Clear Aligner Therapy, Malocclusions
Conditions
Keywords
Clear aligner therapy, Clear Aligner Seater
Brief summary
The goal of clinical trial is to know the role clear aligner seater. The main question it aims to answer is to evaluate the use of clear aligner seater on the effectiveness of clear aligner therapy by questioning the predictability of proposed treatment plan. * Group A (Regular-use group): Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds. * Group B (customized-use group): In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases.
Detailed description
A single-operator, multi-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted among patients seeking orthodontic treatment with clear aligner therapy. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Eligible participants will be randomly assigned to one of two aligner seater (chewy) use protocols. To minimize inter-operator variability, all participants will be treated by the same orthodontist. A standardized clinical protocol will be followed. Each participant will undergo extraoral and intraoral photography, intraoral scanning using the Medit i700 scanner (Medit Corp., Seoul, South Korea), and radiographic assessment including cone-beam computed tomography (CBCT) and lateral cephalometric radiography. On the day of aligner insertion, gingival index and plaque index will be recorded. The teeth will be isolated and cleaned with a water-pumice slurry using a rubber polishing cup mounted on a low-speed handpiece. The enamel surfaces will be rinsed and dried with oil-free compressed air, followed by conventional acid etching with 37% phosphoric acid for 30 seconds. The etched surfaces will then be rinsed for 10 seconds according to the manufacturer's instructions and air-dried until a frosty white appearance is observed. A universal adhesive (BISCO All-BOND UNIVERSAL, USA) will be applied to the etched enamel surfaces using a nylon brush, followed by gentle air thinning for 2 seconds with the air stream directed perpendicular to the enamel surface. Attachment templates will be filled with Neo Spectra™ ST Universal Composite (Dentsply Sirona), a nanohybrid composite material, and attachments will be bonded according to the aligner manufacturer's prescribed attachment positions. The composite will then be light-cured for 20 seconds. Group A (Regular-use group): Participants will use the aligner seater during the initial insertion of each new aligner for one to two days, or until the aligner is fully seated without visible gaps. Participants will be instructed to bite on the aligner seater for a few seconds while the aligner is in place. Group B (Customized-use group): In addition to the regular-use protocol described for Group A, participants will be instructed to bite on the aligner seater for a few seconds each night at bedtime throughout the study period. All participants will receive standardized written instructions regarding clear aligner care and the manufacturer's recommendations. A study-specific questionnaire will be completed to assess pain during treatment. Participants will attend follow-up visits every 30 days (after every three aligners), during which gingival index, plaque index, intraoral photographs, digital intraoral scans, and questionnaire data will be collected. Participants will also be instructed to contact the treating orthodontist immediately if attachment loss occurs. Participants will be followed for four months.
Interventions
DEVICEAligner seater
Participants use silicone aligner seaters during clear aligner therapy. The study compares two different protocols of aligner seater use: regular use and customize use.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Male and female participants. * Age between 18 and 45 years. * Mild to moderate crowding or spacing. * ANB angle between 1° and 5°. * Planned for non-extraction clear aligner treatment. * Willing and able to provide written informed consent and comply with the study protocol.
Exclusion criteria
* Craniofacial syndromes (e.g., cleft lip and/or palate) or other congenital craniofacial anomalies. * Severe crowding. * Signs and/or symptoms of temporomandibular disorders (TMD). * Previous orthodontic treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measure | Four months | Tooth movement predictability will be assessed as the absolute difference between the prescribed and achieved tooth movement in linear (mm) and angular (degrees) measurements using three-dimensional digital model superimposition. Digital models will be analyzed using Geomagic Control X software. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain during clear aligner therapy | 1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner. | Pain intensity will be assessed using a Visual Analog Scale (VAS) questionnaire at 1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner. |
| Periodontal health | Baseline and every monthly follow-up visit throughout the 4-month study period | Periodontal health will be assessed using the Bleeding on Probing (BOP) index and the Plaque Index (PI). |
Countries
Iraq
Contacts
PRINCIPAL_INVESTIGATORFarah Alaa Hussein, B.D.S.
University of Baghdad/ collage of Dentistry
STUDY_DIRECTORHadeel Adel Al-lami, Ph.D orthodontics
University of Baghdad/ collage of Dentistry
Outcome results
None listed