Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dental Caries Prevention by a Natural Product

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763578
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : February 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sara Mohammed Ahmed Mady, Cairo University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Licorice Not Applicable

Detailed 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)

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 81 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Licorice Versus Standard Preventive Measures for the Prevention of Caries Incidence in Young Egyptian Adults: Randomized Controlled Trial
Actual Study Start Date : September 1, 2020
Actual Primary Completion Date : December 1, 2020
Actual Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Licorice
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
Natural herbal product
Other Names:
  • Glycyrrhiza glabra Linn
  • Mulethi
Active Comparator: Chlorhexidine
The "gold standard" of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect.
 Other: Licorice
Natural herbal product
Other Names:
  • Glycyrrhiza glabra Linn
  • Mulethi
No Intervention: Control Group
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of new carious lesions [ Time Frame: 12 months ]
    Appearance of new carious lesions within the study duration


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03763578


Locations
Layout table for location information
Egypt
Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University
Cairo, Choose Any State/Province, Egypt, 002
Sponsors and Collaborators
Cairo University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sara Mohammed Ahmed Mady, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03763578    
Other Study ID Numbers: 18941
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases