Miswak Versus Standard Measures to Prevent the Incidence of Caries Young Egyptian Adults: A Randomized Controlled Clinical Trial
1 other identifier
interventional
82
1 country
1
Brief Summary
Objectives: Aim of the study The objective is to conduct an RCT to evaluate the effectiveness of miswak in comparison with standard caries preventive measures for the prevention of new carious lesions in high caries risk patients.
- Research hypothesis (alternative hypothesis): This study will be designed to test the alternative hypothesis that using miswak in addition to standard preventive measures will show significant difference over using standard preventive measures alone in preventing incidence of new carious lesions in high caries risk patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
November 4, 2018
CompletedFirst Posted
Study publicly available on registry
November 6, 2018
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedFebruary 25, 2020
February 1, 2020
3 years
November 4, 2018
February 22, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of new caries lesions
visual tactil inspection
12 months
Study Arms (3)
standerd preventive measures
SHAM COMPARATORtooth brushing twice daily with fluoride tooth paste and dental flossing and mouthwash
miswak stick
EXPERIMENTALuse of miswak stick twice daily
Use of Miswak plus tooth brushing and tooth paste
EXPERIMENTALuse of miswak stick and tooth brush with fluoride toothpaste twice daily
Interventions
use of miswak stick with tooth brushing and fluoride toothpaste for oral hygiene measures
use toothbrush with fluoride toothpaste and interdental cleaning by dental flossing and use mouth wash containing chlorohexadine
Eligibility Criteria
You may qualify if:
- patients with High caries risk
- years
- Males or females
- Medically free patients
- Patients approving to participate in the study
You may not qualify if:
- Patients were on antibiotic therapy or corticosteroid therapy for 30 days before the examination
- Patients had history of professional cleaning in the last 15 days
- Patients with exposed pulp
- Evidence of parafunctional habits
- Patients with developmental dental anomalies
- Patients undergoing or will start orthodontic treatment
- Patients with removable prosthesis
- Periapical Abscess or Fistula
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
6Th of October University
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miswak versus standard measures to prevent the incidence of caries young Egyptian adults: A Randomized Controlled Clinical Trial
Study Record Dates
First Submitted
November 4, 2018
First Posted
November 6, 2018
Study Start
January 1, 2019
Primary Completion
January 1, 2022
Study Completion
March 1, 2022
Last Updated
February 25, 2020
Record last verified: 2020-02