Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Residual Plaque Area (RPA)
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 12 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: 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.
Intervention: Ultrasonic debridement and polishing (Device)
Outcomes
Primary Outcomes
Residual Plaque Area (RPA)
Time Frame: 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
Secondary Outcomes
- 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)
Investigators
Magda Mensi
Researcher
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia