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Completed

NCT Number: NCT06765343

Efficacy of Guided Biofilm Therapy in Pediatric Patient

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ASST Spedali Civili di Brescia

Brescia, 25123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Plaque disclosing agent

Device

Dye agent binding to oral biofilm and plaque for visual detection

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

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

Primary outcomes

  1. Residual Plaque Area (RPA)

    Time frame: 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 outcomes

  1. Full Mouth Plaque Score (FMPS)

    Time frame: Through study completion, an average of 1 year

    The percentage of full mouth residual plaque detected with plaque disclosing agent after the treatment

  2. Time Session

    Time frame: Through study completion, an average of 1 year

    The duration of treatment is noted and compared between groups

  3. Participant Feedback

    Time frame: Through study completion, an average of 1 year

    A satisfaction questionnaire (VAS Scale) is administered to the participant

  4. Operator Feedback

    Time frame: Through study completion, an average of 1 year

    A satisfaction questionnaire (VAS Scale) is administered to the operator

Sponsors and collaborators

Lead sponsor

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Other

Registry information

Official study title

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

Acronym: BABYPLAK

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2025
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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