NCT04137393

Brief Summary

Objectives: to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children. Methods: A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2016

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2019

Completed
Last Updated

October 24, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

October 22, 2019

Last Update Submit

October 22, 2019

Conditions

Plaque, Dental

Outcome Measures

Primary Outcomes (1)

  • green and vermillion

    plaque level

    4 months

Study Arms (2)

Salvadora persica

EXPERIMENTAL

brush teeth with Salvadora persica "Miswak"

Combination Product: brushing

tooth brush

ACTIVE COMPARATOR

brush with fluoridated tooth paste

Combination Product: brushing

Interventions

brushingCOMBINATION_PRODUCT

mechanical and chemical plaque removal

Salvadora persicatooth brush

Eligibility Criteria

Age8 Years - 9 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children
  • age from 8 to 9
  • parents signed the consent form they attended morning session for brushing

You may not qualify if:

  • medical compromised children
  • parents did not sign the consent form Did not attend morning session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Sabbagh HJ, AlGhamdi KS, Mujalled HT, Bagher SM. The effect of brushing with Salvadora persica (miswak) sticks on salivary Streptococcus mutans and plaque levels in children: a clinical trial. BMC Complement Med Ther. 2020 Feb 13;20(1):53. doi: 10.1186/s12906-020-2847-3.

    PMID: 32054468DERIVED

MeSH Terms

Conditions

Dental Plaque

Interventions

Toothbrushing

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral HygienePreventive DentistryDentistry

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 24, 2019

Study Start

October 1, 2016

Primary Completion

October 1, 2017

Study Completion

June 1, 2018

Last Updated

October 24, 2019

Record last verified: 2019-10