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CompletedNCT03763578Updated Feb 8, 2022

Dental Caries Prevention by a Natural Product

An interventional study of Licorice in Dental Caries, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2022-02-08.

Sponsored by Cairo University · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
81
Allocation
Randomized
Ages
18 Years to 25 Years
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • Dental Caries

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03

In context

Dental Caries

1,109 studies on the registry are indexed under Dental Caries; 197 are open to participants now.

This study's enrollment of 81 is above the median of 60 across 916 interventional studies indexed under Dental Caries.

Browse Dental Caries studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 25 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
81 participants (actual)

Study arms

  • 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

  • Active comparator
    Chlorhexidine

    The "gold standard" of oral therapeutics is Chlorhexidine due to its prolonged broad- spectrum antimicrobial effect.

    Other: Licorice

  • 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)

Interventions

  • OtherLicorice

    Natural herbal product

    Also known as: Glycyrrhiza glabra Linn, Mulethi

06

What researchers measure

Primary outcomes

  1. Incidence of new carious lesions

    Appearance of new carious lesions within the study duration

    Time frame: 12 months

07

Study locations

1 site
  • Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University
    Cairo, Choose Any State/Province 002, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03763578
Lead sponsor
Cairo University
Responsible party
Sara Mohammed Ahmed Mady (Principal Investigator, Cairo University) — Principal investigator
First posted
Dec 4, 2018
Start date
Sep 1, 2020
Primary completion
Dec 1, 2020
Completion
Dec 30, 2021
Last update
Feb 8, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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