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临床试验/CTRI/2020/08/027305
CTRI/2020/08/027305已完成4 期

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€

Dr Nidhi Pandey1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年8月24日最近更新:

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)

研究者

发起方
Dr Nidhi Pandey
申办方类型
Other [self]

研究点 (1)

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