NCT07409610

Brief Summary

The study investigates the effectiveness of a 45°-cut miswak for plaque removal compared to a toothbrush in children and assesses their preferences for these tools. Conducted at King Abdulaziz University Dental Hospital, it employs a split-mouth randomized controlled trial design to measure plaque levels and gather feedback through a questionnaire.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 19, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

February 13, 2026

Completed
Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

3 months

First QC Date

January 19, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

Salvadora persicaBrushing techniqueplaque removalMiswak

Outcome Measures

Primary Outcomes (1)

  • The plaque index score

    The plaque index score, a continuous measure assessed using the Simplified Oral Hygiene Index (OHI-S) developed by Greene and Vermillion (1964) (Greene and Vermillion 1964)

    At baseline and after 3 weeks

Study Arms (2)

Intervention (Miswak)

EXPERIMENTAL

This arm introduces a 45° miswak technique, which aligns with the modified Bass method by angling the miswak fibers at 45° toward the gingival margin

Other: Miswak

Control (Tooth brushing)

ACTIVE COMPARATOR

Participants in this arm used the modified bass technique using normal tooth brush and tooth paste

Other: Toothbrush

Interventions

MiswakOTHER

Miswak is a traditional oral hygiene tool made from the twigs of the Salvadora persica tree. It's used for cleaning teeth and has natural antibacterial properties. Miswak is popular in many cultures, particularly in the Middle East and parts of Africa, and is valued for its effectiveness in promoting oral health.

Also known as: Salvadora persica
Intervention (Miswak)

A toothbrush is a small, handheld device used for cleaning teeth and maintaining oral hygiene. It typically consists of a handle and a head with bristles that help remove plaque, food particles, and bacteria from the teeth and gums, often used in conjunction with toothpaste.

Control (Tooth brushing)

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children aged 6 to 14 years.
  • Children who their parents/legal guardians have approved and signed the consent form, which ensures that the participants are within the target age range and are healthy, which helps to control variables that could affect oral hygiene outcomes.

You may not qualify if:

  • Unhealthy children
  • Children whose ages are below 6 years or above 14 years
  • Children with orthodontic brackets because it can affect oral hygiene practices and outcomes, excluding these participants ensures a more homogeneous sample.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Abdulaziz university

Jeddah, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
The study used single blinding, meaning the examiners didn't know which side of the mouth was treated with Miswak or toothbrush to avoid bias in their assessments. Since the tools used (Miswak and toothbrush) looked different, it wasn't possible to blind the participants or their parents.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 13, 2026

Study Start

September 12, 2025

Primary Completion

December 12, 2025

Study Completion

January 19, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations