Dental Caries Prevention by a Natural Product
Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled Trial
1 other identifier
interventional
81
1 country
1
Brief Summary
The objective is to conduct an RCT to evaluate the effectiveness of Licorice in comparison to standard caries preventive measures for the prevention 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 Sep 2020
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 10, 2018
CompletedFirst Posted
Study publicly available on registry
December 4, 2018
CompletedStudy Start
First participant enrolled
September 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedFebruary 8, 2022
February 1, 2022
3 months
November 10, 2018
February 7, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of new carious lesions
Appearance of new carious lesions within the study duration
12 months
Study Arms (3)
Licorice
EXPERIMENTALlicorice is one of the natural products that is listed by the Food and Drug Administration (FDA) as GRAS (generally regarded as safe) when used as food flavoring and sweetening agent which has an antimicrobial, anti-inflammatory and antiviral activity.
Chlorhexidine
ACTIVE COMPARATORThe "gold standard" of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect.
Control Group
NO INTERVENTIONParticipants in this group will follow only the standard preventive measures which is brushing twice a day after breakfast and before bed time and daily flossing interdentally before bed time. (No Mouthwash is used)
Interventions
Natural herbal product
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 who 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)
Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University
Cairo, Choose Any State/Province, 002, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 10, 2018
First Posted
December 4, 2018
Study Start
September 1, 2020
Primary Completion
December 1, 2020
Study Completion
December 30, 2021
Last Updated
February 8, 2022
Record last verified: 2022-02