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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03684993
Recruitment Status : Completed
First Posted : September 26, 2018
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Dina Mohamed Kamal Eldin, Cairo University

Brief 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.

Condition or disease Intervention/treatment Phase
High Caries Risk Patients Caries Antimicrobial Effect Side Effect Drug: Arabic, Gum Drug: Licorice Root Drug: Chlorhexidine Phase 2 Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 10, 2019
Actual Primary Completion Date : January 15, 2020
Actual Study Completion Date : January 15, 2020


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 Name: 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 Name: 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 Name: Chlorhexidine gluconate or Chlorhexidine HCL




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03684993


Locations
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Egypt
Faculty of Dentistry Cairo University
Cairo, Egypt, 12411
Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Dina Mohamed Kamal Eldin, Assistant lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03684993    
Other Study ID Numbers: arabic gum licorice CHX
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents