Clinical trial NCT05557136: Effectiveness of PEEK Fixed Retainer
Official title: The Effectiveness of Polyether-Ether-Ketone (PEEK) as a Fixed Retainer Compared to Multistranded Stainless Steel Wires: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Retention
Keywords: Retention
Stability
Periodontal indices
Fixed retainer
PEEK
Lead sponsor: University of Baghdad
Sponsor class: OTHER
Collaborators: name: University of Baghdad
First posted: 2022-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 32
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stability of lower anterior teeth
timeFrame: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Secondary outcomes:
measure: Failure rate
timeFrame: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
measure: Periodontal health status
timeFrame: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
measure: Patient satisfaction
timeFrame: At T1 after one month and T3 after 6 month
measure: Biohostability
timeFrame: T0 is the stating of retention, T1 after one month, T2 after 3 months and T3 after 6 month
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Esraa S Jasim
state: Baghdad, Bab Al-Moadham
Study officials:
affiliation: University of Baghdad
name: Ammar S Kadhum
role: STUDY_DIRECTOR
References: