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临床试验/NCT06144034
NCT06144034已完成不适用

Effect of Air Polishing for Biofilm Removal on Clinical, Biological, and Patient-Reported Experience Among Epileptic and Non-Epileptic Children: A Split-Mouth Randomised Clinical Trial

King Abdullah University Hospital4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
4
主要终点
patient satisfaction

研究概览

简要总结

In epileptic and non Epileptic children, the full dentition of each patient was split into four quadrants, starting from the upper right quadrant (1) and moving clockwise until the lower right quadrant (4). Bundled into two groups: quadrant (1+3) vs. (2+4). After randomization, each of these pairs of quadrants had the same treatment modality; test quadrants received treatment with airflow to remove soft biofilm, and ultrasonic scaler for areas with calculus deposits, and control quadrants were treated with conventional rubber cup polishing to remove soft biofilm and ultrasonic scaler for calculus deposits.

详细描述

The treatment of each quadrant was administered sequentially, beginning with the upper right quadrant. Treatment duration was measured in seconds from the start of treatment in each quadrant until the removal of all disclosed biofilm and calculus. This process was repeated for each quadrant individually. And intra-oral photographs were taken before, immediately after treatment, and at follow-up time.

Conventional treatment was conducted after biofilm disclosure by a rubber cup and prophylaxis paste spearmint (Kemdent Works, Purton. Swindon, Wiltshire. SN5 4HT, UK). The power setting was between 70% and 100%. The rubber cup was used until all biofilm was removed, then, if present, calculus was removed by Electro Medical Systems (EMS) ultrasonic scaler with a power setting between 3-6 on the Airflow control panel.

For Airflow, treatment was conducted after biofilm disclosure. The powder chamber of the air polishing device was filled with low-abrasive erythritol powder, according to the manufacturer's instructions. The tip of the handpiece was positioned at an angle of 70° to the surface of the tooth to be polished at 3 mm from the tooth surface. Once activated, a non-stop movement from mesial to distal and distal to mesial in a smiley face shape starting from the gingival sulcus and moving upwards coronally to the incisal to cover the entire clinical crown was performed, with a power setting ranging from 3-6 on the control panel of the airflow device. EMS ultrasonic scaler was used to remove calculus if present with a power ranging from 3-6.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Outcomes Assessor was blinded to treatment intervention

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children aged 5 to 15 years with epilepsy
  • on anti-epileptic drugs (AED) for at least 3 months
  • periodontal pockets depths not exceeding 3mm
  • full-mouth plaque scores over 50%, and having 5 teeth per quadrant.
  • The non-epileptic group included healthy non-epileptic children meeting similar criteria for age, periodontal health, and plaque scores

排除标准

  • coexisting neurological illnesses other than epilepsy, medical conditions impacting oral health, periodontitis, asthma, swallowing difficulties, intellectual disabilities, and non-ambulatory status

结局指标

主要结局

patient satisfaction

时间窗: immediately after treatments of each quadrant.

Likert Faces 5-points satisfaction scale, 0-4, 0 = Very dissatisfied. 4= Very satisficed

Treatment duration

时间窗: from the time procedure begins until removing all dental biofilm and calculus

for each quadrant, time was measured from beginning of treatment till biofilm and calculus are fully removed per seconds

Pain measure

时间窗: immediately after treatments of each quadrant.

Faces pain scale-Revised 0-10, 0 no pain, 10 maximum pain

Gingival inflammation

时间窗: Before treatment began, and two weeks after treatment.

using Loe and Silness gingival index. Before biofilm disclosing, evaluated by assigning scores from 0-3 for gingival inflammation at four sites (mesial, distal, buccal, and lingual/palatal) per tooth, 0- normal gingiva and 3 - severely inflamed

Mean Marginal Plaque

时间窗: Before treatment began, immediately after, and two weeks after treatment.

O'Leary Plaque Index on 6 sites per tooth, 0= absence of plaque or 1= presence of plaque

次要结局

  • Biomarkers(Before treatment began, and two weeks after treatment.)
  • Residual plaque area(Before treatment began, immediately after, and two weeks after treatment.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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