Patient-Reported Outcomes for Different Orthodontic Thermoplastics for Clear Aligners: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain intensity during clear aligner therapy
研究概览
简要总结
Clear aligner therapy is an esthetic orthodontic treatment modality that uses removable thermoplastic trays to correct dental alignment. Different thermoplastic materials, including thermoplastic polyurethane (TPU) and polyethylene terephthalate glycol (PETG), may differ in flexibility and mechanical behavior. These material differences may influence patient-reported outcomes such as pain, mucosal ulceration, tooth sensitivity, tooth mobility, and material-related allergic symptoms. This randomized, double-blind, parallel-group clinical trial will compare patient-reported outcomes in patients treated with clear aligners fabricated from TPU versus PETG. Participants requiring non-extraction clear aligner therapy for mild to moderate crowding will be randomly allocated in a 1:1 ratio to receive aligners fabricated from either PETG or TPU. Outcomes will be recorded at five predefined time points after aligner assignment and wear: T0 before aligner wear, T1 immediately after aligner insertion/wear, T2 at day 1, T3 at day 3, and T4 at day 7.
详细描述
This is a randomized, double-blind, parallel-group clinical trial conducted at the Department of Orthodontics, Institute of Dentistry, CMH Lahore Medical College, Lahore, Pakistan.
Eligible participants will be patients aged 15 to 30 years seeking orthodontic treatment with clear aligners. Patients must have permanent dentition from first molar to first molar, mild to moderate crowding less than 8 mm, and a non-extraction treatment plan.
After baseline assessment, participants will be randomized in a 1:1 ratio to receive clear aligners fabricated from PETG or TPU. Randomization will use a computer-generated sequence prepared by an independent statistician. Allocation concealment will be maintained using sealed envelopes by staff not involved in trial assessment.
The principal investigator will plan all aligner cases. Linear movements will be limited to 0.25 mm per aligner. Angular movements will be limited to 2 degrees per aligner, except torque, which will be limited to 1 degree per aligner. Each aligner will be worn for 10 days.
Patient-reported outcomes will be collected by an operator blinded to the aligner material. Participants will also be blinded to the aligner material. Outcomes include pain on a visual analog scale, ulceration or soft-tissue trauma, tooth sensitivity, tooth mobility, and symptoms suggestive of material-related allergy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double masking: participant and outcome assessor
入排标准
- 年龄范围
- 15 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patient aged between 15 and 30 years.
- •Permanent dentition, with all permanent teeth from first molar to first molar present.
- •Mild to moderate crowding less than 8 mm.
- •Non-extraction orthodontic treatment plan.
- •Ability and willingness to wear aligners for the required time.
- •Willingness to attend regular visits during orthodontic treatment.
排除标准
- •• Syndromic patients.
- •Known allergy to thermoplastic materials.
- •Patients with systemic diseases that may affect orthodontic treatment or outcome assessment.
- •Patients requiring extraction as part of orthodontic treatment.
结局指标
主要结局
Pain intensity during clear aligner therapy
时间窗: During each of the first four aligner cycles: before aligner insertion; immediately after aligner insertion; and 1 day, 3 days, and 7 days after aligner insertion.
Pain experienced by the participant will be recorded using a visual analog scale (VAS) from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain.
次要结局
- Mucosal ulceration or soft-tissue trauma related to aligner wear(During each of the first four aligner cycles: before aligner insertion; immediately after aligner insertion; and 1 day, 3 days, and 7 days after aligner insertion.)
- Tooth sensitivity(During each of the first four aligner cycles: before aligner insertion; immediately after aligner insertion; and 1 day, 3 days, and 7 days after aligner insertion.)
- Tooth mobility(During each of the first four aligner cycles: before aligner insertion; immediately after aligner insertion; and 1 day, 3 days, and 7 days after aligner insertion.)
- Allergic symptoms or material-related adverse reaction(During each of the first four aligner cycles: before aligner insertion; immediately after aligner insertion; and 1 day, 3 days, and 7 days after aligner insertion.)