ASST Spedali Civili di Brescia
Brescia, 25123, Italy
NCT Number: NCT06765343
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.
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Notify Me6 year–12 year
All sexes
Interventional
Not applicable
Brescia, 25123, Italy
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dye agent binding to oral biofilm and plaque for visual detection
Utilisation of a air-polishing device conveying a jet of air, water and erythritol powder for plaque debridement on dental surfaces, followed by calculus removal with an ultrasonic scaler
Removal of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste
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
Time frame: Through study completion, an average of 1 year
The percentage of full mouth residual plaque detected with plaque disclosing agent after the treatment
Time frame: Through study completion, an average of 1 year
The duration of treatment is noted and compared between groups
Time frame: Through study completion, an average of 1 year
A satisfaction questionnaire (VAS Scale) is administered to the participant
Time frame: Through study completion, an average of 1 year
A satisfaction questionnaire (VAS Scale) is administered to the operator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Other
Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial
Acronym: BABYPLAK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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