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

Phase 2

Completed

• Conditions: Caries; Side Effect; Antimicrobial Effect; High Caries Risk Patients
• Interventions: Drug: Arabic, Gum; Drug: Licorice Root; Drug: Chlorhexidine

• Registration Number: NCT03684993
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed 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

Study Timeline

• Study First Submitted: 2018-09-24
• Study First Submitted QC: 2018-09-24
• Study First Posted: 2018-09-26
• Study Start: 2019-12-10
• Primary Completion: 2020-01-15
• Study Completion: 2020-01-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arabic gum extract	Arabic, Gum	natural product Arabic gum (acacia gum) prepared as a mouthwash
Licorice root extract	Licorice Root	natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash
Chlorhexidine	Chlorhexidine	chemical agent Chlorhexidine as a mouthwash

Primary Outcome Measures

Name	Time	Method
Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera	1 year (detected after 3, 6, 9 and 12 months)	development of new caries lesions. Clinical examination during study time to Measure DMF scoring index: any changes in number of decayed, missing and filled surfaces due to caries from baseline. Done according to International Caries Detection and Assessment System (ICDAS II criteria)

Secondary Outcome Measures

Name	Time	Method
Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL)	1 year (evaluated after 3, 6, 9 and 12 months)	Antimicrobial effect against streptococcus mutans and lactocbacilli: saliva samples collected and total bacterial count measured after agar plates incubating, expressed in colony forming units
Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no)	1 year (recorded after each month of mouthwash use)	side effects from long term use of mouthwash

Trial Locations

Locations (1)

Faculty of Dentistry Cairo University; 🇪🇬 Cairo, Egypt