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

February 26, 2020 updated by: Dina Mohamed Kamal Eldin, Cairo University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12411
        • Faculty of Dentistry Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 1 year (detected after 3, 6, 9 and 12 months)
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)
Time Frame: 1 year (evaluated after 3, 6, 9 and 12 months)
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)
Time Frame: 1 year (recorded after each month of mouthwash use)
side effects from long term use of mouthwash
1 year (recorded after each month of mouthwash use)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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