Efficacy of Pressure Massage and Topical Gel on Pain During Inferior Alveolar Nerve Block and Maxillary Anterior Injections: A Single-Blind Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 主要终点
- Pain rate using Visual Analog Scale(VAS)
研究概览
简要总结
Eighty patients with inclusion criteria will participate in this studyEach patient will receive an injection in one of the following groups according to the random number table:
- Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)
- Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB
- Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)
- Group TGI: Topical gel with a MAI. Immediately after the injection, patients will be asked to record the amount of pain they felt during needle penetration and injection using VAS form.Data will be analyzed using ANOVA and t-test.
详细描述
Eighty patients will be requested to take participate in this study after signing a written consent form. The inclusion criteria for the participants are as follows: 18-65 years old, having no systemic disease, not pregnant or beast feeding, having a mandibular premolar/molar or a maxillary anterior tooth with the diagnosis of normal pulp, reversible pulpitis or asymptomatic irreversible pulpitis (no or mild tenderness to percussion, normal periapical radiographic appearance), not taking analgesics, sedative or anti-anxiety medication and no intra oral injection at the treatment area, during the last 24 hours. By using a 170 mm Visual Analogue Scale (VAS), patients with pain less than or equal to 54 are classified as having asymptomatic irreversible pulpitis. The way to use the VAS will be explained to the patients prior to the procedure.
Each patient will receive an injection in one of the following groups according to the random number table:
- Group TPMB: Topical pressure and massage with an Inferior alveolar nerve block (IANB)
- Group TGB: Topical gel of 20% Benzocain (Master-Dent, Monroe, NC) with IANB
- Group TPMI: Topical pressure and massage with a maxillary anterior infiltration (MAI)
- Group TGI: Topical gel with a MAI
All the injections will be performed using an aspirating syringes containing 1.8 ml of lidocaine with 1:80000 epinephrine (2%Persocaine_E; Darupakhsh, Tehran, Iran) and 28-guage needles by a single operator (N.M.A). Immediately after the injection, patients will be asked to record the amount of pain they felt during needle penetration and injection using VAS form. If the patient is subjected to more than one injection during the root canal treatment, only the first injection will be subjected to the evaluation. Recording of the acquired data from the VAS forms will be done by another operator (P.M) who will be unaware of the patients' categorization.
Data will be analyzed using ANOVA and t-test with the significance level of p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients ranged18-65 years old
- •No systemic disease
- •Non pregnant or beast feeding
- •A mandibular premolar/molar or a maxillary anterior tooth with the diagnosis of normal pulp, reversible pulpitis or asymptomatic irreversible pulpitis (Heft Parker visual analogue scale ≤ 54)
- •Need dental treatment
- •Not taking analgesics, sedative or anti-anxiety medication during the last 24 hours
- •No intra oral injection at the treatment area during the last 24 hours
排除标准
- 未提供
研究组 & 干预措施
Topical Pressure Massage Block injection
Topical pressure massage at site of alveolar nerve block injection.
干预措施: Topical pressure massage (Other)
Topical Anesthetic Gel Block injection
Topical anesthetic gel (20% Benzocain) at site of inferior alveolar nerve block injection.
干预措施: 20% Benzocain (Master-Dent, Monroe, NC) (Drug)
Topical Pressure Massage Infiltration
Topical pressure massage at site of maxillary anterior infiltration
干预措施: Topical pressure massage (Other)
Topical Anesthetic Gel Infiltration
Topical anesthetic gel (20% Benzocain) at site of maxillary anterior infiltration
干预措施: 20% Benzocain (Master-Dent, Monroe, NC) (Drug)
结局指标
主要结局
Pain rate using Visual Analog Scale(VAS)
时间窗: 2 minutes
Topical anesthetic gel / pressure massage will be applied at the site of injection for 1 minute and anesthetic solution will be done during 1 minute
次要结局
未报告次要终点
研究者
Nahid Mohammadzadeh Akhlaghi
Associate Professor
Azad University of Medical Sciences