Efficacy of Guided Biofilm Therapy in Pediatric Patient

Not Applicable

Completed

• Conditions: Oral Hygiene, Oral Health; Pediatric Pain and Anxiety

• Registration Number: NCT06765343
• Lead Sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

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.

Study Timeline

• Study Start: 2023-03-06
• Primary Completion: 2024-07-22
• Study Completion: 2024-09-12
• Study First Submitted: 2024-11-28
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-08
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Residual Plaque Area (RPA)	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 Outcome Measures

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

Trial Locations

Locations (1)

ASST Spedali Civili di Brescia; 🇮🇹 Brescia, Italy