Effectiveness of Different Methods of Interdental Space Hygiene in Daily Practice Among Young Adults: A Randomized, Single-Blind Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Interdental bleeding at month 3 (in percentage)
研究概览
简要总结
Oral health is essential for overall well-being and systemic health. A key factor in preserving this health is maintaining the balance of the interdental microbiota, which involves regulating the quantity of pathogenic bacteria in interdental spaces (IS). These IS represent a unique ecological niche where the body has limited specific defense mechanisms, making them vulnerable to infections.
In adults, the colonization of interdental spaces by pathogenic bacteria increases the risk of periodontal diseases, which are themselves associated with non-communicable diseases such as cardiovascular diseases, diabetes, and certain types of cancer.
Preventing interdental microbiota dysbiosis from a young age is therefore a priority to maintain quality oral health and contribute to good systemic health throughout life. However, conventional brushing techniques cover only accessible tooth surfaces and cannot reach the interdental spaces. Currently, the use of interdental brushes (IDBs) is recognized as the most effective method for interdental hygiene. There are various types of IDBs, differing in several aspects that influence their effectiveness and usability. The main differences relate to their shape, size, and calibration using an interdental probe or not, allowing adaptation to different interdental space sizes. To date, only one study has demonstrated the effectiveness of daily calibrated interdental brush use in reducing dysbiosis and interdental inflammation among young adults. However, no research has yet been conducted to compare the effectiveness of the various types of IDBs available on the market (calibrated versus non-calibrated).
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
- Single (Participant)
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
- •Person between 18 and 30 years old
- •Person who has given free, informed, express written consent
- •Person affiliated to a French social security system
- •Person living or working in Lyon or the Lyon conurbation served by public transport (TCL)
排除标准
- •Person with a smoking addiction
- •Person participating in another study related to oral hygiene
- •Patients at high risk of infective endocarditis
- •Person with chronic pathologies
- •Person having taken antibiotic treatment during the month preceding the start of the study
- •Pregnant, parturient or breastfeeding woman
- •Persons deprived of liberty by a judicial or administrative decision
- •People receiving psychiatric care
- •Persons admitted to a health or social establishment for purposes other than research
- •Adults subject to a legal protection measure (guardianship, curatorship)
- •Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- •Person with fewer than 20 natural teeth
- •Person performing interdental hygiene and/or daily mouthwashes.
- •Person wearing orthodontic appliance
- •Person with periodontal disease (stage ≥ II periodontal lesions according to the Chicago 2017 classification (i.e. PD ≥ 4 mm, and/or CAL ≥ 4 mm) and/or generalized (>30% of sites )), active caries or during dental care
研究组 & 干预措施
Calibrated interdental brush
Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a calibrated interdental brushes .
干预措施: Calibrated interdental brush (Procedure)
Non-calibrated interdental brush
Healthy adult volunteers (not suffering from chronic pathologies) and non-smokers, agreeing to change their interdental hygiene habits for 3 months by daily using a non-calibrated interdental brushes .
结局指标
主要结局
Interdental bleeding at month 3 (in percentage)
时间窗: Baseline (T0), 3 months after baseline (T3)
Comparison of interdental inflammation (interdental bleeding) following the daily use of calibrated versus non-calibrated interdental brushes at month 3 (T3, expressed as a percentage and assessed at four sites per tooth following probing with a periodontal probe).
次要结局
- Composition of the Interdental microbiome (diversity and total bacteria count)(Baseline (T0))
- Periodontal health analysis(Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3))
- Periodontal health analysis - salivary pH(Baseline (T0), 1 week later (T1), 1 month after baseline (T2), 3 months after baseline (T3))
- Interdental microbiota at T3 (diversity and total bacteria count)(Baseline (T0), 3 months after baseline (T3))
- Daily use acceptability of interdental brushes(1 week after baseline (T1), 1 month after baseline (T2), 3 months after baseline (T3))