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

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

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.

Study Overview

• Status: Completed
• Conditions: Caries; Side Effect; High Caries Risk Patients; Antimicrobial Effect
• Intervention / Treatment: Drug: Arabic, Gum; Drug: Licorice Root; Drug: Chlorhexidine

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

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 12411
    • Faculty of Dentistry cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arabic gum extract; natural product Arabic gum (acacia gum) prepared as a mouthwash	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.; Other Names: acacia gum
Experimental: Licorice root extract; natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash	Drug: 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; Other Names: Glycyrrhiza Glabra
Active Comparator: Chlorhexidine; chemical agent Chlorhexidine as a mouthwash	Drug: Chlorhexidine; chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard; Other Names: Chlorhexidine gluconate or Chlorhexidine HCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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)
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)

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2019
• Primary Completion (Actual): January 15, 2020
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: September 24, 2018
• First Submitted That Met QC Criteria: September 24, 2018
• First Posted (Actual): September 26, 2018

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents, Local; Anti-Infective Agents; Dermatologic Agents; Disinfectants; Chlorhexidine; Chlorhexidine gluconate
• Other Study ID Numbers: arabic gum licorice CHX

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No