Effectiveness of PEEK Fixed Retainer

NCT ID: NCT05557136

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-03

Study Completion Date

2023-12-01

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.

Conditions

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Retention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Multistranded stainless steel fixed retainer

Intervention Type DEVICE

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 lower anterior teeth (canine to canine) to maintain the stability of teeth after completion of orthodontic treatment

Group Type EXPERIMENTAL

Polyether-Ether-Ketone (PEEK) fixed retainer

Intervention Type DEVICE

Polyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

32 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Baghdad

OTHER

Sponsor Role collaborator

Esraa Salman Jasim

OTHER

Sponsor Role lead

Responsible Party

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Esraa Salman Jasim

Assist.Prof.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ammar S Kadhum

Role: STUDY_DIRECTOR

University of Baghdad

Locations

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Esraa S Jasim

Baghdad, Baghdad, Bab Al-Moadham, Iraq

Site Status RECRUITING

Countries

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Iraq

Central Contacts

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Esraa Jasim

Role: CONTACT

7702999312 ext. 00964

Ammar Salim

Role: CONTACT

7702500415 ext. 00964

References

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Jasim ES, Kadhum AS. Poly-Ether-Ether-Ketone versus dead-soft coaxial bonded retainers: a randomized clinical trial. Part 2: periodontal health and microbial biofilm assessment. Eur J Orthod. 2024 Oct 1;46(5):cjae048. doi: 10.1093/ejo/cjae048.

Reference Type DERIVED
PMID: 39312715 (View on PubMed)

Jasim ES, Kadhum AS. Poly-ether-ether-ketone (PEEK) versus dead-soft coaxial bonded retainers: a randomized clinical trial. Part 1. Stability, retainer failure, and participant satisfaction. Eur J Orthod. 2024 Oct 1;46(5):cjae044. doi: 10.1093/ejo/cjae044.

Reference Type DERIVED
PMID: 39206494 (View on PubMed)

Other Identifiers

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621422

Identifier Type: -

Identifier Source: org_study_id

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