The Antiplaque and Antigingivitis Effect of Pure Green Tea Mouth Wash Compared to Placebo and Essential Oils Mouth Washes: A Double Blinded Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Turesky modification of the Quigley-Hein plaque index (TM-QHPI)
研究概览
简要总结
The goal of this clinical trial is to to evaluate the antiplaque and antigingivitis effect of pure green tea mouthwash compared to placebo and essential oils mouthwashes in healthy patients.
The main questions it aims to answer are:
- Does pure green tea mouthwash effectively reduce dental plaque?
- Does pure green tea mouthwash reduce gingival inflammation?
Researchers will compare pure green tea mouthwash to Listerine Total Care, Listerine Green Tea, and placebo to see if there is a difference in plaque accumulation and gum inflammation reduction.
Participants will be prohibited from using any sort of oral hygiene parctice for the whole study period (3 weeks). Instead, they will rinse with 10 ml of their assigned mouthwash twice daily for 30 seconds. Plaque index, gingival index, and staining index will be examined at multiple intervals and participants will rate their sense of oral freshness and good breath.
详细描述
• Study Design
This study will be a double-blinded, randomized, controlled, clinical trial with a parallel group design. Participants will be randomly allocated into four groups:
Group P: placebo (pure water with a flavored additive) solution. Group T1: pure green tea mouthwash. Group T2: Listerine Total Care mouthwash. Group T3: Listerine Green Tea mouthwash.
All participants will be instructed to rinse with 10 ml of the assigned mouthwash for 30 seconds twice daily over a three-week experimental period. The study will follow the experimental gingivitis model, during which participants will refrain from all forms of mechanical plaque control.
- Sample Size A total of 44 dental participants, aged between 18-50 years, will be recruited. Each group will consist of 11 participants, providing a power of 80% to detect a difference of 0.2 in mean plaque index values between groups, with a p-value < 0.05 and a β-error of 20%.
- Ethical Considerations All participants will be informed about the study objectives, methodology, and possible risks. Written informed consent will be obtained before participation. All procedures will follow ethical standards and the principles of the Declaration of Helsinki.
- Data Collection and Clinical Assessments Clinical examinations will be performed at baseline (T0), day 7 (T1), day 14 (T2), and day 21 (T3). The following parameters will be recorded: plaque index, gingival index, staining index, and patients reported outcome in regards to their perciption of freshness and good breath.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Participants, investigators, and outcome assessors will be blinded. Mouthwashs will be emptied in opaque bottles. They will be coded and unlabeled. A trained dental assisstant will be responsable about disposing the assigned mouth wash to the patient.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-smokers
- •Systemically healthy
- •At least 24 teeth in the functional dentition, excluding third molars
- •Clinical diagnosis of periodontal health (no periodontal pockets > 3 mm, bleeding on probing percentage < 10%, and no attachment loss).
排除标准
- •Medically compromised patients.
- •Pregnant woman.
- •Allergies to green tea or EO.
- •Any condition that might affect the periodontal tissues.
- •Patients with any carious lesions (initial or active).
- •Patients who have overhang restorations, poorly designed crowns or bridges, and ortho retainers.
- •Use of systemic antibiotics or anti-inflammatory medications within 3 months prior to enrolment.
研究组 & 干预措施
Pure Green Tea Mouthwash
Participants in this group will use a mouthwash prepared from pure green tea extract. The solution will be brewed by infusing 1 g of green tea leaves in 100 ml of boiling deionized water for 20 minutes, cooled, filtered, and stored in brown glass bottles.
干预措施: Pure Green Tea Mouthwash (Drug)
Listerine Total Care Mouthwash
Participants in this group will use Listerine Total Care essential oils mouthwash, containing eucalyptol, menthol, methyl salicylate, and thymol.
干预措施: Listerine Total Care Mouthwash (Drug)
Listerine Green Tea Mouthwash
Participants will use Listerine Green Tea mouthwash, an essential oil-based product enhanced with green tea extract.
干预措施: Listerine Green Tea Mouthwash (Drug)
Placebo Mouthwash
The solution contains only water and additive flavor with no active anti-inflammatory ingredients.
干预措施: Placebo Mouthwash (Other)
结局指标
主要结局
Turesky modification of the Quigley-Hein plaque index (TM-QHPI)
时间窗: On days 0, 7, 14, and 21
will be recorded at six aspects on each tooth (mesialbuccal, midbuccal, distobuccal, mesiolingual, midlingual, and distolingual). 0: No plaque. 1. Separate flecks of plaque at the gumline (cervical margin). 2. A thin, continuous band (up to 1 mm) at the gumline. 3. A band wider than 1 mm but covering less than one-third of the tooth crown. 4. Plaque covering one-third to two-thirds of the crown. 5. Plaque covering two-thirds or more of the crown.
次要结局
- Gingival Index (GI)(On days 0, 7, 14, and 21)
- The Discoloration Index (DI)(On days 0, 7, 14, and 21)
- Patient-reported outcome(On days 7, 14, and 21)
研究者
Lana Bader
Dr, Assistant Professor
Jordan University of Science and Technology