Effects of Electric and Manual Toothbrushes on Periodontal Health and Oral Microbial Flora in Children With Space Maintainers: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change in Plaque Index (PI)
研究概览
简要总结
Objectives: To evaluate and compare the effects of electric and manual toothbrushes on periodontal health parameters and salivary microbial flora in children with fixed and removable space maintainers.
Materials and methods: Sixty-eight children (30 girls, 38 boys; mean age 8.8 years) requiring fixed (n=34) or removable (n=34) space maintainers were randomly allocated to electric (n=17) or manual (n=17) toothbrush subgroups. Periodontal indices; plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD) and salivary levels of Streptococcus mutans and Lactobacillus were assessed at baseline (T0), 1 month (T1), and 3 months (T2).
详细描述
A total of 68 patients (thirty girls and thirty-eight boys), aged between 6 and 12 years (mean age 8.8), who received either fixed or removable space maintainers due to premature loss of primary molar teeth, were included in the study.
Patients were randomized into two groups based on the type of space maintainer: fixed (n = 34) or removable (n = 34). Each group was further subdivided according to the type of toothbrush used: manual or electric, resulting in four subgroups (n=17). To standardize the study population, only band-and-loop appliances were used in the fixed space maintainer group, which were cemented using a fluoride-releasing glass ionomer cement (RelyX; 3M ESPE, St. Paul, MN, USA). Removable space maintainers consisted of an acrylic base with retention elements such as Adams' clasps, C clasps, or vestibular archesPatients in the removable space maintainer group were instructed to use their appliances during the day, except while eating and sleeping, and to clean them by brushing after toothbrushing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 6-12 years who required a space maintainer due to premature loss of primary molar teeth were included if they were medically healthy; had no periodontal disease, temporomandibular disorders, bruxism, abnormal oral habits, or physical/mental disabilities affecting hand movement; were not on regular medication; had not used antibiotics within the past three months or plaque-preventive agents within the last six months; and were able to comply with scheduled follow-up visits.
排除标准
- •Patients who failed to attend follow-up appointments or developed an infection/disease requiring antibiotic therapy during the study were excluded.
研究组 & 干预措施
Group I: Fixed Space Maintainer with Manual Toothbrush
In this group, patients with fixed space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter & Gamble, USA) during study period.
干预措施: Manual toothbrush (Device)
Group II: Fixed Space Maintainer with Electric Toothbrush
In this group, patients with fixed space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter & Gamble, USA) during study period.
干预措施: Electric toothbrush (Device)
Group III: Removable Space Maintainer with Manual Toothbrush
In this group, patients with removable space maintainers used manual toothbrushes (Oral-B Cavity Defense; Procter & Gamble, USA) during study period.
干预措施: Manual toothbrush (Device)
Group IV: Removable Space Maintainer with Electric Toothbrush
In this group, patients with removable space maintainers used electric toothbrushes (Oral-B Vitality Cross Action; Procter & Gamble, USA) during study period.
干预措施: Electric toothbrush (Device)
结局指标
主要结局
Change in Plaque Index (PI)
时间窗: Baseline (T0), 1 month (T1), and 3 months (T2).
Evaluation of plaque index scores using the Modified Silness and Löe Index.
Change in Gingival Index (GI)
时间窗: Baseline (T0), 1 month (T1), and 3 months (T2)
Evaluation of gingival index scores using the Gingival Index.
Change in Bleeding on Probing (BOP)
时间窗: Baseline (T0), 1 month (T1), and 3 months (T2)
Evaluation of bleeding on probing scores using the Bleeding on Probing (bop) Index
Change in salivary Lactobacillus levels
时间窗: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in salivary Streptococcus mutans levels
时间窗: Baseline (T0), 1 month (T1), and 3 months (T2)
Change in Periodontal Pocket Depth (PPD)
时间窗: Baseline (T0), 1 month (T1), and 3 months (T2)
Evaluation of periodontal pocket depth (PPD)
次要结局
未报告次要终点
研究者
Arif Bolaca
Assist. Prof. Dr.
Pamukkale University