Efficacy of Guided Biofilm Therapy in Pediatric Patient (BABYPLAK)

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

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.

Study Overview

• Status: Completed
• Conditions: Oral Hygiene, Oral Health; Pediatric Pain and Anxiety
• Intervention / Treatment: Device: Plaque disclosing agent; Device: Guided Biofilm Therapy; Device: Ultrasonic debridement and polishing

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Brescia, Italy, 25123
    • ASST Spedali Civili di Brescia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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
Experimental: 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.	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
Experimental: 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.	Device: Plaque disclosing agent; Dye agent binding to oral biofilm and plaque for visual detection; 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
Active Comparator: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Residual Plaque Area (RPA)	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	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Full Mouth Plaque Score (FMPS)	The percentage of full mouth residual plaque detected with plaque disclosing agent after the treatment	Through study completion, an average of 1 year
Time Session	The duration of treatment is noted and compared between groups	Through study completion, an average of 1 year
Participant Feedback	A satisfaction questionnaire (VAS Scale) is administered to the participant	Through study completion, an average of 1 year
Operator Feedback	A satisfaction questionnaire (VAS Scale) is administered to the operator	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): July 22, 2024
• Study Completion (Actual): September 12, 2024

Study Registration Dates

• First Submitted: November 28, 2024
• First Submitted That Met QC Criteria: January 8, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 8, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: patient feedback; polishing; guided biofilm therapy; discloser agent; airflowing
• Other Study ID Numbers: BABYPLAK NP 5675

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No