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

Study Overview
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Brief Summary
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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
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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

Official Title
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Effect of Gum Arabic (Acacia Gum) and Licorice (Glycyrrhiza Glabra) Mouthwashes Compared to Chlorhexidine Mouthwash on Caries Prevention and the Prevalence of Oral Side Effects in High Caries Risk Patients: A Randomized Controlled Clinical Trial

Conditions
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High Caries Risk Patients, Caries, Antimicrobial Effect, Side Effect

Intervention / Treatment
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* Drug: Arabic, Gum
* Drug: Licorice Root
* Drug: Chlorhexidine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arabic gum extract<br>natural product Arabic gum (acacia gum) prepared as a mouthwash | Drug: Arabic, Gum<br>* natural gum of acacia tree: Antimicrobial, anti-inflammatory medicinal plant used as a traditional oral hygiene substance (anticariogenic). It is used in treating sore throats, colds, bronchitis, toothache, gingival bleeding and mouth ulcers.<br>* Other names: acacia gum;|
| Experimental: Licorice root extract<br>natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash | Drug: Licorice Root<br>* natural licorice, herbal plant to relieve coughs, sore throats, and gastric inflammation. flavouring and sweetening agent. it's anti-caries, soothing anti-inflammatory and anticancer properties benefit against oral diseases and dental caries<br>* Other names: Glycyrrhiza Glabra;|
| Active Comparator: Chlorhexidine<br>chemical agent Chlorhexidine as a mouthwash | Drug: Chlorhexidine<br>* chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard<br>* Other names: Chlorhexidine gluconate or Chlorhexidine HCL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera | 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) | 1 year (detected after 3, 6, 9 and 12 months) | 

Secondary Outcome Measures

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