Evaluation Of Nonsurgical Treatment Of Deep Periodontal Pockets (7-10mm) Using AIRFLOW® Prophylaxis Master Device With Erythritol Powder vs Conventional Instrumentation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Change in probing pocket depth
研究概览
简要总结
Periodontitis is a chronic condition associated with the inflammatory destruction of the periodontal tissues ultimately leading to tooth loss. Clinically, it is identified by key features such as clinical attachment loss (CAL), bleeding upon probing (BOP), and an increase in probing pocket depth (PPD), and/or gingival recession. Periodontitis is mediated by polymicrobial dysbiosis with keystone pathogens affecting the virulence of the entire biofilm community. The removal of this biofilm and its retention factors is the ultimate goal of clinical treatment and oral measures applied. The elimination of the biofilm has traditionally been achieved with the use of either hand instruments or power driven devices. Promoting periodontal health or diminishing bacterial presence and calculus buildup on teeth can be accomplished with the same efficacy whether using manual scalers and curettes or ultrasonic scaling instruments. Both hand and ultrasonic instruments are characterized by being time- consuming and requiring technical skill, often causing patient discomfort and post-treatment pain, including hypersensitivity resulting from the loss of hard tissue when scaling the tooth surface. Ultrasonic instruments tend to leave a rougher surface behind compared to hand instruments. While effective the current techniques all have their disadvantages. The aim of this study is to evaluate changes in probing depth clinically, Bleeding on probing, Clinical attachment level, Plaque index, Calculus index, Patient pain/discomfort, Patient satisfaction, Cost effectiveness, Treatment time and Number of pockets closed after using AIRFLOW® Prophylaxis Master device with erythritol powder.
详细描述
Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry-Cairo University
- Screening of patients will continue until the target sample is achieved. (Consecutive sampling)
- Identifying and recruiting potential subjects will be achieved through patient database.
Preoperative evaluation:
- Clinical examination Each patient will be examined to confirm that he/she met the eligibility criteria.
Age, gender and smoking status will be collected at baseline, along with a complete periodontal charting including 6-point pocket probing depth (PPD), clinical attachment level (CAL), plaque index (PI) according to a modified O'Leary index (O'Leary et al. 1972) measured on 6 surfaces per tooth (distobuccal, buccal, mesiobuccal, distolingual, lingual and mesiolingual), Calculus index according to (Ramfjord SP. 1967).
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)
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy patients.
- •Patients with an age range between 16 to 80 years.
- •Patients have a minimum of 20 teeth.
- •Periodontitis patients with at least one residual pocket with a probing depth ranging from 7 to 10 mm.
- •Cooperative patients able and willing to come for follow up appointments.
排除标准
- •Pregnant and lactation females.
- •Patients reporting systemic conditions (eg: diabetes).
- •Patients with severe or unstable upper respiratory tract infections, chronic bronchitis/asthma.
- •Patients with severe inflammation and/or osteonecrosis.
结局指标
主要结局
Change in probing pocket depth
时间窗: PPD will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.
The PPD will be clinically measured by using UNC 15 periodontal probe from the gingival margin to the depth of the pocket.
次要结局
- Patient pain/discomfort(Postoperative Pain will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention)
- Patient satisfaction(Patient satisfaction will be measured after the surgical procedure and 1 month, 3 months and 6 months after the intervention)
- Plaque index(PI will be measured baseline, 1 month, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner)
- Calculus index(CI will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Clinical Attachment Level(CAL gain will be taken at baseline, 3 months and 6 months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Cost effectiveness(At Baseline and 6 months post-op)
- Bleeding On Probing(BoP will be taken at baseline, 1 month, 3 months and 6months after the intervention during the follow-up period and will be done by a single calibrated examiner.)
- Treatment time(Up to 6 months)
- Number of healed pockets(6 months post-op)
研究者
Mohammad Alaa Mahmoud Aldawod
Principal Investigator Mohammad Aldawod
Cairo University