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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-10

Study Completion Date

2020-01-15

Brief Summary

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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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Detailed Description

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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

Conditions

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High Caries Risk Patients Caries Antimicrobial Effect Side Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arabic gum extract

natural product Arabic gum (acacia gum) prepared as a mouthwash

Group Type EXPERIMENTAL

Arabic, Gum

Intervention Type 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.

Licorice root extract

natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash

Group Type EXPERIMENTAL

Licorice Root

Intervention Type 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

Chlorhexidine

chemical agent Chlorhexidine as a mouthwash

Group Type ACTIVE_COMPARATOR

Chlorhexidine

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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

Intervention Type DRUG

Chlorhexidine

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

Intervention Type DRUG

Other Intervention Names

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acacia gum Glycyrrhiza Glabra Chlorhexidine gluconate or Chlorhexidine HCL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes