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NCT03763578 Clinical Trial

Dental Caries Prevention by a Natural Product

Dental Caries Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03763578
Other study ID # 18941
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date December 30, 2021

Study information
Verified date February 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

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)

Recruitment information / eligibility
Status Completed
Enrollment 81
Est. completion date December 30, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 25 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Licorice
Natural herbal product

Locations
Country Name City State
Egypt Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University Cairo Choose Any State/Province

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of new carious lesions Appearance of new carious lesions within the study duration 12 months
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