Efficacy of Guided Biofilm Therapy in Pediatric Patient

NCT ID: NCT06765343

Last Updated: 2025-01-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-06
• Study Completion Date: 2024-09-12

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.

Conditions

Oral Hygiene, Oral Health; Pediatric Pain and Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Plaque disclosing agent

Intervention Type: DEVICE

Dye agent binding to oral biofilm and plaque for visual detection

Guided Biofilm Therapy

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Guided Biofilm Therapy

Intervention Type: DEVICE

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

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.

Group Type: EXPERIMENTAL

Plaque disclosing agent

Intervention Type: DEVICE

Dye agent binding to oral biofilm and plaque for visual detection

Ultrasonic debridement and polishing

Intervention Type: DEVICE

Removal of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste

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.

Group Type: ACTIVE_COMPARATOR

Ultrasonic debridement and polishing

Intervention Type: DEVICE

Removal of plaque and calculus with an ultrasonic scaler, followed by surface polishing with a rubber cup and abrasive paste

Interventions

Plaque disclosing agent

Dye agent binding to oral biofilm and plaque for visual detection

Intervention Type: 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

Intervention Type: 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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

OTHER

Sponsor Role: lead

Responsible Party

Magda Mensi

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ASST Spedali Civili di Brescia

Brescia, , Italy

Countries

Italy

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

BABYPLAK NP 5675

Identifier Type: -

Identifier Source: org_study_id