Molar Incisor HypomineralisationNCT07355465
The Effect of Salvadora Persica (Miswak) Compared to Fluoridated Toothpaste on Children's Teeth Diagnosed With Molar-Incisor Hypomineralization (MIH): A Randomized Clinical Trial
A study testing Salvadora persica (miswak) and Fluoridated Toothpaste in people with Molar Incisor Hypomineralisation, run by King Abdulaziz University.
Trial summary
Molar-Incisor Hypo mineralization (MIH) was first described in 2001 as a developmental enamel defect . It is a condition in which the enamel of at least one first primary molar is affected with a qualitative defect causing abnormal translucency appearing as demarcated opacities; The permanent incisors and second… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar Incisor Hypomineralisation
- What is being tested?
- Salvadora persica (miswak) and Fluoridated Toothpaste
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2026to 30 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children with age ranged between 6-12 years old
- Presence of at least one first permanent molar and incisor diagnosed with MIH.
- The MIH-affected teeth will have a clinical presentation of white, creamy, yellow, or brown demarcated opacities
Who cannot join
- Medically compromised children.
- Unwillingness to participate or be randomly assigned to the study groups.
- Receiving treatment for controlling MIH other than fluoride application
About this study
Molar-Incisor Hypo mineralization (MIH) was first described in 2001 as a developmental enamel defect . It is a condition in which the enamel of at least one first primary molar is affected with a qualitative defect causing abnormal translucency appearing as demarcated opacities; The permanent incisors and second primary molars can also be affected . MIH has adverse consequences on the oral health and child's quality of life. It increases the risk of caries, discomfort and teeth sensitivity .
MIH management comprises a variety of treatment options ranging from total caries removal to the polar opposite treatment option of no caries removal and non-invasive methods used to prevent caries progression . Dental caries prediction and prevention are now more important than dental caries diagnosis and treatment. Recently, the reasons for repairing dental cavities have been narrowed, and caries prevention is being used to reduce caries . Salvadora persica, commonly known as Miswak was used as a toothbrush for many years among many countries . It was reported to have a significant effect on oral health and caries prevention .Other studies have found a consistent link between the use of Miswak and a reduction in oral bacteria. However, a comprehensive assessment of using Miswak in the treatment and control of MIH among young children has yet to be conducted.
Therefore, the aim of this clinical trial is to assess the effect of SalvadoraPersica and fluoridated toothpaste on controlling hypersensitivity and preventing caries among children with MIH in primary schools. Additionally, this trial will evaluate the shade of the hypo-mineralized enamel before and after using SalvadoraPersica and fluoridated toothpaste
- Conditions
- Molar Incisor Hypomineralisation
- Being tested
- Salvadora persica (miswak), Fluoridated Toothpaste
- Medical subject headings
- Molar Hypomineralization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvadora persica (miswak)Other
Salvadora persica (miswak) has been traditionally used as a natural toothbrush across various cultures for centuries. It contains several biologically active compounds, including fluoride, silica,
Fluoridated ToothpasteDevice
Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite.
| Study group | Role | What they receive |
|---|---|---|
| Salvadora Persica (Miswak) | Experimental | Intervention Group:
Participants in this group will be provided with Salvadora persica (miswak) sticks and receive training on the correct technique for its use. Miswak sticks, uniform in length and width, supplied fresh from Jeddah Central Market, Saudi Arabia, to the subjects in the test group.
In this group, subjects will be instructed to brush with the miswak using the rolling technique, advised to use it three times a day under a parent's supervision, and shown how to keep it fresh by cutting off the edge of the miswak every day and storing it in the refrigerator at night. Receives: Other: Salvadora persica (miswak) |
| Fluoridated Toothpaste Group | Active comparator | Control Group:
Participants in this group were instructed to use only fluoridated toothpaste as part of their oral hygiene routine. Oral hygiene instructions will be given for both groups. Modified bass technique for tooth brushing twice daily, 10 seconds per quadrant, with a 1450 ppm fluoride concentration Receives: Device: Fluoridated Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Assess the effect of Salvadora Persica on the color of MIH-affected teeth compared to brushing with fluoridated toothpaste
The VITA Easyshade® advance spectrophotometer (VITA Zahnfabrik, Bad Sackingen, Germany) will be used to assess the color of MIH-affected permanent incisors and the adjacent sound enamel
Measured: Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3)
Secondary outcomes (1)
the effectiveness of Salvadora Persica on the hypersensitivity of MIH-affected teeth compared to brushing with fluoridated toothpaste
Hypersensitivity can be measured using a visual analog scale (VAS) and the Schiff sensitivity scale to rate patients' pain This scale ranges from zero, representing "No Pain," to 10, representing the "Worst Pain Possible," and is categorized into four levels: mild (1-3), moderate (4-6), severe (7-9), and very severe to worst pain (10). The Schiff Cold Air Sensitivity Scale is a 4-point scale used to assess dentin hypersensitivity. A score of zero indicates no sensitivity, one signifies mild sensitivity without a request to stop the stimulus, two represents moderate sensitivity with a request to stop or visible discomfort, and three indicates severe sensitivity with a request to stop and physical withdrawal.
Measured: Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start29 Jan 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Molar Incisor HypomineralisationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba sabbagh, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07355465
- Sponsor's protocol ID
- 130-10-24
- Status last verified
- Jan 2026
- First submitted
- 20 Nov 2025
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Salvadora Persica (Miswak) Compared to Fluoridated Toothpaste on Children's Teeth Diagnosed With Molar-Incisor Hypomineralization (MIH): A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07355465
- Acronym / sponsor ID
- 130-10-24
- Conditions
- Molar Incisor Hypomineralisation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 29 Jan 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Molar-Incisor Hypo mineralization (MIH) was first described in 2001 as a developmental enamel defect . It is a condition in which the enamel of at least one first primary molar is affected with a qualitative defect causing abnormal translucency appearing as demarcated opacities; The permanent incisors and second primary molars can also be affected . MIH has adverse consequences on the oral health and child's quality of life. It increases the risk of caries, discomfort and teeth sensitivity .
MIH management comprises a variety of treatment options ranging from total caries removal to the polar opposite treatment option of no caries removal and non-invasive methods used to prevent caries progression . Dental caries prediction and prevention are now more important than dental caries diagnosis and treatment. Recently, the reasons for repairing dental cavities have been narrowed, and caries prevention is being used to reduce caries . Salvadora persica, commonly known as Miswak was used as a toothbrush for many years among many countries . It was reported to have a significant effect on oral health and caries prevention .Other studies have found a consistent link between the use of Miswak and a reduction in oral bacteria. However, a comprehensive assessment of using Miswak in the treatment and control of MIH among young children has yet to be conducted.
Therefore, the aim of this clinical trial is to assess the effect of SalvadoraPersica and fluoridated toothpaste on controlling hypersensitivity and preventing caries among children with MIH in primary schools. Additionally, this trial will evaluate the shade of the hypo-mineralized enamel before and after using SalvadoraPersica and fluoridated toothpaste
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvadora Persica (Miswak) | Experimental | Other: Salvadora persica (miswak)Intervention Group: Participants in this group will be provided with Salvadora persica (miswak) sticks and receive training on the correct technique for its use. Miswak sticks, uniform in length and width, supplied fresh from Jeddah Central Market, Saudi Arabia, to the subjects in the test group. In this group, subjects will be instructed to brush with the miswak using the rolling technique, advised to use it three times a day under a parent's supervision, and shown how to keep it fresh by cutting off the edge of the miswak every day and storing it in the refrigerator at night. |
| Fluoridated Toothpaste Group | Active comparator | Device: Fluoridated ToothpasteControl Group: Participants in this group were instructed to use only fluoridated toothpaste as part of their oral hygiene routine. Oral hygiene instructions will be given for both groups. Modified bass technique for tooth brushing twice daily, 10 seconds per quadrant, with a 1450 ppm fluoride concentration |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children with age ranged between 6-12 years old
Key exclusion criteria (3 listed)
- Medically compromised children.
- Unwillingness to participate or be randomly assigned to the study groups.
- Receiving treatment for controlling MIH other than fluoride application
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salvadora persica (miswak)Salvadora persica (miswak) has been traditionally used as a natural toothbrush across various cultures for centuries. It contains several biologically active compounds, including fluoride, silica, | Other | Salvadora Persica (Miswak) |
| Fluoridated ToothpasteParticipants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite. | Device | Fluoridated Toothpaste Group |
Primary outcome
To Assess the effect of Salvadora Persica on the color of MIH-affected teeth compared to brushing with fluoridated toothpaste
Time frame: Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3)
The VITA Easyshade® advance spectrophotometer (VITA Zahnfabrik, Bad Sackingen, Germany) will be used to assess the color of MIH-affected permanent incisors and the adjacent sound enamel
1 secondary outcome
the effectiveness of Salvadora Persica on the hypersensitivity of MIH-affected teeth compared to brushing with fluoridated toothpaste
Time frame: Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Salvadora persica (miswak) and Fluoridated Toothpaste in people with Molar Incisor Hypomineralisation, run by King Abdulaziz University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To Assess the effect of Salvadora Persica on the color of MIH-affected teeth compared to brushing with fluoridated toothpaste (time frame: Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.