Effect of Probiotic Toothpaste and Regular Toothpaste on Plaque Levels of Orthodontic - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Plaque Index Simplified
研究概览
简要总结
This study is set to determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.
It will further analyze the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.
详细描述
Probiotic toothpaste is formulated to introduce beneficial bacteria into the oral cavity, promoting a balanced microbiome and inhibiting the growth of pathogenic bacteria. Previous research suggests that probiotics can reduce plaque formation, gingival inflammation, and pathogenic bacterial load. By potentially improving the oral microbiome, probiotic toothpaste could offer a superior alternative to standard toothpaste for maintaining oral hygiene in orthodontic patients. Metal and ceramic brackets differ not only in aesthetics but also in their interaction with the oral environment. Ceramic brackets are more brittle and can be more prone to plaque accumulation due to their rougher surface compared to metal brackets. This study will determine the improvement in plaque levels utilizing Plaque Index Simplified scores in orthodontic patients using probiotic toothpaste and regular toothpaste.
It will further determine the mean difference in oral hygiene scores between metal and ceramic brackets in regular toothpaste and probiotic toothpaste groups.
Plaque will be assessed using plaque disclosing tablets before the bonding (T1) and 3 weeks after the bonding (T2). The data will be collected on Plaque Index Simplified chart. Eligible participants will be randomly allocated to one of the two groups.
Group A (Control): Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A standard toothpaste and brushing technique will be conveyed to all the participants.
Group B (Intervention): Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and brushing technique will be conveyed to all the participants.
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
- None
盲法说明
For reexamination at T1, the investigators were blinded to the intervention.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will be initiating their orthodontic treatment by bonding of metal or ceramic brackets
- •Patients age between 18 - 50 years
- •Patients without any mental and physical disability or craniofacial disorders
- •Patients without enamel or dentin dysplasia
- •Patients not taking medications affecting plaque accumulation such as antibiotics or antibacterial mouth rinses
- •Patients without periodontal disease or dental caries at the study onset
- •Patients willing to follow-up after 3 weeks
排除标准
- •Patients with neurological mental deficits or otherwise medically compromised
- •Patients with past history of dental trauma or craniofacial syndromes
- •Patients who are smokers
- •Those patients who are already continuing their orthodontic treatment
- •Patients with poor oral hygiene
研究组 & 干预措施
Colgate Maximum Cavity Protection (Control)
Participants will be advised to use regular toothpaste twice a day for 3 weeks after the bonding. A regular toothpaste and a standard brushing technique will be conveyed to all the participants.
Probiotic Toothpaste Group
Participants will be advised to use a Probiotic toothpaste twice a day for 3 weeks after the bonding. A probiotic toothpaste and a standard brushing technique will be conveyed to all the participants.
干预措施: Probiotic Toothpaste (Other)
结局指标
主要结局
Plaque Index Simplified
时间窗: Before and three weeks after bonding
Number of sites with plaque/ Number of sites evaluated x 100
Gingival Index
时间窗: Before and three weeks after bonding
Gingival Index measures gingival condition of the marginal and interproximal tissues (mesial, lingual, distal, facial) separately on the basis of 0 to 3 with 0=Normal gingiva; 1= Mild inflammation - slight change in color and slight edema but no bleeding on probing; 2= Moderate inflammation - redness, edema and glazing, bleeding on probing; 3= Severe inflammation - marked redness and edema, ulceration with tendency to spontaneous bleeding.
次要结局
未报告次要终点
研究者
Kanza Tahir
Dr. Kanza Tahir
Aga Khan University