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

NCT07355465 | Not Yet Recruiting

• 1 other identifier: 130-10-24
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  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

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

Study Arms (2)

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.

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

Device: Fluoridated Toothpaste

Interventions

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,

Salvadora Persica (Miswak)

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.

Fluoridated Toothpaste Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King Abdulaziz University: lead

MeSH Terms

Conditions

Molar Hypomineralization

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: January 21, 2026
• Study Start: January 29, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: January 21, 2026

Record last verified: 2026-01