A Prospective Study of Immediate Versus Delayed Treatment of Odontogenic Infections
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 主要终点
- Change in diagnosis
研究概览
简要总结
The objective of this study is to compare the physiologic resolution of dental infections between immediate tooth extraction (control group) and administration of systemic antibiotics and delayed extraction (study groups 1 and 2). A secondary objective is two compare two different antibiotic regimens in the delayed extraction groups (study group 1 and 2).
详细描述
This is a prospective partially randomized clinical trial. Patients 2-11 years old who have a vestibular swelling associated with an odontogenic infection are being studied. Subjects will self-select into the control or study group. All subjects will be offered to have the tooth extracted on the day of diagnosis, and if this treatment is chosen they will join the control group (group 1). Subjects who defer treatment will be placed on amoxicillin and will be placed into the study group. The study group will be randomized into two parallel study groups that either have average dose antibiotics for 10 days (group 2), or maximum dose antibiotics for 5 days (group 3).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who present to the dental clinic or Boston Children's Hospital emergency room
- •Odontogenic origin associated with a primary tooth and limited to the buccal vestibule only
- •Ages of 2-11 years old
- •Primary Caregiver present
- •English speaking
- •American Society of Anesthesiologists (ASA) classification of I
- •None or current systemic antibiotic therapy regimen < 24 hours
- •Able to take medication orally
- •Those patients who choose to participate in the study
排除标准
- •Infection that has spread beyond the buccal vestibule, or not detectable
- •Infection is associated with a permanent adult tooth
- •Ages of <2 years old or >11 years old
- •American Society of Anesthesiologists classification of II or greater or poor general health.
- •Renal impairment
- •Immunosuppressive disease
- •Recent antibiotic therapy in the last 1 to 30 days
- •Allergy to penicillin
- •Unable to take oral medications
- •Decline participation
研究组 & 干预措施
Extraction Only
Immediate extraction of infected tooth without antibiotic prescription.
干预措施: Tooth extraction (Procedure)
Average Dose Antibiotic
Average dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group)
干预措施: Amoxicillin (Drug)
Average Dose Antibiotic
Average dose antibiotic therapy(25 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 10 days and receive tooth extraction on day 10 (25 patients). (*given the average weight of a 12 year old is 45 kilos, we do not expect that we will reach the maximum dose in this group)
干预措施: Tooth extraction (Procedure)
High Dose Antibiotic
High dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients)
干预措施: Amoxicillin (Drug)
High Dose Antibiotic
High dose antibiotic therapy (45 mg/kg/day in divided doses every 12 hours (maximum 875 mg/dose)) for 5 days and receive tooth extraction on day 10 (25 patients)
干预措施: Tooth extraction (Procedure)
结局指标
主要结局
Change in diagnosis
时间窗: Infection will be monitored at days 0, 5, 10 and 20.
Tooth infection not clinically detectable
次要结局
- Measure of pediatric oral health-related quality of life: the POQL(Survey of quality of life at days 0, 5, 10 and 20.)
研究者
Keri Discepolo
Associate Dentist
Boston Children's Hospital