Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03684993
• Other study ID #: arabic gum licorice CHX
• Status: Completed
• Phase: Phase 2/Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Antimicrobial Effect
• Caries
• High Caries Risk Patients
• Side Effect

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)