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Efficacy of Guided Biofilm Therapy in Pediatric Patient

NCT06765343 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-09

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-06
Primary Completion
2024-07-22
Completion
2024-09-12

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06765343 on ClinicalTrials.gov