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Dental Caries Prevention by a Natural Product

Primary Purpose

Dental Caries

Status

Completed

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

Licorice

About this trial

This is an interventional prevention trial for Dental Caries

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Licorice

Chlorhexidine

Control Group

Arm Description

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.

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

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)

Outcomes

Primary Outcome Measures

Incidence of new carious lesions

Appearance of new carious lesions within the study duration

Secondary Outcome Measures

Full Information

NCT ID

NCT03763578

First Posted

November 10, 2018

Last Updated

February 7, 2022

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03763578

Brief Title

Dental Caries Prevention by a Natural Product

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

September 1, 2020 (Actual)

Primary Completion Date

December 1, 2020 (Actual)

Study Completion Date

December 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. 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.

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Licorice

Arm Type

Experimental

Arm Description

Arm Title

Chlorhexidine

Arm Type

Active Comparator

Arm Description

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

Arm Title

Control Group

Arm Type

No Intervention

Arm Description

Intervention Type

Other

Intervention Name(s)

Licorice

Other Intervention Name(s)

Glycyrrhiza glabra Linn, Mulethi

Intervention Description

Natural herbal product

Primary Outcome Measure Information:

Title

Incidence of new carious lesions

Description

Appearance of new carious lesions within the study duration

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University

City

Cairo

State/Province

Choose Any State/Province

ZIP/Postal Code

002

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Dental Caries Prevention by a Natural Product

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