RetentionRCTNCT05557136
Effectiveness of PEEK Fixed Retainer
A study testing Multistranded stainless steel fixed retainer and Polyether-Ether-Ketone (PEEK) fixed retainer in people with Retention, run by Esraa Salman Jasim at 1 site in Iraq.
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. Read more about this study
- Who is it for?
- Ages 12 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Retention
- What is being tested?
- Multistranded stainless steel fixed retainer and Polyether-Ether-Ketone (PEEK) fixed retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 3 Sep 2022to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 32 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
Esraa S Jasim
Baghdad, Baghdad, Bab Al-Moadham, 10047
Ammar S Kadhum, Assist.Prof
Esraa S Jasim, Assist.Prof
About this study
Official title: 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.
Read the 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.
- Conditions
- Retention
- Being tested
- Multistranded stainless steel fixed retainer, Polyether-Ether-Ketone (PEEK) fixed retainer
- Keywords
- Retention, Stability, Periodontal indices, Fixed retainer, PEEK
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multistranded stainless steel fixed retainerDevice
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 retainerDevice
Polyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment.
| Study group | Role | What they receive |
|---|---|---|
| Multistranded stainless steel fixed retainer | Experimental | 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 Receives: Device: Multistranded stainless steel fixed retainer |
| Polyether-Ether-Ketone (PEEK) fixed retainer | Experimental | 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 Receives: Device: Polyether-Ether-Ketone (PEEK) fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Secondary outcomes (4)
Failure rate
how many times the retainer needed to be replaced or repaired
Measured: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Periodontal health status
The effect of fixed retainer on the periodontal health is measured by oral hygiene indices
Measured: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Patient satisfaction
Patient satisfaction concerning esthetics, speech and comfort is obtain by questionnaire.
Measured: At T1 after one month and T3 after 6 month
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
Measured: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start3 Sep 2022
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for RetentionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Esraa Salman Jasim
- Sponsor type
- University, hospital or other
- Collaborators
- University of Baghdad
- Responsible party
- Sponsor-investigator, Esraa Salman Jasim, University of Baghdad
- Investigators
- Ammar S Kadhum, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05557136
- Sponsor's protocol ID
- 621422
- Acronym
- RCT
- Status last verified
- Jul 2023
- First submitted
- 2 Sep 2022
- Last updated
- 25 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39312715Jasim 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.
PubMed 39206494
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Polyether-Ether-Ketone (PEEK) as a Fixed Retainer Compared to Multistranded Stainless Steel Wires: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05557136
- Acronym / sponsor ID
- RCT / 621422
- Conditions
- Retention
- Keywords
- Retention, Stability, Periodontal indices, Fixed retainer, PEEK
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Esraa Salman JasimUniversity, hospital or other
- Collaborators
- University of Baghdad
- Study start
- 3 Sep 2022 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multistranded stainless steel fixed retainer | Experimental | Device: Multistranded stainless steel fixed retainerMultistranded 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 | Experimental | Device: Polyether-Ether-Ketone (PEEK) fixed retainerPolyether-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 |
Who may qualify
- Ages
- 12 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multistranded stainless steel fixed retainerMultistranded stainless steel fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment. | Device | Multistranded stainless steel fixed retainer |
| Polyether-Ether-Ketone (PEEK) fixed retainerPolyether-Ether-Ketone (PEEK) fixed retainer is used for orthodontic patient after completion of orthodontic treatment to achieve stability of alignment. | Device | Polyether-Ether-Ketone (PEEK) fixed retainer |
Primary outcome
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.
4 secondary outcomes
Failure rate
Time frame: 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
Patient satisfaction
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Derived from this study: PubMed 39312715Jasim 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.
- Derived from this study: PubMed 39206494Jasim 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.
- Individual participant dataSharing planned: No
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Healthy Volunteer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ammar S Kadhum study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multistranded stainless steel fixed retainer and Polyether-Ether-Ketone (PEEK) fixed retainer in people with Retention, run by Esraa Salman Jasim at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esraa Jasim (7702999312 ext. 00964, israa_salman27@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05557136, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.