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Dental Caries Prevention by a Natural Product

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT03763578
Collaborator
(none)
81
Enrollment
1
Location
3
Arms
15.9
Actual Duration (Months)
5.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: Licorice
 N/A

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

Study Type:
Interventional
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 :
Sep 1, 2020
Actual Primary Completion Date :
Dec 1, 2020
Actual Study Completion Date :
Dec 30, 2021

Arms and Interventions

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

    Primary Outcome Measures

    1. Incidence of new carious lesions [12 months]

      Appearance of new carious lesions within the study duration

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University Cairo Choose Any State/Province Egypt 002

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Mohammed Ahmed Mady, Principal Investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT03763578
    Other Study ID Numbers:
    • 18941
    First Posted:
    Dec 4, 2018
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Dental Caries

    Study Results

    No Results Posted as of Feb 8, 2022