Clinical Outcomes of Using Erythritol Powder by Means of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets in Hand of Dental Students: A Split-mouth, Randomized, Comparative, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- change in the papillary bleeding index
研究概览
简要总结
Clinical evaluation of using erythritol powder as air polishing with ultrasonic scaling and root planing in the treatment of initial periodontal pockets. This trial will be split-mouth design, in which each patient will receive traditional treatment (ultrasonic mechanical therapy and polishing) in one side, while the contralateral two quadrants of the jaws will be treated with erythritol powder by means of air polishing and ultrasonic scaling and root planing.
详细描述
The aim of the study is to evaluate the usage of erythritol powder by means of air polishing in hand of undergraduate dental students as a single way to remove biofilm and the adjunctive application of ultrasonic piezo afterward for calculus removal and root planing only in the treatment of initial periodontal pockets.
The sample size will be 15 patients. Initially, oral hygiene instructions with scaling and root planing will consist of the treatment phase. Each subject will be informed comprehensively about oral hygiene instructions using disclosing solution (such as erythrosine) and hand mirror. The participant will be shown modified bass technique and the proper usage of dental floss and appropriate interdental brushes.
The control side will be treated with supra- and subgingival ultrasonic piezo scalers then supragingival polishing with rubber cup and a special fluoride containing paste as a traditional way of removal of plaque and calculus, while the test side, will be confined to erythritol powder by means of air polishing as the only way to remove ultrasonic piezo scalers.
At the end of treatment, hand instruments may be used to ensure the smoothness 0f the teeth surfaces.
Clinical measurements will be performed at baseline and at 2 weeks, 4 and 6 weeks for the plaque index and gingival indices, whereas probing will be performed only after 6 weeks.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are in generally good health
- •Patients are from both gender and their age is between 18 to 60 years.
- •Patients have a minimum of 20 teeth
- •The patient is a non-smoker (less than 5 cigarettes per day) and non-alcoholic.
- •Female participants must not be pregnant or breastfeeding (lactation).
- •the absence of severe oral habits
- •the presence of at least one residual pocket with pocket depth >4 mm with interdental sites with a probing depth of 3 to 5 mm without furcation involvement or subgingival restorations.
- •A sign informed consent from participation and permission to use obtained data for research purposes.
排除标准
- •Allergy to glycine or chlorhexidine;
- •systemic medical conditions requiring antibiotic prophylaxis (for endocarditis prophylaxis) and anti-inflammatory drugs before dental procedures;
- •active systemic infectious disease;
- •major systemic illnesses (diabetes mellitus, cancer, immunodeficiency virus, bone metabolic diseases or disorders that compromise wound healing, radiation or immunosuppressive therapy, neutropenia, agranulocytosis, or bleeding disorders.
- •chronic high dose steroid therapy
- •Patients are undergone to radiotherapy or chemotherapy before or during the study period.
- •actively smoking more than five cigarettes per day;
- •signs of generalized severe periodontitis;
- •having received periodontal maintenance within 3 months before baseline
- •patients treated with antibiotics 6 months prior to the study
- •chronic bronchitis and asthma
- •compromised immune system
- •hypersensitivity to sugar alcohols.
- •any physical limitations or restrictions that might preclude normal oral hygiene procedures.
结局指标
主要结局
change in the papillary bleeding index
时间窗: baseline, 2-weeks, 4-weeks, 6-weeks after the treatment
Probing is performed in all four quadrants. A quadrant 1 is probed only from the oral aspect, quadrant 2 from the facial, 3 again from oral, and from the facial in quadrant 4 Grade 1-Point: 20-30 seconds after probing the mesial and distal sulci with a periodontal probe, a single bleeding point is observed. Grade 2-Line/Points: A fine line of blood or several bleeding points become visible at the gingival margin. Grade 3-Triangle: The interdental triangle becomes more or less filled with blood. Grade 4-Drops: Profuse bleeding. Immediately after probing, blood flows into the interdental area to cover portions of the tooth and/or gingiva. Calculation: Papillary bleeding index= Bleeding Number/ Number of sites measured
change in the percentage of study sites positive for bleeding on probing
时间窗: baseline, 6-weeks after the treatment
All four surfaces of all teeth are assessed with regard to whether probing elicits bleeding (+) or not (-). The severity of gingivitis is expressed as a percentage. \- no bleeding upon probing (not recorded) \+ bleeding upon probing Calculation: Bleeding on probing= Number of bleeding sites x100 / Number of sites evaluated
次要结局
- change in the full mouth Plaque Index(baseline, 2-weeks, 4-weeks, 6-weeks after the treatment)
- change in the Probing pocket depth(baseline, 6- weeks after the treatment)
- change in the Calculus index(baseline, 2-weeks, 4-weeks, 6-weeks after the treatment)
- change in the Modified Gingival Index(baseline, 2-weeks, 4-weeks, 6-weeks after the treatment)
- The change of the root sensitivity(baseline, 24- hours, 48- hours, 72-hours, 1- week, 2-weeks, 4-weeks, 6-weeks after the treatment)
研究者
Hala Albonni
Dr.
Syrian Private University