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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arabic gum extract
natural product Arabic gum (acacia gum) prepared as a mouthwash
干预措施: Arabic, Gum (Drug)
Licorice root extract
natural product Licorice (Glycyrrhiza Glabra) root extract prepared as a mouthwash
干预措施: Licorice Root (Drug)
Chlorhexidine
chemical agent Chlorhexidine as a mouthwash
干预措施: Chlorhexidine (Drug)
结局指标
主要结局
Caries incidence - DMF index - visual and tactile clinical examination for caries detection according to the ICDAS critera
时间窗: 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)
次要结局
- Antimicrobial efficacy - Incubating agar plates - Colony forming units (CFU/mL)(1 year (evaluated after 3, 6, 9 and 12 months))
- Side (Adverse) effect - subjective: Reporting Questionnaire - Binary outcome (yes/no)(1 year (recorded after each month of mouthwash use))
研究者
Dina Mohamed Kamal Eldin
Assistant lecturer
Cairo University