Comparing the Efficacy of Toothbrushing With and Without Interproximal Cleaning Aids Among Dental Students: A Split-Mouth Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Quadrant Plaque Score (QPS)
研究概览
简要总结
The goal of this prospective clinical trial is to evaluate whether adding interproximal cleaning aids (interproximal brush, rubber toothpick, water flosser) to regular tooth brushing improves oral hygiene outcomes and gingival health compared with tooth brushing alone in dental students with gingivitis and intact interdental papillae. The main questions it aims to answer are:
- Does the addition of interproximal cleaning aids to tooth brushing result in greater reduction of dental plaque accumulation compared with tooth brushing alone?
- Does the use of interproximal cleaning aids improve gingival bleeding outcomes compared with tooth brushing alone?
- Does the use of interproximal cleaning aids affect interdental papilla health and cause soft tissue trauma or damage?
- Do different interproximal cleaning aids influence participants' motivation and adherence to oral hygiene practices?
Researchers will compare tooth brushing alone with tooth brushing combined with three different interproximal cleaning aids (interdental brush, water flosser, and rubber toothpick) to determine whether these adjunctive methods provide additional benefits in plaque control, gingival health, preservation of interdental soft tissues, and participant motivation.
Participants will:
- Perform standardized tooth brushing using the modified Bass technique twice daily.
- Use the assigned interproximal cleaning aid (interdental brush, water flosser, or rubber toothpick) in designated quadrants according to standardized instructions.
- Attend clinical evaluations at baseline and after 7, 14, and 28 days.
- Undergo assessment of dental plaque score, gingival bleeding score, interdental papilla condition, and motivation related to oral hygiene practices.
详细描述
This prospective split-mouth clinical trial aims to evaluate the effectiveness and safety of different interproximal cleaning aids used in addition to toothbrushing compared with toothbrushing alone in dental students diagnosed with gingivitis and presenting with intact interdental papillae.
The study will investigate whether toothbrushing alone, when performed using a standardized and effective technique, is sufficient for maintaining plaque control and gingival health, or whether the addition of interproximal cleaning devices provides further clinical benefits. The study will also assess the potential impact of these devices on interdental papilla integrity, possible soft tissue trauma, and participant motivation and adherence.
Participants will be dental students enrolled at Saint Joseph University of Beirut who meet the eligibility criteria. Eligible participants will present with gingivitis, intact interdental papillae, and no periodontal attachment loss or conditions that may interfere with periodontal health assessment. Participants with orthodontic appliances, crowns, implants, dentures, periodontitis, diastemas, systemic conditions affecting periodontal health, or medications causing gingival enlargement will be excluded.
Each participant's mouth will be divided into four quadrants in a split-mouth design. A computer-generated randomization sequence will determine the starting position of the assigned interventions to minimize site-related bias. Each quadrant will receive one of the following oral hygiene protocols:
- Quadrant 1: Toothbrushing alone (control).
- Quadrant 2: Toothbrushing combined with an interproximal brush (IPB).
- Quadrant 3: Toothbrushing combined with a water flosser (WF).
- Quadrant 4: Toothbrushing combined with a rubber toothpick (RT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 23 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4th & 5th year dental students enrolled at Saint Joseph University of Beirut.
- •Participants clinically diagnosed with gingivitis exhibiting fully intact interdental papillae.
- •Participants who had undergone a dental cleaning session 6 weeks before inclusion in the study.
- •Written informed consent provided and signed before participation.
排除标准
- •Participants with fixed or removable orthodontic appliances, crowns, dental implants, or dentures.
- •Participants diagnosed with periodontitis.
- •Participants with reduced or absent interdental papillae.
- •Individuals with poor oral hygiene practices, including irregular or inadequate toothbrushing.
- •Participants currently taking medications known to induce gingival hyperplasia or hypertrophy.
- •Presence of diastemas or open contacts between adjacent teeth in the areas to be assessed.
- •Individuals with systemic diseases or medical conditions that may affect gingival or periodontal health.
研究组 & 干预措施
Tooth Brushing + Interproximal Brush (IPB)
Participants used an interproximal brush as an adjunct to standardized tooth brushing. The interproximal brush was inserted into interdental spaces and moved back and forth five times per site, in addition to twice-daily Modified Bass tooth brushing
干预措施: Interproximal Brush (Device)
Tooth Brushing + Water Flosser (WF)
Participants used a water flosser as an adjunct to standardized tooth brushing. The device was applied along the gingival margin using the continuous soft mode, in addition to twice-daily Modified Bass tooth brushing.
干预措施: Water flosser (Device)
Tooth Brushing + Rubber Toothpick (RT)
Participants used a rubber toothpick as an adjunct to standardized tooth brushing. The rubber toothpick was used for interdental cleaning according to the manufacturer's instructions, in addition to twice-daily Modified Bass tooth brushing.
干预措施: Rubber Toothpick (Device)
Tooth Brushing Alone (Control)
Participants received standardized tooth brushing instructions using the Modified Bass technique twice daily after the last meal. No additional interproximal cleaning aid was used. This arm served as the control group for comparison with adjunctive interproximal cleaning interventions.
干预措施: Tooth Brushing Alone (Control) (Behavioral)
结局指标
主要结局
Quadrant Plaque Score (QPS)
时间窗: Baseline (T0), Day 7, Day 14, and Day 28.
The effectiveness of each oral hygiene intervention in reducing dental plaque accumulation will be assessed using the Quadrant Plaque Score (QPS), derived from the Full-Mouth Plaque Score (FMPS) method. Plaque levels will be recorded at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention. The change in QPS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
Quadrant Bleeding Score (QBS)
时间窗: Baseline (T0), Day 7, Day 14, and Day 28.
The effect of each oral hygiene intervention on gingival inflammation will be assessed using the Quadrant Bleeding Score (QBS), derived from the Full-Mouth Bleeding Score (FMBS) method. Gingival bleeding will be recorded following periodontal probing at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention. Changes in QBS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
Quadrant Plaque Score
时间窗: Baseline (T0), Day 7, Day 14, and Day 28.
The effectiveness of each oral hygiene intervention in reducing dental plaque accumulation will be assessed using the Quadrant Plaque Score (QPS), derived from the Full-Mouth Plaque Score (FMPS; O'Leary Plaque Index). The QPS is expressed as the percentage of tooth surfaces with visible dental plaque within each quadrant, with scores ranging from 0% to 100%. Higher scores indicate greater plaque accumulation (worse oral hygiene), whereas lower scores indicate less plaque accumulation (better oral hygiene). Plaque levels will be recorded at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28). Changes in QPS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
Quadrant Bleeding Score
时间窗: Baseline (T0), Day 7, Day 14, and Day 28.
he effect of each oral hygiene intervention on gingival inflammation will be assessed using the Quadrant Bleeding Score (QBS), derived from the Full-Mouth Bleeding Score (FMBS). The QBS is expressed as the percentage of periodontal sites exhibiting bleeding on probing within each quadrant, with scores ranging from 0% to 100%. Higher scores indicate greater gingival inflammation (worse gingival health), whereas lower scores indicate less gingival inflammation (better gingival health). Gingival bleeding will be recorded following periodontal probing at baseline (T0), 7 days (T7), 14 days (T14), and 28 days (T28) after the intervention. Changes in QBS over time will be compared between tooth brushing alone and tooth brushing combined with interproximal cleaning aids (interproximal brush, water flosser, and rubber toothpick).
次要结局
- Papilla Harm (PH) Score(Baseline (T0), Day 7, Day 14, and Day 28.)
- Motivation Score(Day 7, Day 14, and Day 28.)
- Papilla Harm Score(Baseline (T0), Day 7, Day 14, and Day 28.)