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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04137393
Other study ID # 006-16
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date October 2016
Est. completion date June 2018

Study information

Verified date October 2019
Source King Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date June 2018
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender Male
Age group 8 Years to 9 Years
Eligibility Inclusion Criteria:

- Healthy children

- age from 8 to 9

- parents signed the consent form they attended morning session for brushing

Exclusion Criteria:

- medical compromised children

- parents did not sign the consent form Did not attend morning session

Study Design


Related Conditions & MeSH terms


Intervention

Combination Product:
brushing
mechanical and chemical plaque removal

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Heba sabbagh

Outcome

Type Measure Description Time frame Safety issue
Primary green and vermillion plaque level 4 months
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