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Trial record 32 of 1201 for:    tooth decay

Dental Caries Prevention by a Natural Product

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ClinicalTrials.gov Identifier: NCT03763578
Recruitment Status : Not yet recruiting
First Posted : December 4, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Sara Mohammed Ahmed Mady, Cairo University

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)


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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)



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



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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.

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
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Egypt
Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University Not yet recruiting
Cairo, Choose Any State/Province, Egypt, 002
Contact: Sara Mady, Masters    00201004705764    sara.mady@dentistry.cu.edu.eg   
Contact: Sara Mady, Masters    00201001181056    dr.saramady@hotmail.com   
Sponsors and Collaborators
Cairo University

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Responsible Party: Sara Mohammed Ahmed Mady, Principal Investigator, Cairo University
ClinicalTrials.gov Identifier: NCT03763578     History of Changes
Other Study ID Numbers: 18941
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants