Dental Caries Prevention by a Natural Product

Study Overview
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Brief Summary
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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.

Detailed Description
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Research hypothesis (Null hypothesis): The present clinical trial will be conducted to reject or accept the null hypothesis that using Licorice extract mouth wash in addition to standard preventive measures will not differ from using standard preventive measures alone in preventing incidence of new carious lesions. PICOTS: P: Population with high caries risk patients I: Use of licorice. I2: Use of chlorhexidine C: Use of standard preventive measures (tooth brushing, tooth paste, interdental cleaning). O.1: Primary outcome is incidence of new carious lesions T: Time for measurement is 12 months S: A Randomized controlled clinical trial (Parallel study)

Official Title
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Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled Trial

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Licorice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with high caries risk, 18-25 years, Males or females, Medically free patients, Patients approving to participate in the study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Licorice<br>licorice 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. | Other: Licorice<br>* Natural herbal product<br>* Other names: Mulethi;|
| Active Comparator: Chlorhexidine<br>The gold standard of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect. | Other: Licorice<br>* Natural herbal product<br>* Other names: Mulethi;|
| No Intervention: Control Group<br>Participants 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) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new carious lesions | Appearance of new carious lesions within the study duration | 12 months |