed: While there have been studies on fixed retainers, the specific comparison of PEEK to stainless steel in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baghdad, Baghdad, Bab Al-Moadham
- Esraa S Jasim — Baghdad, Baghdad, Bab Al-Moadham, Iraq (Recruiting)
Study contacts
- Study coordinator: Esraa Jasim
- Email: israa_salman27@codental.uobaghdad.edu.iq
- Phone: 7702999312
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.