Dental Caries Prevention by a Natural Product

Cairo University (CU)

Status: Completed

Conditions: Dental Caries

Treatments: Other: Licorice

Study type: Interventional

Funder types: Other

Identifiers

NCT03763578

18941

Details and patient eligibility

About

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.

Full 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)

Enrollment: 81 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 3 patient groups

Licorice

Experimental group

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.

Treatment:

Other: Licorice

Chlorhexidine

Active Comparator group

Description:

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

Treatment:

Other: Licorice

Control Group

No Intervention group

Description:

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)