Cardiovascular Effects of Racemic Epinephrine Pellets Used in Pediatric Restorative Dentistry Under General Anesthesia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Cardiovascular Outcomes
研究概览
简要总结
The primary aim of this study was to determine if topical racemic epinephrine pellets affect heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP) or mean arterial pressure (MAP) in children receiving dental care under general anesthesia (GA). Thirteen patients requiring prefabricated zirconia crowns on both primary maxillary first molars were recruited into a split-mouth randomized controlled pilot study. Patients received a continuous infusion of propofol and remifentanil with inhaled nitrous oxide/oxygen. After patient randomization and tooth preparation, either saline pellets (control) or racemic epinephrine pellets (treatment) were applied directly to gingival tissue. Vital sign measurements were recorded for 5 minutes. The procedure was repeated with either control or treatment on the contralateral side.
详细描述
Dental caries is the most common chronic disease of childhood. 3-6% of US children experience early childhood caries, a condition that may necessitate restorative dental treatment. Prefabricated crowns are the treatment of choice for children with rampant caries involving large or multiple surface lesions or developmental defects. In such situations, crowns reinforce the tooth and provide increased durability and longevity over intracoronal restorations such as fillings. They also reduce the chance that the tooth will experience recurrent decay.
In routine clinical practice, preformed metal crowns, also known as stainless steel crowns (SSC) are frequently indicated due to their extreme durability, relatively low cost, and minimal technique sensitivity. Stainless steel crowns (SSC) are no longer the only standard of care in restoring primary teeth. Although SSCs are highly effective, esthetics can be a concern for parents. Prefabricated zirconia crowns provide an esthetic solution. Zirconia is a crystalline dioxide of zirconium that has mechanical properties similar to those of metals while its color is similar to that of teeth. According to a recent randomized controlled trial, both SSC and zirconia crowns proved to be an excellent choice for molar teeth full coverage restorations. However, zirconia crowns performed better from the standpoint of esthetics, gum tissue response and plaque retention. (Abdulhadi Bashaer S, Abdullah Medhat M, et al. Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth. Journal of pediatric dentistry. 2017, Vol 5, issue 1; 21-27.)
Both Stainless steel crown and zirconia crown preparations include removing caries, followed by reducing the height of the tooth by 1.5 mm, reducing the sides of the tooth to make the pre-fabricated crown fit on the tooth. The SSC preparation requires subgingival reduction 1-2 mm below the gumline on anterior and posterior surfaces (not medial and lateral). The only additional preparation step that zirconia crown preparation involves is medial and lateral reduction of the tooth; therefore, there is little additional time that is needed for preparation of the crown since the only difference is the depth of the side reduction and preparing it circumferentially. In addition, the Primary Investigator (PI) is the provider who will be treating all patients. The PI is an experienced pediatric dentist and has been providing both types of crowns to patients under general anesthesia every week for many years.
The average time for a dental procedure under general anesthesia is between 1-3 hours. Factors that increase time include extent of disease, number of fillings/crowns placed, and pediatric dentist's experience.
The pediatric dentist that will be doing the surgery on all patients has been practicing for many years and has prepared thousands of SSC and zirconia crowns. Therefore, it is not anticipated that it will require additional time to prepare the zirconia crowns versus stainless steel crowns.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children ages 2-9 years undergoing general anesthesia for comprehensive dental treatment at the University of Washington Center of Pediatric Dentistry.
- •Healthy patients according to the American Society of Anesthesiologists (ASA) classification I or II.
- •Patients who have caries lesions requiring prefabricated crowns on primary maxillary first molars #B and #I.
排除标准
- •Pediatric patients with any severe systemic illness (ASA Classification III or greater).
- •Pediatric patients with known cardiac arrhythmia, cardiovascular disease, diabetes and thyroid disease.
- •Patients who are taking anti-arrhythmic, antihypertensive, or ionotropic medications.
- •Patients who would need pulpotomy or pulpectomy treatment on primary maxillary first molars #B and I.
研究组 & 干预措施
Control
Saline Pellet
干预措施: HemeRX epinephrine pellets (Drug)
Intervention
Racemic Epinephrine Pellet
干预措施: HemeRX epinephrine pellets (Drug)
结局指标
主要结局
Cardiovascular Outcomes
时间窗: 5 minutes
To determine blood pressure change of patients receiving treatment with topical racemic epinephrine compared to those receiving a placebo.
次要结局
- Hemostasis Efficacy(5 minutes)
研究者
Travis Nelson
Clinical Associate Professor, School of Dentistry
University of Washington
