Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite
ConditionOpen Bite
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorKufa University
About this trial
The goal of this randomised clinical trial study is to investigate 3D-printed shape memory aligners in the treatment of anterior dental open bite adult patients. The main questions it aims to answer are:
1. Do 3D-direct-printed shape memory aligners demonstrate potentiality in the management of AOB? 2. What is the effect of 3D-direct printed shape memory aligners on molar intrusion? 3. Can the 3D-direct printed shape memory aligners extrude anterior teeth without the use of attachments? 4. Do 3D-direct printed shape memory aligners generate greater/higher stress distribution and initial teeth displacement compared to conventional clear aligners? Researchers will compare three groups: Group I: Patients treated with conventional clear aligners with attachments; Group II: Patients treated with 3D direct-printed shape-memory aligner without attachment; Group III: Patients treated with 3D direct-printed shape memory clear aligners with attachments and see its effect on anterior open bite treatment.
Participants will wear a clear aligner for about 6-8 months. Then
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18-35 years,
Both genders.
The patient is well fitted with no systemic disease.
Mild-moderate dental anterior open bite.
Disqualifiers
Patient with a history of trauma to the molars or incisors.
Patient with a history of endodontic treatment to the maxillary first molar or incisors.
Patient with a systemic disease related to bone metabolism.
Patient taking immunosuppressive drugs or drugs inhibiting or accelerating tooth movement; and
Trial design
Design model
Parallel
Treatments tested in this trial
SMA with attachment
Device3D direct-printed shape memory clear aligner with horizontal rectangular attachment
SMA without attachments
Device3D direct-printed shape memory clear aligner without horizontal rectangular attachment
CA with attachment
DeviceThermoformed conventional clear aligner with horizontal rectangular attachment
Treatment groups
51 Participants
are divided into 3 treatment groupsGroup A: SM AActive comparator 1 intervention
Group B: SMActive comparator 1 intervention
Group C: CAActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Patient-reported outcomes measures (PROMs)
Participants will complete a set of Patient-Reported Outcome Measures (PROMs). Initially, participants will be required to provide several pieces of information, including name, date of birth, gender, residential address, phone number, email address, and date of consultation. Subsequently, participants from all three study groups will respond to ten PROM items assessing various aspects of outcome measures: "I feel pain", "I can move more easily", "I feel strong", "I feel coordinated", "I feel tired", "I can sleep", "I can do activities of daily living", "I can return to work and sports", "I am satisfied with my care", and "I would recommend physical therapy to others". Each item will be rated using a 5-point Likert scale, with response options ranging from 1 (strongly disagree) to 5 (strongly agree). All personal and response data will be treated with strict confidentiality. This interview questioner will take before and after the treatment.
Time frame
perioperativeSponsors and contacts
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Source ClinicalTrials.gov