Dental Caries Prevention by a Natural Product

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: Licorice

• Registration Number: NCT03763578
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-11-10
• Study First Submitted QC: 2018-12-01
• Study First Posted: 2018-12-04
• Study Start: 2020-09-01
• Primary Completion: 2020-12-01
• Study Completion: 2021-12-30
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Incidence of new carious lesions	12 months	Appearance of new carious lesions within the study duration

Trial Locations

Locations (1)

Conservative and Esthetic Dentistry Department-Faculty of Dentistry- Cairo University; 🇪🇬 Cairo, Choose Any State/Province, Egypt