NCT06765343

Efficacy of Guided Biofilm Therapy in Pediatric Patient

Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Accepted

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.

Conditions

• Oral Hygiene, Oral Health
• Pediatric Pain and Anxiety

Interventions

Type	Name	Description
DEVICE	Plaque disclosing agent	Dye agent binding to oral biofilm and plaque for visual detection
DEVICE	Guided 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
DEVICE	Ultrasonic debridement and polishing	Removal of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste

Timeline

• Start date: 2023-03-06
• Primary completion: 2024-07-22
• Completion: 2024-09-12
• First posted: 2025-01-09
• Last updated: 2025-01-09

Locations

1 site across 1 country: Italy