RCT: Effectiveness of PEEK Fixed Retainer

Sponsor

Esraa Salman Jasim (Other)

Overall Status

Recruiting

CT.gov ID

NCT05557136

Collaborator

University of Baghdad (Other)

Enrollment

Location

Arms

14.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retention	Device: Multistranded stainless steel fixed retainer Device: Polyether-Ether-Ketone (PEEK) fixed retainer	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Sep 3, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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.
Experimental: 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	Device: 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.

Arm

Intervention/Treatment

Experimental: 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

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.

Experimental: 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

Device: 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.

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years to 32 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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