The Effect of Patient Preference on Retention Success

NCT ID: NCT06478771

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-14
• Study Completion Date: 2024-06-12

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.

Conditions

Malocclusion; Orthodontic Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Patient choice-essix retainer

The group in which the patient chooses the retention appliance, essix retainer

Group Type: EXPERIMENTAL

Essix retainer

Intervention Type: DEVICE

A clear plastic removable retainer.

Patient choice-lingual retainer

The group in which the patient chooses the retention appliance, lingual retainer

Group Type: EXPERIMENTAL

Lingual retainer

Intervention Type: DEVICE

A fixed retainer placed on the lingual side of the teeth.

Clinician choice-essix retainer

The group from which the orthodontist chooses the retention appliance, essix retainer

Group Type: ACTIVE_COMPARATOR

Essix retainer

Intervention Type: DEVICE

A clear plastic removable retainer.

Clinician choice-lingual retainer

The group from which the orthodontist chooses the retention appliance, lingual retainer

Group Type: ACTIVE_COMPARATOR

Lingual retainer

Intervention Type: DEVICE

A fixed retainer placed on the lingual side of the teeth.

Interventions

Essix retainer

A clear plastic removable retainer.

Intervention Type: DEVICE

Lingual retainer

A fixed retainer placed on the lingual side of the teeth.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hacettepe University

OTHER

Sponsor Role: lead

Responsible Party

Irmak Ocak

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Irmak Ocak

Role: STUDY_DIRECTOR

Hacettepe University, Faculty of Dentistry, Department of Orthodontics

Locations

Irmak Ocak

Ankara, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

24237859-144

Identifier Type: -

Identifier Source: org_study_id