Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Residual Plaque Area (RPA)
研究概览
简要总结
The present parallel randomized clinical trial aims to assess the efficacy of a plaque disclosing agent (PDA) and air-flowing with erythritol powder (Guided Biofilm Therapy) in the removal of biofilm and plaque in paediatric participants during professional oral hygiene, compared with ultrasonic debridement.
The participants will be divided in four groups and receive:
- Guided Biofilm Therapy with plaque disclosing agent (GBT+)
- Guided Biofilm Therapy without plaque disclosing agent (GBT-)
- Ultrasonic debridement and polishing with plaque disclosing agent (US+C+)
- Ultrasonic debridement and polishing without plaque disclosing agent (US+C-)
Clinical and image software analysis (ImageJ) of residual plaque will be performed.
详细描述
Oral biofilm is not easily detectable visually, so its removal can be difficult. Using a plaque disclosing agent to highlight biofilm and plaque could aid during its removal and may be beneficial.
In paediatric patients, often times it is more difficult to perform professional oral hygiene because of lack of compliance. Our hypothesis is that the visual guide of the plaque disclosing might help obtaining a better result in terms of plaque removal. Moreover, the use of air-flowing could lead to several advantages compared to traditional professional oral hygiene (ultrasonic debridement and polishing cups), such as increased comfort and compliance, shorter treatment time, easier access to difficult areas and the minimal-invasiveness on soft and hard tissue.
The study is a mono-centric, pragmatic, single-blinded, randomized clinical trial (RCT) of parallel design.
The primary outcome is the Residual Plaque Area (RPA) expressed in percentage of area with residual plaque highlighted by disclosing plaque agent. Secondary outcomes are Full Mouth Plaque Score (FMPS), treatment time and participants' feedback.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed Informed Consent Form (pediatric patient and parent).
- •Male and female subjects, aged 6 -12 years, inclusive.
- •Good general health (ASA I e II)
- •With at least 80% of dentition present
- •With at least 8/12 frontal dental elements.
排除标准
- •Not willing to follow the agreed protocol.
- •Presence of orthodontic appliances.
- •Tumors or significant pathology of the soft or hard tissues of the oral cavity.
- •Current radiotherapy or chemotherapy.
- •History of allergy to Erythritol.
- •History of adverse reactions to lactose or fermented milk products.
研究组 & 干预措施
Ultrasonic debridement and polishing with plaque disclosing (US+C+)
Participants assigned to the US+C+ receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant.
干预措施: Plaque disclosing agent (Device)
Guided biofilm therapy with plaque disclosing (GBT+)
Participants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant.
干预措施: Plaque disclosing agent (Device)
Guided biofilm therapy with plaque disclosing (GBT+)
Participants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant.
干预措施: Guided Biofilm Therapy (Device)
Guided biofilm therapy without plaque disclosing (GBT-)
Participants assigned to the GBT+ receive professional air-flowing oral hygiene with erythritol powder followed by ultrasonic calculus removal, without the guide of a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant.
干预措施: Guided Biofilm Therapy (Device)
Ultrasonic debridement and polishing with plaque disclosing (US+C+)
Participants assigned to the US+C+ receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) guided by a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant.
干预措施: Ultrasonic debridement and polishing (Device)
Ultrasonic debridement and polishing without plaque disclosing (US+C-)
Participant assigned to the US+C- receive traditional professional oral hygiene (ultrasonic tip followed by rubber cup and polishing paste) without the guide of a plaque disclosing agent. At the and of the treatment the investigator notes the treatment time, places the disclosing agent, takes a standardised intra-oral picture, records the FMPS (full mouth plaque score) and administers a feedback questionnaire to the participant.
干预措施: Ultrasonic debridement and polishing (Device)
结局指标
主要结局
Residual Plaque Area (RPA)
时间窗: Through study completion, an average of 1 year
The percentage of area on which plaque is still present, as revealed by reapplication of a plaque disclosing agent, at the end of the treatment session. An intra-oral picture is taken and it is analyzed with a specific software: ImageJ
次要结局
- Full Mouth Plaque Score (FMPS)(Through study completion, an average of 1 year)
- Time Session(Through study completion, an average of 1 year)
- Participant Feedback(Through study completion, an average of 1 year)
- Operator Feedback(Through study completion, an average of 1 year)
研究者
Magda Mensi
Researcher
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia