Clinical trial NCT06765343: Efficacy of Guided Biofilm Therapy in Pediatric Patient
Official title: Efficacy of Guided Biofilm Therapy in Pediatric Patient: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Hygiene, Oral Health
Pediatric Pain and Anxiety
Keywords: guided biofilm therapy
discloser agent
airflowing
polishing
patient feedback
Lead sponsor: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 120
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, mono-centric, 2 by 2 parallel
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Residual Plaque Area (RPA)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Full Mouth Plaque Score (FMPS)
timeFrame: Through study completion, an average of 1 year
measure: Time Session
timeFrame: Through study completion, an average of 1 year
measure: Participant Feedback
timeFrame: Through study completion, an average of 1 year
measure: Operator Feedback
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: ASST Spedali Civili di Brescia
Study officials:
References: