Comparison of Patient-reported Pain After Initial Archwire Placement With Three Types of Nickel-titanium Archwires: a Prospective Triple-blind, Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Pain score via Visual Analogue Score
研究概览
简要总结
Three different types of 'archwires' can be used in Orthodontic treatment, wire choice is decided by treating Orthodontist based on professional preference since research shows that all types are equally effective.
It is possible that one type of wire engenders more patient discomfort. This study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.
详细描述
Orthodontic treatment with fixed appliances has the potential to induce pain in patients. At the beginning of treatment, the orthodontist must determine which initial orthodontic archwire to insert. Among the more popular choices for initial leveling and aligning of the dental arches are small-sized, round-diameter nickel-titanium archwires. Various types of nickel-titanium (NiTi) archwires exist including stabilized martensitic wires (ie classic Nitinol), active austenitic wires (superelastic NiTi) and active martensitic wires (thermoelastic NiTi). The efficacy of these wire types has been heavily researched with no significant differences in the alignment timing of the dentition (treatment time to reach the final archwire). Pain differences from these wires has been inconclusive from conflicting past studies. It is of critical importance to determine whether one or more of these archwires leads to more discomfort for the patient than the others.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigator will assemble the opaque, sealed envelopes containing the archwires. The envelopes will be labeled "A", "B" or "C" corresponding to 0.016" Nitinol (3M Unitek, Monrovia, CA), 0.016" 27o CuNiTi (Ormco, Glendora, CA) or 0.016" 35o CuNiTi (Ormco, Glendora, CA) respectively. Randomization sequences will be created by using Research Randomizer online software. The investigator will enroll patients into the study. This trial will be completed with two blocks of 63 subjects each, one block per year, with subject randomization within each block.
An independent third party will maintain possession of all envelopes and distribute as needed once a subject is enrolled and ready to receive fixed orthodontic appliances. The same independent third party will maintain a log with subject identification and consent forms.
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, with no significant systemic diseases or complications or special needs
- •Requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment
- •All banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth).
- •Any planned dental extractions that is part of the orthodontic treatment plan must be carried out at least 3 weeks prior to or after initial orthodontic appliance bonding.
- •Age 12 years or older
排除标准
- •Currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines
- •Currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period
- •Metal-type (Nickel) allergies
- •Less than 12 years old
- •Same day use of analgesics prior to bonding
- •Treatment requiring dental extractions prior to or immediately after bonding of fixed appliance
研究组 & 干预措施
A: 0.016" Nitinol
0.016" Nitinol (3M Unitek, Monrovia, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
干预措施: 3M Unitek 0.016 orthodontic archwire (Device)
B: 0.016" Ormco 27oC NiTi
0.016" Ormco 27oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
干预措施: Device: 0.016" Ormco 27oC NiTi orthodontic archwire (Device)
C: 0.016" Ormco 35oC NiTi
0.016" Ormco 35oC NiTi (Ormco, Glendora, CA) archwire to be tied to the fixed orthodontic brackets at the initial bonding appointment.
干预措施: Device: 0.016" Ormco 35oC NiTi orthodontic archwire (Device)
结局指标
主要结局
Pain score via Visual Analogue Score
时间窗: 1 hour, 4 hour, 24 hour, 4 day and 7 day
The primary outcome is the change in pain experienced by the study participant over the first week of therapy after insertion of the archwire. Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line is no pain where the right end is maximum (unimaginable) pain. The specific pain indicated is in the number of millimeters from the left end of the line. This is called the Visual Analogue Score (VAS) where the higher the number the more intense the pain. The difference in VAS pain scores from the initial VAS after archwire insertion (1 hour) to each measurement time (4 hour, 24 hour, 4 day and 7 day) over 7 days will indicate the change pain experience for each study participant. For each time point the mean and standard deviation of the change in VAS pain scores for the experimental groups will be calculated and compared for statistically significant differences.
次要结局
未报告次要终点