Antimicrobial Effect, Caries, High Caries Risk Patients, Side Effect
Conditions
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
Interventions
DRUGArabic, Gum
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.
DRUGLicorice Root
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
DRUGChlorhexidine
chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed