Effectiveness of PEEK Fixed Retainer (RCT)

July 22, 2023 updated by: Esraa Salman Jasim

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Iraq
    • Baghdad, Bab Al-Moadham
      • Baghdad, Baghdad, Bab Al-Moadham, Iraq, 10047
        • Recruiting
        • Esraa S Jasim
        • Principal Investigator:
          • Ammar S Kadhum, Assist.Prof
        • Sub-Investigator:
          • Esraa S Jasim, Assist.Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 32 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability of lower anterior teeth
Time Frame: 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.
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
Time Frame: 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
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Periodontal health status
Time Frame: 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
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Patient satisfaction
Time Frame: At T1 after one month and T3 after 6 month
Patient satisfaction concerning esthetics, speech and comfort is obtain by questionnaire.
At T1 after one month and T3 after 6 month
Biohostability
Time Frame: 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
T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Esraa Salman Jasim

Collaborators

University of Baghdad

Investigators

  • Study Director: Ammar S Kadhum, University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2022

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

December 1, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 22, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 621422

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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