Caries Clinical Trial
Official title:
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
Verified date | February 2020 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 63 |
Est. completion date | January 15, 2020 |
Est. primary completion date | January 15, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Almaz ME, Sönmez IS, Ökte Z, Oba AA. Efficacy of a sugar-free herbal lollipop for reducing salivary Streptococcus mutans levels: a randomized controlled trial. Clin Oral Investig. 2017 Apr;21(3):839-845. doi: 10.1007/s00784-016-1827-y. Epub 2016 Apr 30. — View Citation
Chandra Shekar BR, Nagarajappa R, Singh R, Thaku R. Antimicrobial efficacy of the combinations of Acacia nilotica, Murraya koenigii L. sprengel, Eucalyptus hybrid and Psidium guajava on primary plaque colonizers. J Basic Clin Pharm. 2014 Sep;5(4):115-9. doi: 10.4103/0976-0105.141954. — View Citation
Gupta D, Gupta RK. Investigation of antibacterial efficacy of Acacia nilotica against salivary mutans streptococci: a randomized control trial. Gen Dent. 2015 Jan-Feb;63(1):23-7. — View Citation
Hu CH, He J, Eckert R, Wu XY, Li LN, Tian Y, Lux R, Shuffer JA, Gelman F, Mentes J, Spackman S, Bauer J, Anderson MH, Shi WY. Development and evaluation of a safe and effective sugar-free herbal lollipop that kills cavity-causing bacteria. Int J Oral Sci. 2011 Jan;3(1):13-20. doi: 10.4248/IJOS11005. — View Citation
Jain E, Pandey RK, Khanna R. Liquorice root extracts as potent cariostatic agents in pediatric practice. J Indian Soc Pedod Prev Dent. 2013 Jul-Sep;31(3):146-52. doi: 10.4103/0970-4388.117964. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) |
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