Efficacy of Guided Biofilm Therapy in Pediatric Patient

NCT06765343 | Completed

• 1 other identifier: BABYPLAK NP 5675
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Hygiene, Oral Health; Pediatric Pain and Anxiety

Keywords

guided biofilm therapy; discloser agent; airflowing; polishing; patient feedback

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Full Mouth Plaque Score (FMPS)

  Through study completion, an average of 1 year

• Time Session

  Through study completion, an average of 1 year

• Participant Feedback

  Through study completion, an average of 1 year

• Operator Feedback

  Through study completion, an average of 1 year

Study Arms (4)

Guided biofilm therapy with plaque disclosing (GBT+)

EXPERIMENTAL

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; Device: Guided Biofilm Therapy

Guided biofilm therapy without plaque disclosing (GBT-)

EXPERIMENTAL

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

Ultrasonic debridement and polishing with plaque disclosing (US+C+)

EXPERIMENTAL

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; Device: Ultrasonic debridement and polishing

Ultrasonic debridement and polishing without plaque disclosing (US+C-)

ACTIVE COMPARATOR

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

Interventions

Plaque disclosing agent DEVICE

Dye agent binding to oral biofilm and plaque for visual detection

Guided biofilm therapy with plaque disclosing (GBT+); Ultrasonic debridement and polishing with plaque disclosing (US+C+)

Guided Biofilm Therapy 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 with plaque disclosing (GBT+); Guided biofilm therapy without plaque disclosing (GBT-)

Ultrasonic debridement and polishing 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 with plaque disclosing (US+C+); Ultrasonic debridement and polishing without plaque disclosing (US+C-)

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Model Details: Randomized clinical trial, mono-centric, 2 by 2 parallel

Study Record Dates

• First Submitted: November 28, 2024
• First Posted: January 9, 2025
• Study Start: March 6, 2023
• Primary Completion: July 22, 2024
• Study Completion: September 12, 2024
• Last Updated: January 9, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)