Dental Caries Prevention by a Natural Product

NCT ID: NCT03763578

Last Updated: 2022-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-30

Brief Summary

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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

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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)

Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Licorice

Intervention Type OTHER

Natural herbal product

Chlorhexidine

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

Group Type ACTIVE_COMPARATOR

Licorice

Intervention Type OTHER

Natural herbal product

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)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Licorice

Natural herbal product

Intervention Type OTHER

Other Intervention Names

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Glycyrrhiza glabra Linn Mulethi

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Sara Mohammed Ahmed Mady

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Cairo, Choose Any State/Province, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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18941

Identifier Type: -

Identifier Source: org_study_id

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