Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients

Cairo University (CU)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Side Effect; High Caries Risk Patients; Caries; Antimicrobial Effect

Treatments: Drug: Arabic, Gum; Drug: Licorice Root; Drug: Chlorhexidine

Study type: Interventional

Funder types: Other

Identifiers

NCT03684993

arabic gum licorice CHX

Details and patient eligibility

About

This trial is to test the caries prevention effect of Arabic gum and Licorice root extracts compared to Chlorhexidine in high caries risk patients. The antimicrobial efficacy and oral side effects from using these mouthwashes will also be tested.

Full description

To evaluate the effect of Arabic gum (Acacia gum) and Licorice (Glycyrrhiza Glabra) mouthwashes in comparison to Chlorhexidine mouthwash on reducing caries incidence (development of new caries lesions), antimicrobial efficacy and the prevalence of oral side effects (adverse events) in high caries risk patients.

P: Population with high caries risk patients I1: Arabic Gum mouthwash I2: Licorice mouthwash C: Chlorhexidine mouthwash O1: (Primary outcome) incidence of new caries lesions O2: (secondary outcome) antimicrobial efficacy O3: oral side effects (adverse events) from mouthwash use

Enrollment: 63 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• High caries risk patients according to CAMBRA caries risk assessment tool
• Baseline of at least 2-3 active non-cavitated or cavitated carious lesionssz
• Baseline salivary Mutans streptococci count ≥ 106 CFU/ml
• Baseline salivary Lactobacilli count ≥ 104 CFU/ml
• Baseline DMF index of at least 3-5
• Cooperative patients approving to participate in the study

Exclusion criteria

• Any systemic conditions, severe medical complications
• Significant past or current medical condition that may affect oral health or oral flora
• Current medications (may affect the oral flora or salivary flow)
• Allergy to any of the ingredients of the study products
• Use of any antibiotics within the past 3 months
• Use of any mouth rinses within the past 3 months
• Current periodontitis (sites of probing pocket depth ≥ 5 mm)
• Evidence of parafunctional habits
• Dysfunction of temporomandibular joint
• Presence of developmental dental anomalies
• Presence of orthodontic appliance or removable prosthesis
• Pregnancy
• Xerostomia
• Heavy smoking
• Drug or alcohol addiction, or conditions that may decrease adhering to study protocol
• Lack of compliance

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 3 patient groups

Arabic gum extract

Experimental group

Description:

natural product Arabic gum (acacia gum) prepared as a mouthwash

Treatment:

Drug: Arabic, Gum

Licorice root extract

Experimental group

Description:

natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash

Treatment:

Drug: Licorice Root

Chlorhexidine

Active Comparator group

Description:

chemical agent Chlorhexidine as a mouthwash

Treatment:

Drug: Chlorhexidine