Malocclusion, Orthodontic Retention
Conditions
Brief summary
Aim of the Study: To determine whether allowing the patient to choose the type of retainer affects the success of retention in terms of stability and patient satisfaction. Hypothesis: Allowing the patient to choose their retainer can increase the success of retention. Design: Two-arm parallel group randomized controlled clinical trial
Detailed description
This study investigates whether allowing patients to choose the type of retainer-fixed or removable-affects the success of orthodontic retention in terms of stability and patient satisfaction. The hypothesis is that patient autonomy in selecting their retainer type can enhance retention success. Conducted as a two-arm parallel group randomized controlled trial, the study involves patients who have completed fixed appliance treatment. Participants are randomly assigned to either the intervention group, where they choose their retainer type after being informed of the pros and cons, or the control group, where the clinician decides the retainer type. The primary outcome of the study is the stability of the orthodontic treatment, with secondary outcomes including retainer survival, oral health, and patient satisfaction. Stability is measured using indices such as Little's irregularity index, inter-canine width, and overjet, among others. Oral health is evaluated based on caries presence, sulcus depth, and gingival bleeding. Retainer survival is monitored by incidents of losing or breaking the retainer. Patient satisfaction is assessed through a detailed questionnaire covering aspects such as retainer usage, comfort, and perceived value. Due to the nature of the intervention, blinding is not possible for operators, participants, or assessors. This study aims to provide insights into how patient choice influences the outcomes of orthodontic retention, potentially guiding future clinical practices towards enhanced patient satisfaction and treatment success. This study aims to provide valuable insights into the impact of patient autonomy on orthodontic retention outcomes. By comparing patient-chosen and clinician-chosen retainer types, the research seeks to enhance our understanding of factors contributing to successful orthodontic retention and overall patient satisfaction.
Interventions
DEVICEEssix retainer
A clear plastic removable retainer.
DEVICELingual retainer
A fixed retainer placed on the lingual side of the teeth.
Sponsors
Hacettepe University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Masking description
In this study, masking (blinding) is not possible due to the nature of the intervention. Both the participants and care providers, as well as the outcome assessors, will be aware of the type of retainer being used.
Intervention model description
Study group: Patients choose the type of retainer (Subgroup: fixed or removable) Control group: The clinician selects the retainer type (Subgroup: fixed or removable)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Patients older than age 12 2. Patients who have been treated with fixed orthodontic appliances 3. Patients with good standard of oral hygiene
Exclusion criteria
1. Patients with initial diastema or other significant spacing 2. Patients with dentofacial syndromes/cleft lip and palate 3. Patients who had orthodontic treatment before 4. Patients with hypodontia (more than one tooth missing, except third molars) 5. Patients who have undergone orthognathic surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stability | 2 years | Stability will be assessed using Little's Irregularity Index at baseline and 24 months post-treatment. The index measures the alignment of anterior teeth, with scores ranging from 0 (perfect alignment) to 10 (severe misalignment). Lower scores indicate better outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retainer survival | 2 years | The survival rate of retainers will be monitored over a 24-month period. This includes the number of participants who retain their original retainer without breakage or loss. Retainer survival will be categorized into retained, broken, and lost. |
| Oral health | 2 years | Oral health will be assessed at baseline and 24 months post-treatment using clinical examinations for caries presence (will be evaluated by inspection, will be stated as a number), gingival bleeding (measured by the Gingival Bleeding Index), and sulcus depth (measured in millimeters using a periodontal probe). Lower scores for gingival bleeding and sulcus depth indicate better oral health. |
| Patient satisfaction | 2 years | Patient satisfaction will be measured using a questionnaire. 8 questions in the questionnaire are yes or no questions. Other 3 questions are 5-point Likert questions. |
Countries
Turkey (Türkiye)
Outcome results
None listed