The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
Primary Purpose
Plaque, Dental
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
brushing
Sponsored by
About this trial
This is an interventional prevention trial for Plaque, Dental
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Salvadora persica
tooth brush
Arm Description
brush teeth with Salvadora persica "Miswak"
brush with fluoridated tooth paste
Outcomes
Primary Outcome Measures
green and vermillion
plaque level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04137393
Brief Title
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
Official Title
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Heba sabbagh
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plaque, Dental
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Salvadora persica
Arm Type
Experimental
Arm Description
brush teeth with Salvadora persica "Miswak"
Arm Title
tooth brush
Arm Type
Active Comparator
Arm Description
brush with fluoridated tooth paste
Intervention Type
Combination Product
Intervention Name(s)
brushing
Intervention Description
mechanical and chemical plaque removal
Primary Outcome Measure Information:
Title
green and vermillion
Description
plaque level
Time Frame
4 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
32054468
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
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