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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03684993
Other study ID # arabic gum licorice CHX
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date December 10, 2019
Est. completion date January 15, 2020

Study information

Verified date February 2020
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

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

Study Design


Intervention

Drug:
Arabic, 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.
Licorice 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
Chlorhexidine
chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard

Locations

Country Name City State
Egypt Faculty of Dentistry Cairo University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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

Outcome

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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