Clinical trial NCT04561960: Efficacy of Miswak in Oral Hygiene Maintenance
Official title: Efficacy of Miswak When Compared to Fluoridated Toothpaste for the Maintenance of Oral Hygiene in Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Plaque
Keywords: miswak
siwak
S. persica
chew stick
Lead sponsor: Riyadh Elm University
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

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. In a previous study found that the periodontal health of miswak users was better than the periodontal health of manual toothbrush users, also it was concluded that miswak is more effective than tooth brushing for reducing plaque and gingivitis when preceded by professional instruction regarding its correct application.

Another research reported the opposite thing, Punit Patel and S. Shruthi studied the clinical effects of miswak as an adjunct to tooth brushing on gingivitis clearly and they find that the indication of miswak cannot replace the toothbrush, but can be used an adjunct to toothbrush, utilizing the mechanical efficacy of toothbrush and chemical effects of miswak.

However, it was concluded that "The use of S. persica miswak alone or in combination with conventional toothbrushes, when performed judiciously, will result in superior oral health and hygiene." 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 is a lot of controversy whether the miswak alone can be used for effective plaque removal and good gingival health or should it be only used as an adjunct to tooth brushing.

In this study we will determine whether the miswak can be used as the chief tool in oral health rather than an adjunct to tooth brushing. We will also determine whether toothpaste using the miswak extract can be as effective as the normal fluoridated toothpaste.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Base line Plaque Score
timeFrame: Baseline
measure: Plaque Score change at 1 week
timeFrame: One week
measure: Plaque Score change at 2 weeks
timeFrame: Two weeks
measure: Baseline Bleeding Score
timeFrame: Baseline
measure: Bleeding Score change at 1 week
timeFrame: One week
measure: Bleeding Score change at 2 weeks
timeFrame: Two weeks
Secondary outcomes:
measure: Presence of White spot lesions
timeFrame: Two weeks
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
Study officials:
affiliation: Head of IRB, REU
name: Omar Alkadhi, MSc
role: STUDY_CHAIR
affiliation: Assistant Professor, prothetic dental department, REU
name: Sarah S Aburaisi, MSc
role: PRINCIPAL_INVESTIGATOR
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