A RCT to Compare OHRQoL Outcome for SLB and CB

Study Overview
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Brief Summary
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The objective of this prospective study is to compare these two treatments (conventional brackets v.s. self-ligating brackets) in malocclusion to determine which treatment will provide the better oral health related quality of life (OHRQoL) outcomes for patients during the initial orthodontic treatment compared with pretreatment.

Official Title
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A Randomized Clinical Trial to Compare Oral Health Related Quality of Life Outcome for Patients With Malocclusion Receiving Orthodontic Treatment: Before Treatment vs. During Initial Treatment; Self-ligating Brackets vs. Conventional Brackets

Conditions
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Malocclusion

Intervention / Treatment
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* Device: Self-ligating brackets (SLB)
* Device: Conventional brackets (CB)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: malocclusion patients age between 12 to 40 years suitable for orthodontic treatment using either self-ligating brackets or conventional brackets. Exclusion Criteria: Any surgery performed in the previous days, Previous temporomandibular joint arthrotomies, Fewer than 20 teeth total or fewer than 10 teeth in each arch, Unstable residence or travel restrictions, Periodontal disease judged to be severe by the surgeon, Pregnancy, Previous mandibular surgery, and Inability to follow instructions or the study protocol.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-ligating brackets<br>Several self-ligating brackets are currently FDA-approved but have not been rigorously studied in this malocclusion patient population or in comparison to traditional brackets methods. Unlike conventional brackets, Self-ligating brackets (SLB) are bracket systems, without the wire ligature or elastic ligature, that have a tube-like device build into the bracket to close off the edgewise slot. | Device: Self-ligating brackets (SLB)<br> <br> * Other names: Damon Q;|
| Placebo Comparator: Conventional brackets<br>The conventional brackets (CB) (edgewise appliance) retain the basic principle design of a rectangular wire in a rectangular slot. Archwire are tied to the bracket once placed in the slot with either elastometric ligation ties (O-rings) or steel ligation. | Device: Conventional brackets (CB)<br> <br> * Other names: OPAK;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Reported Outcome - Oral Health Related Quality of Life |  | one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral health-related quality of life (OHRQoL), Self-ligating brackets (SLB), Conventional brackets (CB), Oral Health Impact Profile-14 (OHIP-14), Short Form-36 (SF-36)