The Effect of Salvadora Persica (Miswak) Compared to Fluoridated Toothpaste on Children's Teeth Diagnosed With Molar-Incisor Hypomineralization (MIH): A Randomized Clinical Trial

January 20, 2026 updated by: Heba sabbagh, King Abdulaziz University

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Medically compromised children.
  • Unwillingness to participate or be randomly assigned to the study groups.
  • Receiving treatment for controlling MIH other than fluoride application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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,
Active Comparator: Fluoridated Toothpaste Group

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
Device: Fluoridated Toothpaste
Participants will use fluoridated toothpaste (1450 ppm fluoride) three times daily under parental supervision for 9 months to compare its effects with Nano-hydroxyapatite.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
Before intervention as a baseline reading (T0), one month (T1), three months later (T2), and six months later (T3).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdulaziz University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 29, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 21, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 130-10-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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