Comparative evaluation of the effectiveness of Stevia extract used as powder versus Amoxicillin trihydrate powder in surgical extraction of mandibular third molar among 18-45-year-old adults - A split mouth Randomized controlled trial.â€
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- VERTICAL
研究概览
简要总结
This is a split mouth randomized controlled trial to compare and evaluate the antimicrobial activity of stevia extract powder and amoxicillin trihydrate powder after surgical extraction of mandibular third molar extraction in an adult population 18 to 45 years group. The sample size was calculated as 40 patients. the sample size will be divided randomly into 2 groups consisting of 40 patients in each group using computer generated random numbers. Informed consent will be taken from the patient. The study group will consist of patients recieving stevia extract powder topically in the extraction socket followed by placement of abgel and suturing of the wound. the control group will consist of patients where administration of amoxicillin trihydrate powder topically in the extraction socket followed by abgel placement and suturing will be done. The postoperative outcomes to be assessed are presence or absence of erythema, suppuration, pain, edema, Wound dehiscence, WBC counts, mouth opening and facial measurements. These outcomes will be recorder in a proforma for each patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged between 18-45 years
- •Patients of both sexes will be included.
- •Patients with good physical and mental status.
- •Patient requiring bilateral surgical extraction of mandibular third molars.
- •Absence of any infection (pericoronitis) prior to the surgery.
- •Patients with non-palpable submandibular lymph nodes.
- •Patients who were not on antibiotics for last 7 days.
- •Patients consenting for the study.
排除标准
- •1 Patients with a known medical history 2 Febrile patients with an active infection elsewhere 3 Patients with an immune-compromised state.
- •4 Patients with a known drug and /or food allergy 5 A recent use of antimicrobial drug (in the last 7 days).
- •6 Uncooperative patients, mentally retarded patients.
- •7 Pregnant or lactating mothers.
结局指标
主要结局
VERTICAL
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
WBC COUNT
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
PAIN
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
SUPPURATION
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
Erythema of the surrounding intraoral tissues
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
AXILLARY TEMPERATURE
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
LYMPH NODES
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
MOUTH OPENING
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
HORIZONTAL
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
FACIAL MEASUREMENTS
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
Wound dehiscence
时间窗: outcomes measured at day 1 day 3 and day 7 postoperatively
次要结局
- postoperative antimicrobial activity(outcomes measured at day 1 day 3 and day 7 postoperatively)
