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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arabic gum extract | Experimental | natural product Arabic gum (acacia gum) prepared as a mouthwash |
|
| Licorice root extract | Experimental | natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash |
|
| Chlorhexidine | Active Comparator | chemical agent Chlorhexidine as a mouthwash |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arabic, Gum | Drug | 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. |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry Cairo University | Cairo | 12411 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25574715 | Background | 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. | |
| 21449211 | Background | 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. |
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|
| Licorice Root | Drug | 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 |
|
|
| Chlorhexidine | Drug | chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard |
|
|
| 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) |
| 25316992 | Background | 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. |
| 27129589 | Background | Almaz ME, Sonmez IS, Okte 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. |
| 24021323 | Background | 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. |
| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| C000722286 | Glycyrrhiza glabra extract |
| D002710 | Chlorhexidine |
| C010882 | chlorhexidine gluconate |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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