A Randomized Clinical Trial of the Effectiveness of Acupressure in Relieving Orthodontic Pain
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Comparative Evaluation of Acetaminophen and Acupressure for Pain Management in Orthodontic Treatment
研究概览
简要总结
Orthodontic treatment with fixed appliances often causes pain, which peaks within 24 hours after archwire placement and lasts for several days. Patients commonly use analgesics such as acetaminophen to relieve pain, as it has minimal impact on tooth movement compared to NSAIDs. However, nonpharmacological approaches, such as acupressure, may offer an alternative method for pain relief. Acupressure is a traditional Chinese medicine technique that involves applying pressure to specific points on the body to reduce pain and promote relaxation.
This randomized clinical trial aims to compare the effectiveness of acupressure versus acetaminophen in relieving orthodontic pain during the first five days after initial archwire placement.
Study Design and Methodology
- A parallel-group, single-center, blinded, randomized trial at Almina Dental Clinics.
- Participants will be randomly assigned to one of two groups (1:1 ratio):
- Acetaminophen Group: Participants will take 500 mg of acetaminophen up to three times in the first 24 hours after archwire insertion.
- Acupressure Group: Participants will apply pressure on two acupressure points (St 6 and St 3) up to five times in the first 24 hours. If pain persists, they may take acetaminophen.
- Pain levels will be recorded using a Visual Analog Scale (VAS) twice daily for five days.
- The Mann-Whitney U test will be used to compare pain scores between groups.
Eligibility Criteria
Inclusion Criteria:
- Patients aged 12 years and older with full permanent dentition (excluding third molars).
- Undergoing fixed orthodontic treatment for the first time.
- Minimum crowding of 4 mm according to Little's Irregularity Index.
- No systemic diseases, periodontal diseases, or acute/chronic oral pain.
Exclusion Criteria:
- Chronic use of analgesic medications.
- Allergy or contraindications to acetaminophen.
- Pregnant patients or those with cleft lip/palate.
- Recent toothache or requiring tooth extractions.
- Female patients during their menstrual period.
Study Significance
This study evaluates whether acupressure can be an effective, nonpharmacological alternative to acetaminophen for managing orthodontic pain. If proven effective, acupressure could offer a safe, noninvasive method for pain relief with fewer side effects.
Ethical Considerations & Dissemination
- The study protocol will be reviewed and approved by an ethics committee.
- The research is self-funded.
- Results will be published in a scientific journal to contribute to orthodontic pain management research.
详细描述
Introduction
Orthodontic treatment with fixed appliances is often associated with pain and discomfort, peaking within the first 24 hours after archwire placement and gradually subsiding over five to six days. This pain is caused by pressure-induced ischemic changes in the periodontal ligament, leading to sterile necrosis and inflammation. The release of biochemical mediators such as prostaglandins, histamine, serotonin, and bradykinin contributes to the sensation of pain.
Pharmacological interventions, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen, are the most commonly used pain management methods. However, NSAIDs can slow tooth movement by inhibiting prostaglandin synthesis, while acetaminophen, though considered safer, may still cause adverse reactions in some individuals. Given these concerns, nonpharmacological pain relief methods, such as acupressure, have gained interest.
Acupressure is a mechanical technique rooted in traditional Chinese medicine, where pressure is applied to specific acupoints to promote circulation, reduce muscle tension, and stimulate the body's natural pain-relieving mechanisms. Unlike acupuncture, which involves the insertion of needles, acupressure is a noninvasive therapy that can be easily self-administered. Studies have explored its effectiveness in various medical and dental conditions, but its role in orthodontic pain management remains under-researched.
Study Objectives
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
In this study, investigators and outcomes assessors will be blinded to the intervention groups to minimize bias. The investigators responsible for data collection and pain assessment will not know whether participants received acupressure or acetaminophen. Similarly, the outcomes assessors analyzing the Visual Analog Scale (VAS) scores will be blinded to the group assignments to ensure unbiased statistical analysis. However, due to the nature of the interventions, participants cannot be blinded, as they will actively perform acupressure or take acetaminophen.
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
- •Patients who have agreed to the research procedures and signed an informed consent form.
- •Upper and lower comprehensive fixed orthodontic appliances (with no history of previous orthodontic treatment).
- •They have a minimum crowding of 4mm according to Little's irregularity index (with no impactions/unerupted teeth).
- •Patients with no systematic/periodontal diseases.
- •If tooth extraction is needed, it is performed at least two weeks before fixed appliance placement or delayed after the study is completed.
- •Patients aged 12 years and above with full permanent dentition (excluding the third molars)
- •No current acute or chronic pain in the oral cavity.
排除标准
- •Patients who have been using analgesic medications chronically or require prophylactic antibiotic coverage.
- •Patients who are currently taking analgesics or antibiotics.
- •Female patients being in the menstrual period.
- •Patients with contraindications to the use of paracetamol (Hypersensitivity or anaphylaxis to any acetaminophen-like or -containing agents, in conjunction with alcohol, and patients with severe liver disease).
- •Patients who have recently experienced a toothache.
- •Patients who have a cleft lip or palate.
- •Pregnant patients.
研究组 & 干预措施
Acetaminophen Group
Participants in this group will be instructed to take acetaminophen 500mg, up to three times within the first 24 hours following the insertion of the archwire. The purpose of this intervention is to alleviate pain associated with orthodontic treatment. The analgesic effect of acetaminophen, which acts centrally to reduce pain, will be evaluated based on self-reported pain levels recorded using a visual analog scale (VAS) over the five-day post-bonding period.
干预措施: Acetaminophen (Drug)
Acupressure Group
Participants in this group will be instructed on how to apply acupressure to two specific points: the Jaw Chariot (St 6) and Facial Beauty (St 36). They will be guided to apply firm pressure to these points up to five times within the first 24 hours after archwire insertion to alleviate pain associated with orthodontic treatment. The effectiveness of acupressure in pain management will be evaluated based on self-reported pain levels recorded using a visual analog scale (VAS) over the first five days post-bonding. If pain persists, participants may use acetaminophen as a supplementary pain management option.
干预措施: Acupressure (Procedure)
结局指标
主要结局
Comparative Evaluation of Acetaminophen and Acupressure for Pain Management in Orthodontic Treatment
时间窗: From archwire insertion to 5 days post-bonding
This study aims to compare the effectiveness of two pain management methods-acetaminophen (500mg) and acupressure-following the insertion of an archwire in orthodontic patients. Pain perception will be measured using a Visual Analog Scale (VAS), where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). The study will assess pain relief over the first five days post-treatment, with pain levels recorded twice daily on days 2 to 5, and once on day 1. Patients will either take acetaminophen or perform acupressure on specific points of the body (St 6 and St 36) to relieve discomfort. The goal is to determine which method provides more effective pain relief during the early stages of orthodontic treatment.
次要结局
未报告次要终点
研究者
Ayat M. Hussein
Principal Investigator
University of Baghdad