Effectiveness of PEEK Fixed Retainer
- Conditions
- Retention
- Interventions
- Device: Multistranded stainless steel fixed retainerDevice: Polyether-Ether-Ketone (PEEK) fixed retainer
- Registration Number
- NCT05557136
- Lead Sponsor
- Esraa Salman Jasim
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multistranded stainless steel fixed retainer Multistranded stainless steel fixed retainer 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 Polyether-Ether-Ketone (PEEK) fixed retainer Polyether-Ether-Ketone (PEEK) fixed retainer 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
- Primary Outcome Measures
Name Time Method Stability of lower anterior teeth T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month 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.
- Secondary Outcome Measures
Name Time Method Periodontal health status T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month The effect of fixed retainer on the periodontal health is measured by oral hygiene indices
Patient satisfaction At T1 after one month and T3 after 6 month Patient satisfaction concerning esthetics, speech and comfort is obtain by questionnaire.
Biohostability T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month 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
Failure rate T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month how many times the retainer needed to be replaced or repaired
Trial Locations
- Locations (1)
Esraa S Jasim
🇮🇶Baghdad, Baghdad, Bab Al-Moadham, Iraq