Effectiveness of PEEK Fixed Retainer

Retention Clinical Trial

— RCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05557136
• Other study ID #: 621422
• Status: Recruiting
• Phase: N/A
• Start date: September 3, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: July 2023
• Source: University of Baghdad
• Contact: Esraa Jasim
• Phone: 7702999312
• Email: israa_salman27[@]codental.uobaghdad.edu.iq
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 32 Years

Eligibility

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

Related Conditions & MeSH terms

• Retention

Intervention

Device:
• Multistranded stainless steel fixed retainer
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
Polyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.

Locations

Country	Name	City	State
Iraq	Esraa S Jasim	Baghdad	Baghdad, Bab Al-Moadham

Sponsors (2)

Lead Sponsor	Collaborator
Esraa Salman Jasim	University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Patient satisfaction	Patient satisfaction concerning esthetics, speech and comfort is obtain by questionnaire.	At T1 after one month and T3 after 6 month
Secondary	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