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临床试验/NCT04561960
NCT04561960已完成4 期

Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults

Riyadh Elm University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2020年9月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Plaque Score change at 1 week

研究概览

简要总结

Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. The popularity of Miswak in Arab countries has meant that there have been several studies that have confirmed the ability of miswak to provide effective mechanical and chemical cleansing when used as an adjunct to other oral hygiene aids.

Fluoridated tooth paste and manual tooth brushes have been the standard of clinical preventive dental care for over 50 years.However, the objection to the use of fluorides by some parents has meant that these pastes are not universally accepted.

There are several non-fluoridated pastes available in the market that include the extract of miswak. There are few studies that have compared these pastes to fluoridated pastes and to miswak as a stand alone agents.

Miswak has been recommended by world health organization in 1987 for oral hygiene because of its availability, beneficial effect and affordability.

It has been stated that "Several clinical studies have confirmed that the mechanical and chemical cleansing efficiency of miswak chewing sticks are equal and at times greater than that of the toothbrush" this was mentioned and reviewed that it is in fact right but only when used in a regular constant matter with a proper and effective way of plaque removal. This study aims to use a cross over model to study the effectiveness of miswak as a stand alone agent in maintaining oral hygiene in young adults and compare it miswak containing toothpastes and fluoridated toothpastes when used with a manual tooth brush.

详细描述

Oral hygiene is the key of maintaining human's mouth at a state of equilibrium and free of diseases (e.g. cavities, dental decay, gingivitis, halitosis). Poor oral hygiene can significantly affect the quality of life and has a considerable influence on diet, sleeping, social communication, psychological status, and by being less productive at work.

Therefore, oral hygiene is essential for general health and well-being. Oral hygiene measures include toothbrush which is the most commonly used method for plaque control. However, miswak is a commonly used method in many developing countries.

Miswak has a widespread among religious, rural and developing countries for its spiritual impact since the use of miswak was advised by prophet mohammed (peace be upon him) centuries ago as he said "had I not thought it difficult for my ummah, I would have commanded them to use miswak before every prayer".

Miswak has been recommended by world health organization for oral hygiene because of its availability, beneficial effect and affordability. Previous chemical examinations changed our idea in Miswak which showed us that miswak sticks contain natural ingredients which benefits our oral health. Miswak extracts appear to have different beneficial biological properties like anti-bacterial and anti-fungal effects which will play a high role in oral hygiene measures.

Multiple researches suggested that miswak has anti-cariogenic effects. several studies concluded that Chewing sticks (miswak) has revealed parallel and at times greater mechanical and chemical cleansing of oral tissues as compared to a toothbrush.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 25 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy adults
  • Able to perform their own oral hygiene
  • Dental students

排除标准

  • Active Dental Caries
  • Uncontrolled chronic medical conditions
  • History of drug and/or treatment that reduces salivary flow
  • Currently undergoing orthodontic treatment
  • Missing index teeth #16, #12, #24, #36, #32, #44

研究组 & 干预措施

Control

Active Comparator

Participants will be trained to perform oral hygiene using the modified bass technique.

The participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride

干预措施: Fluoride toothpaste (Drug)

Control

Active Comparator

Participants will be trained to perform oral hygiene using the modified bass technique.

The participants will be asked to brush their teeth twice daily using a manual tooth brush and fluoridated toothpaste containing 1450ppm of fluoride

干预措施: Toothbrush (Device)

Miswak

Experimental

Participants will be trained to chew and condition a miswak stick Participants will be asked to use the miswak stick twice daily

干预措施: Miswak Stick (Device)

Miswak Paste

Experimental

Participants will be trained to perform oral hygiene using the modified bass technique.

The participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract

干预措施: Toothpaste Product (Drug)

Miswak Paste

Experimental

Participants will be trained to perform oral hygiene using the modified bass technique.

The participants will be asked to brush their teeth twice daily using a manual tooth brush a non-fluoridated toothpaste containing miswak extract

干预措施: Toothbrush (Device)

结局指标

主要结局

Plaque Score change at 1 week

时间窗: One week

Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque

Plaque Score change at 2 weeks

时间窗: Two weeks

Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque

Bleeding Score change at 1 week

时间窗: One week

Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation

Bleeding Score change at 2 weeks

时间窗: Two weeks

Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation

Base line Plaque Score

时间窗: Baseline

Silness-Löe Index: #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-3, 0 being absent from plaque

Baseline Bleeding Score

时间窗: Baseline

Gingival Index (Loe \& Silness 1963): #16, #12, #24, #36, #32, #44Missing teeth are not substituted. 0-4 . 0 being absent from inflammation

次要结局

  • Presence of White spot lesions(Two weeks)

研究者

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

Sarah Samer Aburaisi

Principal Investigator

Riyadh Elm University

研究点 (1)

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