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Completed

NCT Number: NCT03684993

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

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.

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Key information

Conditions

High Caries Risk Patients Antimicrobial Effect Caries Side Effect

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Faculty of Dentistry Cairo University

Cairo, 12411, Egypt

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arabic, Gum

Drug

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

Licorice Root

Drug

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

Chlorhexidine

Drug

chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard

Other names: Chlorhexidine gluconate or Chlorhexidine HCL

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2018
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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