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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:
Clinical and image software analysis (ImageJ) of residual plaque will be performed.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plaque disclosing agent | Device | Dye agent binding to oral biofilm and plaque for visual detection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Full Mouth Plaque Score (FMPS) | The percentage of full mouth residual plaque detected with plaque disclosing agent after the treatment | Through study completion, an average of 1 year |
| Time Session |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ASST Spedali Civili di Brescia | Brescia | 25123 | Italy |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2022 | Nov 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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Randomized clinical trial, mono-centric, 2 by 2 parallel
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| 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. |
|
| 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 |
|
The duration of treatment is noted and compared between groups
| Through study completion, an average of 1 year |
| Participant Feedback | A satisfaction questionnaire (VAS Scale) is administered to the participant | Through study completion, an average of 1 year |
| Operator Feedback | A satisfaction questionnaire (VAS Scale) is administered to the operator | Through study completion, an average of 1 year |