The Efficacy of Full Mouth Erythritol Powder Air-Polishing Therapy (FM-EPAPT) Versus Traditional Ultrasonic Debridment (UD): a Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in Bleeding on Probing (BoP)
研究概览
简要总结
Traditional methods for plaque and calculus removal involve the use of mechanical and/or manual instruments, followed by surface polishing with rubber cups and low abrasive pastes. These instruments may cause the unintended removal of hard dental tissue, such as enamel, cementum and dentine, increasing surface roughness. Moreover, they can lead to gingival recession and consequent hypersensitivity and discomfort during treatment. New minimally-invasive approaches to biofilm removal have been recently introduced with the aim to limit the negative impact on the oral tissue. Air-polishing with low-abrasiveness powders are proven suitable for both for supra- and sub-gingival plaque removal. The use of low-abrasiveness powders could lead to several advantages, such as reduction of treatment discomfort, shorter treatment time, the possibility of cleaning areas with difficult access and minor damage on soft and hard tissues.
Aim: the aim of this study is to evaluate the efficacy of the Full Mouth Erithrytol Powder Air-Polishing Therapy compared to traditional ultrasonic debridment (UD) and polishing in patient affected by gingivitis.
Test hypotesis: there is no difference in clinical outcome between two methods against the hypothesis of a difference in terms of changes in Blending on Probing (BOP).
To test this hypothesis, the patients, upon initial evaluation, were treated in split mouth:
- The control group undergoing the standard procedure with full-mouth ultrasonic debridement and polishing with rubber cup and abrasive paste.
- The study group undergoing an innovative procedure involving full-mouth air-polishing followed by ultrasonic calculus removal.
Follow-ups are scheduled at 2 weeks and 1, 3, 6 and 12 months.
详细描述
TRIAL DESIGN:
Mono-centric, pragmatic, double-blinded, randomized clinical trial (RCT) with split-mouth design. The trial will have a one year of duration.
PRIMARY OUTCOME:
- Change in BoP: change in percentage of sites positive to bleeding on probing.
SECONDARY OUTCOMES:
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 (Investigator)
盲法说明
Clinical examination, collection of periodontal parameters and clinical photographs were performed by the same trained dentist blinded to the treatment.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of gingivitis (BoP > 25%);
- •Presence of at least 5 teeth per quadrant;
- •Systemically healthy;
- •Age between 20 and 40 years old.
排除标准
- •Presence of periodontal disease, defined as >3 mm of clinical attachment loss at any site;
- •Presence of fixed retainers, orthodontic appliances or complex prothetic restorations;
- •Presence of crowding;
- •Pregnant or lactating;
- •Allergy to chlorhexidine or erythritol;
- •Smoking >10 cigarettes per day;
- •Unwillingness to undergo the proposed treatment and recalls;
结局指标
主要结局
Change in Bleeding on Probing (BoP)
时间窗: study completion, an average of 18 months
Change in percentage of sites positive to bleeding on probing
次要结局
- Change in Plaque Index (PI)(From baseline to study completion (12 months))
- Change in Periodontal Attachment Level (PAL)(From baseline to study completion (12 months))
- Change in Pocket Probing Depth (PPD)(From baseline to study completion (12 months))
- Comfort of the patient(From baseline to study completion (12 months))
- Sensation of cleanliness(From baseline to study completion (12 months))
- Treatment time(From baseline to study completion (12 months))
- Change in residual plaque area (RPA)(From baseline to study completion (12 months))
研究者
Magda Mensi
principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia