The Effect of Patient Preference on Retention Success

NCT06478771 | Completed

• 1 other identifier: 24237859-144
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Conditions

Malocclusion; Orthodontic Retention

Outcome Measures

Primary Outcomes (1)

• Stability

  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.

  2 years

Secondary Outcomes (3)

• Retainer survival

  2 years

• Oral health

  2 years

• Patient satisfaction

  2 years

Study Arms (4)

Patient choice-essix retainer

EXPERIMENTAL

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

Device: Essix retainer

Patient choice-lingual retainer

EXPERIMENTAL

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

Device: Lingual retainer

Clinician choice-essix retainer

ACTIVE COMPARATOR

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

Device: Essix retainer

Clinician choice-lingual retainer

ACTIVE COMPARATOR

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

Device: Lingual retainer

Interventions

Essix retainer DEVICE

A clear plastic removable retainer.

Clinician choice-essix retainer; Patient choice-essix retainer

Lingual retainer DEVICE

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

Clinician choice-lingual retainer; Patient choice-lingual retainer

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients older than age 12
• Patients who have been treated with fixed orthodontic appliances
• Patients with good standard of oral hygiene

You may not qualify if:

• Patients with initial diastema or other significant spacing
• Patients with dentofacial syndromes/cleft lip and palate
• Patients who had orthodontic treatment before
• Patients with hypodontia (more than one tooth missing, except third molars)
• Patients who have undergone orthognathic surgery

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Irmak Ocak

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Irmak Ocak

  Hacettepe University, Faculty of Dentistry, Department of Orthodontics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: Study group: Patients choose the type of retainer (Subgroup: fixed or removable) Control group: The clinician selects the retainer type (Subgroup: fixed or removable)

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 27, 2024
• Study Start: December 14, 2021
• Primary Completion: March 14, 2024
• Study Completion: June 12, 2024
• Last Updated: June 27, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)