ASSESSING THE EFFECTIVENESS OF BAMBOO AND PLASTIC TOOTHBRUSHES IN ENHANCING PLAQUE CONTROL AND GINGIVAL HEALTH: A RANDOMIZED CONTROLLED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Plaque Index Score (Silness and Löe Index) – Mean reduction in plaque accumulation from baseline to 2 weeks and 4 weeks.
研究概览
简要总结
Oral health is crucial for overall well-being, impacting functions like eating, speaking, and social interactions. Poor oral health is linked to systemic diseases such as cardiovascular disease, diabetes, and respiratory illnesses. Toothbrushes play a vital role in oral hygiene, but plastic toothbrushes contribute significantly to environmental pollution. With an estimated 400 million toothbrushes discarded annually in the United States alone, plastic waste poses a major ecological concern due to its non-biodegradable nature. Bamboo toothbrushes have emerged as an eco-friendly alternative, offering biodegradable handles and comparable effectiveness in plaque removal and gingival health. This randomized controlled trial (RCT) aims to compare bamboo and plastic toothbrushes in terms of plaque removal, gingival health improvement, and microbial contamination. The study will recruit 88 healthy adults (aged 18–44 years) from the Outpatient Department (OPD) of Government Dental College and Hospital, Raipur, Chhattisgarh. Participants will be randomly assigned to Group A (bamboo toothbrush) or Group B (plastic toothbrush). The study objectives include evaluating plaque removal using plaque indices, assessing gingival health through gingival indices, and analyzing microbial contamination post-use. Ethical approval will be obtained, and informed consent will be taken from participants. Previous studies indicate that bamboo toothbrushes may initially harbor more bacteria but show a significant reduction over time. This study will contribute valuable evidence on their effectiveness and hygienic conditions, guiding recommendations for sustainable oral hygiene practices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 44.00 Year(s)（—）
- 性别
- All
入选标准
- •Individuals aged between 18 and 44 years who have at least 20 natural teeth will be included in the study.
- •Participants must be willing to provide informed consent and demonstrate a commitment to complying with the study protocol.
- •They should also agree to follow the prescribed oral hygiene instructions and attend all scheduled follow-up visits as required.
排除标准
- •Individuals with systemic conditions that may affect oral health, those taking medications known to influence oral health or microbial flora such as antibiotics or corticosteroids, those undergoing orthodontic treatment or using oral appliances will be excluded from the study.
- •Pregnant or lactating women and individuals with active periodontal disease requiring treatment beyond routine oral prophylaxis will also not be eligible to participate.
结局指标
主要结局
Plaque Index Score (Silness and Löe Index) – Mean reduction in plaque accumulation from baseline to 2 weeks and 4 weeks.
时间窗: Plaque Index Score (Silness and Löe Index) – Mean reduction in plaque accumulation from baseline to 2 weeks and 4 weeks. | Gingival Index Score (Löe and Silness Index) – Mean reduction in gingival inflammation from baseline to 2 weeks and 4 weeks.
Gingival Index Score (Löe and Silness Index) – Mean reduction in gingival inflammation from baseline to 2 weeks and 4 weeks.
时间窗: Plaque Index Score (Silness and Löe Index) – Mean reduction in plaque accumulation from baseline to 2 weeks and 4 weeks. | Gingival Index Score (Löe and Silness Index) – Mean reduction in gingival inflammation from baseline to 2 weeks and 4 weeks.
次要结局
- Toothbrush Wear Assessment – Evaluation of bristle wear and deformation using a standardized wear index at 4 weeks.(Microbial Analysis – Quantitative assessment of oral microbial load (e.g., Streptococcus mutans and Lactobacillus spp.) using saliva samples at baseline, 2 weeks, 4 weeks.)
研究者
Dr Aruhi Sinha
Government Dental College & Hospital Raipur, Chhattisgarh