Efficacy of Air Polishing on Pain Perception and Compliance With Supportive Periodontal Therapy: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain perceived during supportive periodontal therapy
研究概览
简要总结
Supportive periodontal therapy (SPT) is essential for maintaining periodontal stability and preventing disease recurrence in patients who have been successfully treated for periodontitis. However, long-term effectiveness depends on regular attendance at maintenance visits, and negative experiences associated with periodontal instrumentation, such as pain or discomfort, may affect patient acceptance and adherence to the maintenance program.
The aim of this randomized clinical trial is to evaluate whether supportive periodontal therapy performed using an air-polishing device with low-abrasive trehalose powder reduces patient-perceived pain and improves the clinical experience compared with conventional biofilm removal using ultrasonic instrumentation. The study will also assess whether the use of air polishing is associated with better adherence to the periodontal maintenance program while maintaining comparable periodontal clinical outcomes.
Forty periodontally stabilized adult patients enrolled in the supportive periodontal therapy program of the Master's Degree in Periodontology and Peri-implantology at the University of Barcelona will be randomly allocated in a 1:1 ratio to one of two parallel treatment groups. The control group will receive conventional supportive periodontal therapy using ultrasonic instrumentation, while the experimental group will receive supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder. Participants will be followed for 24 months.
The primary outcome will be patient-perceived pain associated with supportive periodontal therapy, assessed using a visual analogue scale (VAS). Secondary outcomes will include treatment duration, adherence to scheduled maintenance visits, patient experience and acceptance of treatment, and periodontal clinical parameters. Periodontal status will be monitored throughout follow-up by assessing probing pocket depth, clinical attachment level, bleeding on probing, and plaque index.
This study aims to determine whether air polishing with trehalose powder can provide a more comfortable and patient-centered approach to supportive periodontal therapy without compromising periodontal clinical outcomes, and whether an improved treatment experience may contribute to better long-term adherence to periodontal maintenance.
详细描述
Periodontitis is a chronic inflammatory disease that requires long-term supportive periodontal therapy (SPT) after completion of active periodontal treatment in order to maintain periodontal stability and reduce the risk of disease recurrence. The effectiveness of SPT is strongly influenced by long-term patient adherence. Therefore, improving patient comfort and treatment experience during maintenance visits may contribute to better adherence to periodontal maintenance programs.
Conventional SPT commonly involves mechanical removal of supra- and subgingival biofilm and deposits using ultrasonic instrumentation. Air-polishing devices using low-abrasive powders have been proposed as an alternative approach for biofilm removal during periodontal maintenance. Previous studies suggest that air polishing may provide effective biofilm removal while reducing patient discomfort and treatment time. However, evidence regarding the use of newer-generation air-polishing systems with trehalose-based powder during SPT remains limited. This study will therefore evaluate both patient-reported outcomes and periodontal clinical outcomes associated with this approach.
This study is designed as a randomized, superiority, parallel-group clinical trial with a 24-month follow-up period. A total of 40 periodontally stabilized adult patients enrolled in the SPT program of the Master's Degree in Periodontology and Peri-implantology at the University of Barcelona will be included. Participants who meet the eligibility criteria and provide written informed consent will be randomly allocated in a 1:1 ratio to either the experimental group or the control group, with an expected sample of 20 participants per group.
Participants allocated to the control group will receive conventional biofilm removal using ultrasonic instrumentation during supportive periodontal therapy. Participants allocated to the experimental group will receive supportive periodontal therapy using an air-polishing device with low-abrasive trehalose powder. The purpose of this comparison is to determine whether the air-polishing approach reduces patient-perceived pain and improves the overall treatment experience and adherence to the maintenance program compared with conventional ultrasonic instrumentation, while maintaining comparable periodontal clinical outcomes.
Participants will be prospectively evaluated at baseline and during follow-up visits over a period of 24 months. Maintenance visits will be performed every 6 months. At each maintenance visit, a complete periodontal examination will be performed. Periodontal clinical parameters will include probing pocket depth, clinical attachment level, bleeding on probing, and plaque index.
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
The outcome assessor will be blinded to treatment allocation. Due to the nature of the interventions, the operator performing supportive periodontal therapy cannot be blinded.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
- •ASA physical status I or II.
- •Initial diagnosis of Stage I-III periodontitis according to the 2017 World Workshop, periodontally treated and stabilized, and enrolled in a supportive periodontal therapy (SPT) program.
- •Non-smokers or light smokers (<10 cigarettes/day).
- •Commitment to attend all follow-up visits over the 24-month study period.
排除标准
- •Patients requiring local anesthesia or anxiolytic premedication to undergo supportive periodontal therapy (SPT).
- •Patients with pacemakers, implantable cardioverter-defibrillators, or neurostimulators.
- •Pregnant women.
- •Patients with infectious respiratory diseases.
- •Patients with systemic diseases or neurological disorders that may alter pain perception.
- •Patients receiving medications that may influence pain perception (e.g., opioids or gabapentin).
研究组 & 干预措施
Trehalose Air-Polishing Group
Participants allocated to this group will receive supportive periodontal therapy (SPT) using an air-polishing device with low-abrasive trehalose powder for subgingival biofilm removal.
干预措施: Trehalose Air-Polishing (Device)
Ultrasonic Instrumentation Group
Participants allocated to this group will receive supportive periodontal therapy (SPT) using conventional ultrasonic instrumentation for subgingival biofilm and calculus removal.
干预措施: Ultrasonic Instrumentation (Device)
结局指标
主要结局
Pain perceived during supportive periodontal therapy
时间窗: Immediately after the supportive periodontal therapy session
Pain perceived by the participant during the supportive periodontal therapy session will be assessed using a Visual Analogue Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain). The outcome will be compared between participants treated with trehalose air-polishing and those treated with ultrasonic instrumentation.
次要结局
- Patient-reported treatment experience(Immediately after each supportive periodontal therapy session)
- Duration of supportive periodontal therapy session(At each supportive periodontal therapy visit throughout the 24-month follow-up)
- Adherence to supportive periodontal therapy(Throughout the 24-month follow-up)
- Probing pocket depth (PPD)(Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up)
- Clinical attachment level (CAL)(Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.)
- Gingival margin position (MG)(Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.)
- Bleeding on probin (BoP)(Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.)
- Plaque index (PI)(Baseline and at each supportive periodontal therapy visit throughout the 24-month follow-up.)
- Patient knowledge and awareness of supportive periodontal therapy(Throughout the 24-month follow-up)
- Patient-reported perceived knowledge of periodontal disease and supportive periodontal therapy(Throughout the 24-month follow-up.)
研究者
Octavi Camps-Font
Associate Professor
University of Barcelona