Periodontal Ligament Injection Versus Routine Local Infiltration, for the Non-surgical Single Posterior Maxillary Permanent Tooth Extraction: Comparative Double Blinded Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 主要终点
- the Visual Analogue Scale (VAS) scores for injections pain
研究概览
简要总结
The literature concerning the success and pain scores of PDL injection technique compared with other techniques remains controversial; whereas some studies found no significant difference in pain scores between local infiltration and PDL injection, other older studies found that pain during administration of PDL injection was described by the majority of patients either as greater than local infiltration6, or as negligible or as a less painful injection compared with other injection techniques. The aim of this study was to evaluate the efficacy of and patients' subjective responses to the PDL injection technique as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth.
详细描述
Aim: The aim of this study was to evaluate the efficacy of and patients' subjective responses to the periodontal ligament (PDL) anesthetic injection as compared to the traditional infiltration injection, for the non-surgical extraction of one posterior maxillary permanent tooth. Methods: All patients scheduled for non-surgical symmetrical maxillary posterior permanent teeth extraction in the Department of Oral and Maxillofacial Surgery (OMFS) at the University of Jordan Hospital, Amman, Jordan, over a-seven-month period, were invited to participate in this prospective randomized double blinded, split mouth study. Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) and a Verbal Rating Scale (VRS) were used to describe the pain felt during injection and extraction, respectively. Statistical significance was based on probability values of <0.05 and measured using Chi-Square and Student-t tests, and Nonparametric Mann-Whitney and Kruskal-Wallis tests.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The method of anesthesia used for the left or right sides was blinded to the patient and determined randomly by the same surgeon (MA) who was not involved in the extraction. the extraction procedure was randomly commenced by the same resident who was blinded to the anesthetic technique administered randomly by the surgeon.participiants were also blinded to the type of technique applied on each side.
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
- •The inclusion criteria were: patients who were fit for surgery under LA (classified by the American Society of Anaesthesiologists (ASA) as ASA I-ASA III); patients exhibiting full understanding of given oral instructions; and bilateral symmetrical posterior maxillary permanent teeth referred for non-surgical extractions under LA.
排除标准
- •Exclusion criteria were: the presence of acute dento-alveoalr infection; patients requiring conscious sedation or general anesthesia; patients unwilling to participate in the study; patients with ASA greater than III; patients on anti-inflammatory or recreational drugs; and patients requiring more than two additional injections in one or both sides for incomplete anesthesia.
结局指标
主要结局
the Visual Analogue Scale (VAS) scores for injections pain
时间窗: 5 minutes
The VAS composed of a 100-mm line and allowed the patient to score the pain experienced during injections as low moderate and high
次要结局
未报告次要终点
研究者
Mohammad H Al-Shayyab
Associate Professor, Assisstant Dean, Principal Investigator
University of Jordan