Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients
Keywords
Abstract
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
Dates
| Last Verified: | 01/31/2020 |
| First Submitted: | 09/23/2018 |
| Estimated Enrollment Submitted: | 09/23/2018 |
| First Posted: | 09/25/2018 |
| Last Update Submitted: | 02/25/2020 |
| Last Update Posted: | 02/27/2020 |
| Actual Study Start Date: | 12/09/2019 |
| Estimated Primary Completion Date: | 01/14/2020 |
| Estimated Study Completion Date: | 01/14/2020 |
Condition or disease
Intervention/treatment
Drug: Arabic gum extract
Drug: Licorice root extract
Drug: Chlorhexidine
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arabic gum extract natural product Arabic gum (acacia gum) prepared as a mouthwash | Drug: Arabic gum extract 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. |
| Experimental: Licorice root extract natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash | Drug: Licorice root extract 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 |
| Active Comparator: Chlorhexidine chemical agent Chlorhexidine as a mouthwash | Drug: Chlorhexidine chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. 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)]
Secondary Outcome Measures
1. Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL) [1 year (evaluated after 3, 6, 9 and 12 months)]
2. Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no) [1 year (recorded after each month of mouthwash use)]
