Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07355465

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

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Molar Incisor Hypomineralisation Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dental Enamel Hypomineralization Developmental Defects of Enamel Molar Hypomineralization Stomatognathic Diseases Stomatognathic System Abnormalities Tooth Abnormalities Tooth Diseases

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 Toothpaste

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 21, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.