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临床试验/NCT04565912
NCT04565912Unknown不适用

Efficacy of Sage Extract or Chlorohexidine Mouthwashes on Streptococcus Mutans Pathogenicity by Real-time Polymerase Chain Reaction (PCR) in High Caries Risk Patients : A Randomized Clinical Trial

Cairo University0 个研究点目标入组 37 人开始时间: 2021年7月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
37
主要终点
Total bacterial count

研究概览

简要总结

In patients with high caries risk, will the use of sage extract or chlorohexidine based mouthwashes have an effect on the percentage recovery of Streptococcus Mutans (SM) and its pathogenicity detected by Real-Time Polymerase Chain Reaction (PCR) over one month follow up

详细描述

The clinical study will be held in the clinic of conservative department, Faculty of Dentistry, Cairo University. The operator in charge will be Dina Fayez Diab. Patients will be examined and selected according to inclusion and exclusion criteria, the purpose and method of the study will be explained to the selected patients for participation in the study. In the first visit , ADA caries risk assessment model will be done. Participants will be divided in to two groups according to the tested mouthwashes.

All patients will be instructed not to have a breakfast and to refrain any oral hygiene measures on the day of sample collection to avoid the influence of food consumption and contamination on the composition of saliva. The patient will sit in an erect position on the dental chair and will be given paraffin block to chew. The stimulated saliva will be collected after 2 minutes of paraffin chewing in sterile container held near the mouth. The containers will be properly labelled.

This study will be carried over one month , the saliva samples for each patients will be collected on the first dental visit. These samples will be sent to the laboratory for microbiological assessment. Patients will be provided with mouthwashes according to the tested groups and will be instructed to use it 2 times per day for 1 minute each time and no eating or drinking allowed for at least 30 minutes post rinsing. Each patient will be given the same instructions with respect to oral hygiene measures. They will be advised to continue on the same diet and will be instructed not to change their dietary habits.

Patients will come after 2 weeks for salivary samples collection and samples will be sent to laboratory for microbiological assessment. After completing the treatment for another 2 weeks , patients will come for the last dental visit to collect salivary samples which will be sent to laboratory for microbiological assessment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients will be recruited in this study, all volunteers participated will be medically free Age range 20-50
  • Patients with high caries risk assessment according to ADA caries risk assessment model High plaque index (>score 2 )
  • Non smoking patients
  • Patients with normal salivary rate ( 0.3-0.4 ml/min)
  • Not under antibiotic therapy either time of the study or up to the last month before the begging of the study
  • Male or female patients.

排除标准

  • patients with a compromised medical history.
  • Patients with low caries risk assessment according to ADA caries risk assessment model.
  • Patients with sever or active periodontal disease.
  • Patients with a history of allergy to any of drugs or chemicals used in this study.
  • Smoking patients
  • Patients with abnormal salivary rate
  • Pregnant female patients.

研究组 & 干预措施

Sage extract mouthwash

Experimental

Natural product mouthwash

干预措施: Sage extract mouthwash (Drug)

Chlorohexidine mouthwash

Active Comparator

Synthetic mouthwash

干预措施: Chlorohexidine based mouthwash (Drug)

结局指标

主要结局

Total bacterial count

时间窗: 1 month

Quantitative plating ( standard plate count or SPC) will be used to determine the number of bacteria in a culture sample. SPC reveals information on viable organisms only, bacteria colonies that are seen in the plates after incubation represent only the living organisms, not dead ones

次要结局

  • Bacterial identification(1 month)
  • Total protein profile(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dina Fayez Shebl Diab

Principle investigator

Cairo University

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