Guided Biofilm Therapy for Periodontal Patients Using Two Different Devices: a Split-mouth Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in BOP - Bleeding on Probing (percentage)
研究概览
简要总结
Periodontal patients will be treated with Guided Biofilm Therapy. At the baseline (T0), the following clinical indices will be collected: BoP, BS, CAL, PPD. A plaque disclosing agents will be used to instruct the patients to proper oral hygiene procedures. At this stage, using a split-mouth design, quadrants will be randomized to:
- Airflow and Scaling and calculus removal with EMS Prophylaxis Master handpiece
- Airflow and calculus removal with Mectron Combi handpiece
Patients will be visited after 1 month (T1) and 2 months (T2), in which the periodontal indexes will be collected again.
After all the procedures, VAS for pain will be assessed, with Schiff Air Index, comfort (patients), comfort (operator), timing for the procedures (minutes), satisfaction questionnaire (for patients and for the operator), consumption of the powders for the two handpiece.
详细描述
Periodontal patients that respond to the inclusion criteria and agree to participate in the study will be treated with Guided Biofilm Therapy.
At the baseline (T0), the following clinical indices will be collected: BoP, BS, CAL, PPD. A plaque disclosing agents will be used to instruct the patients to proper oral hygiene procedures. At this stage, using a split-mouth design, quadrants will be randomized to:
- Airflow and calculus removal with EMS Prophylaxis Master handpiece
- Airflow and calculus removal with Mectron Combi handpiece
Patients will be visited after 1 month (T1) and 2 months (T2), in which the periodontal indexes will be collected again.
Together with periodontal assessment, VAS for pain will be assessed, with Schiff Air Index, comfort (patients), comfort (operator), timing for the procedures (minutes), satisfaction questionnaire (for patients and for the operator), consumption of the powders for the two handpieces.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •professional dental hygiene performed at least 6 months before enrollment
- •periodontal disease: grading A or B and staging I-III
排除标准
- •neurologic, psychiatric and mental diseases
- •patients taking antibiotics during the study
- •pregnant and breastfeeding women
- •patients undergoing anticancer treatment
- •patients undergoing anticancer therapy
研究组 & 干预措施
Group A
Half of patients will be included in this group according to the split-mouth design.
干预措施: Split-mouth administration for group A (Other)
Group B
Half of patients will be included in this group according to the split-mouth design.
干预措施: Split-mouth administration for group B (Other)
结局指标
主要结局
Change in BOP - Bleeding on Probing (percentage)
时间窗: Baseline, after 30 and 60 days
Site-specific assessment of the presence or absence of gum bleeding after the insertion of the periodontal probe for the detection of PPD, detected on 4 sites (mesial, distal, vestibular, palatal/lingual).
Change in Bleeding Score (BS - Mombelli et al.)
时间窗: Baseline, after 30 and 60 days
Scoring criteria: 0: no bleeding 1. isolated visible spots 2. blood forms a confluent red line on the mucosal margin 3. profuse and copious bleeding
Change in CAL - Clinical Attachment Loss
时间窗: Baseline, after 30 and 60 days
Measurement (in mm) of the position of the gingival margin in relation to the cemento-enamel junction (CEJ).
Total time of usage
时间窗: Baseline
Total time of usage of the two handpieces.
Satisfactory questionnaire for operator
时间窗: Baseline
Comfort (from 0 to 10) Timing (from 0 to 10)
Comfort for the operator
时间窗: Baseline
Evaluation of the comfort of the operator from 0 to 10 during professional procedures.
Satisfactory questionnaire for patients
时间窗: Baseline
Choice of a score from 0 to 10 for all the following questions: * Is the time for the procedures appropriate? * Is the quantity of droplets adequate? * Dental sensitivity * Pain with the first instrument * Pain with the second instrument * General pain
Change in Probing Pocket Depth (PPD)
时间窗: Baseline, after 30 and 60 days
Evaluation (in mm) of the depth of the gingival sulcus, through a millimeter periodontal probe; it is detected from the gingival margin to the bottom of the gingival sulcus or periodontal pocket, evaluated at 6 sites.
Change in Schiff Air Index - Dental sensitivity test
时间窗: Baseline, after 30 and 60 days
Scoring criteria: 0\. the subject did not respond to air blasting; 1. the subject responded to air blasting; 2. the subject responded to air blasting and requested discontinuation; 3. the subject responded to air blasting, requested discontinuation and considered the stimulus to be painful.
次要结局
未报告次要终点
研究者
Andrea Scribante
Associate Professor, Principal Investigator
University of Pavia