Clinical trial NCT06478771: The Effect of Patient Preference on Retention Success
Official title: Does the Patient Choice of Retainer Affect Retention Success?: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion
Orthodontic Retention
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 128
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stability
timeFrame: 2 years
Secondary outcomes:
measure: Retainer survival
timeFrame: 2 years
measure: Oral health
timeFrame: 2 years
measure: Patient satisfaction
timeFrame: 2 years
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Irmak Ocak
Study officials:
affiliation: Hacettepe University, Faculty of Dentistry, Department of Orthodontics
name: Irmak Ocak
role: STUDY_DIRECTOR
References: