Effectiveness of PEEK Fixed Retainer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retention

Intervention / Treatment
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* Device: Multistranded stainless steel fixed retainer
* Device: Polyether-Ether-Ketone (PEEK) fixed retainer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 32 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multistranded stainless steel fixed retainer<br>Multistranded stainless steel fixed retainer is used for lower anterior teeth (canine to canine) to maintain the stability of teeth after completion of orthodontic treatment | Device: Multistranded stainless steel fixed retainer<br>* Multistranded stainless steel fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.<br>|
| Experimental: Polyether-Ether-Ketone (PEEK) fixed retainer<br>Polyether-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 | Device: Polyether-Ether-Ketone (PEEK) fixed retainer<br>* Polyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure rate | how many times the retainer needed to be replaced or repaired | T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month | 
| Periodontal health status | The effect of fixed retainer on the periodontal health is measured by oral hygiene indices | T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month | 
| Patient satisfaction | Patient satisfaction concerning esthetics, speech and comfort is obtain by questionnaire. | At T1 after one month and T3 after 6 month | 
| Biohostability | studying 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 | T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Retention, Stability, Periodontal indices, Fixed retainer, PEEK