MalocclusionNCT06478771
The Effect of Patient Preference on Retention Success
A study testing Essix retainer and Lingual retainer in people with Malocclusion and Orthodontic Retention, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malocclusion, Orthodontic Retention
- What is being tested?
- Essix retainer and Lingual retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Dec 2021to 12 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients older than age 12
- Patients who have been treated with fixed orthodontic appliances
- Patients with good standard of oral hygiene
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does the Patient Choice of Retainer Affect Retention Success?: A Randomized Controlled Study
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
Read the 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
- Being tested
- Essix retainer, Lingual retainer
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essix retainerDevice
A clear plastic removable retainer.
Lingual retainerDevice
A fixed retainer placed on the lingual side of the teeth.
| Study group | Role | What they receive |
|---|---|---|
| Patient choice-essix retainer | Experimental | The group in which the patient chooses the retention appliance, essix retainer Receives: Device: Essix retainer |
| Patient choice-lingual retainer | Experimental | The group in which the patient chooses the retention appliance, lingual retainer Receives: Device: Lingual retainer |
| Clinician choice-essix retainer | Active comparator | The group from which the orthodontist chooses the retention appliance, essix retainer Receives: Device: Essix retainer |
| Clinician choice-lingual retainer | Active comparator | The group from which the orthodontist chooses the retention appliance, lingual retainer Receives: Device: Lingual retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (3)
Retainer survival
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."
Measured: 2 years
Oral health
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.
Measured: 2 years
Patient satisfaction
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start14 Dec 2021
- Primary completion14 Mar 2024
- Study completion12 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Irmak Ocak, Hacettepe University
- Investigators
- Irmak Ocak, Study director, Hacettepe University, Faculty of Dentistry, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478771
- Sponsor's protocol ID
- 24237859-144
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, we do not plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Patient Choice of Retainer Affect Retention Success?: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06478771
- Acronym / sponsor ID
- 24237859-144
- Conditions
- Malocclusion, Orthodontic Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 14 Mar 2024 (actual)
- Study completion
- 12 Jun 2024 (actual)
- First posted
- 27 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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)
| Arm | Type | Receives |
|---|---|---|
| Patient choice-essix retainer | Experimental | Device: Essix retainerThe group in which the patient chooses the retention appliance, essix retainer |
| Patient choice-lingual retainer | Experimental | Device: Lingual retainerThe group in which the patient chooses the retention appliance, lingual retainer |
| Clinician choice-essix retainer | Active comparator | Device: Essix retainerThe group from which the orthodontist chooses the retention appliance, essix retainer |
| Clinician choice-lingual retainer | Active comparator | Device: Lingual retainerThe group from which the orthodontist chooses the retention appliance, lingual retainer |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients older than age 12
- Patients who have been treated with fixed orthodontic appliances
- Patients with good standard of oral hygiene
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essix retainerA clear plastic removable retainer. | Device | Clinician choice-essix retainer, Patient choice-essix retainer |
| Lingual retainerA fixed retainer placed on the lingual side of the teeth. | Device | Clinician choice-lingual retainer, Patient choice-lingual retainer |
Primary outcome
Stability
Time frame: 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.
3 secondary outcomes
Retainer survival
Time frame: 2 years
Oral health
Time frame: 2 years
Patient satisfaction
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Individual participant dataSharing planned: No. No, we do not plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irmak Ocak study director
Hacettepe University, Faculty of Dentistry, Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essix retainer and Lingual retainer in people with Malocclusion and Orthodontic Retention, run by Hacettepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024.