Clinical trial NCT03684993: Caries Prevention and Side Effects of Gum Arabic and Licorice Extracts Versus Chlorhexidine in High Caries Risk Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: High Caries Risk Patients
Caries
Antimicrobial Effect
Side Effect
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility 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

Primary outcomes:
measure: Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera
timeFrame: 1 year (detected after 3, 6, 9 and 12 months)
Secondary outcomes:
measure: Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL)
timeFrame: 1 year (evaluated after 3, 6, 9 and 12 months)
measure: Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no)
timeFrame: 1 year (recorded after each month of mouthwash use)
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Cairo University
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.