Oral Hygiene, Oral Health, Pediatric Pain and Anxiety
Conditions
Keywords
guided biofilm therapy, discloser agent, airflowing, polishing, patient feedback
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.
Interventions
DEVICEPlaque disclosing agent
Dye agent binding to oral biofilm and plaque for visual detection
DEVICEGuided Biofilm Therapy
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
DEVICEUltrasonic debridement and polishing
Removal of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste
Sponsors
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
Randomized clinical trial, mono-centric, 2 by 2 parallel
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Plaque Area (RPA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Full Mouth Plaque Score (FMPS) | Through study completion, an average of 1 year | The percentage of full mouth residual plaque detected with plaque disclosing agent after the treatment |
| Time Session | Through study completion, an average of 1 year | The duration of treatment is noted and compared between groups |
| Participant Feedback | Through study completion, an average of 1 year | A satisfaction questionnaire (VAS Scale) is administered to the participant |
| Operator Feedback | Through study completion, an average of 1 year | A satisfaction questionnaire (VAS Scale) is administered to the operator |
Countries
Italy
Outcome results
None listed