PlaqueORTOPLAKNCT05428189
Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients.
A study testing Plaque Disclosing Agent and Airpolishing and ultrasonic debridement in people with Plaque, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
Trial summary
It is more difficult to perform excellent professional oral hygiene in patients wearing orthodontic appliances. The hypothesis of the present randomized controlled trial is that the application of plaque disclosing agent allows better biofilm removal. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque
- What is being tested?
- Plaque Disclosing Agent and Airpolishing and ultrasonic debridement
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2020to 25 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed Informed Consent Form;
- Male and female subjects, aged 18-75 years, inclusive;
- Presence of orthodontic appliances;
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives);
- Generalized gingivitis;
- Plaque index (PI) above 25%;
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- Availability for session of the study for an assigned subject;
- Presence of all inferior and superior anterior teeth from canine to canine;
- Smoking less than 10 cigarettes a day.
Who cannot join
- Chronic obstructive pulmonary disease and asthma;
- Patients with periodontally disease defined as presence of PPD >= 4mm and /or PAL of >=3m;
- Splinted teeth;
- Presence of prosthesis;
- Tumors or significant pathology of the soft or hard tissues of the oral cavity;
- Current radiotherapy or chemotherapy;
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- Pregnant or lactating women;
- History of allergy to Erythritol;
- History of adverse reactions to lactose or fermented milk products;
- Restorations on the teeth to be treated which may interfere with treatment administration and/or scoring procedures, at the discretion of the examiner;
- Not willing to follow the agreed protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients: a Randomised Controlled Trial Study
It is more difficult to perform excellent professional oral hygiene in patients wearing orthodontic appliances.
The hypothesis of the present randomized controlled trial is that the application of plaque disclosing agent allows better biofilm removal.
Read more
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups:
- CONTROL GROUP will receive professional oral hygiene without disclosing agent
- TEST GROUP will receive professional oral hygiene guided by plaque disclosing agent
At the end of the professional oral hygiene session, the disclosing agent is re-applied in all patients and the percentage of residual plaque area is calculated though image software analysis (ImageJ).
Read the detailed description
Oral biofilm is not always visible, so its complete removal can be challenging. Applying a plaque disclosing agent before the therapy might serve as a guide to better remove biofilm. Thanks to this tool, the clinicians can clearly see where the plaque is, so its removal can be more thorough.
In orthodontic patients, it is even more difficult to remove biofilm and plaque, as the fixed appliances pose an obstacle. The hypothesis is that using a plaque disclosing agent as a guide to the operator, better removal of the biofilm can be achieved.
The study will be performed to assess the efficacy of disclosing plaque agent as a guide to remove biofilm and plaque in orthodontic patients during professional oral hygiene, performed with air-polishing with erythritol powder and a ultrasonic device.
TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.
STUDY POPULATION: Orthodontic patients with plaque index above the 25% and without periodontal disease.
PRIMARY OUTCOME: the percentage of area in which the disclosing plaque agent is present after the treatment (RPA: Residual Plaque Area).
RPA: residual plaque area: percentage of area with residual plaque coloured by plaque disclosing agent. This will be analysed and calculated with a image analysis software (ImageJ).
- Conditions
- Plaque
- Being tested
- Plaque Disclosing Agent, Airpolishing and ultrasonic debridement
- Keywords
- Oral Hygiene, Dental Care, Orthodontic Patient, Disclosing Plaque Agent
- Medical subject headings
- Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plaque Disclosing AgentDiagnostic test
A plaque disclosing agent is applied on teeth to detect plaque. Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.
Airpolishing and ultrasonic debridementDevice
Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling.
| Study group | Role | What they receive |
|---|---|---|
| Guided Biofilm Therapy (GBT) | Experimental | The subjects receive professional oral hygiene guided by plaque a disclosing agent, using air-polishing and a ultrasonic device Receives: Diagnostic Test: Plaque Disclosing Agent; Device: Airpolishing and ultrasonic debridement |
| Air Polishing and Ultrasonic Debridment | Active comparator | The subject receive professional oral hygiene using air-polishing and a ultrasonic device Receives: Device: Airpolishing and ultrasonic debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Plaque Area (RPA)
The percentage of area in which plaque is still present, as revealed by re-application of plaque disclosing agent, in both groups at the end of the treatment session
Measured: At the end of the treatment session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start10 Oct 2020
- Primary completion25 May 2022
- Study completion25 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocetric, single blinded, randomized clinical trial, parallel design.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magda Mensi, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
- Investigators
- Magda Mensi, Principal investigator, Asst Degli Spedali Civili Di Brescia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428189
- Sponsor's protocol ID
- ORTOPLAK
- Acronym
- ORTOPLAK
- Status last verified
- Jun 2022
- First submitted
- 8 Jun 2022
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mensi M, Garzetti G, Scotti E, Marchetti S, Venturi C, Di Monda L, Sordillo A, Calza S. Plaque disclosing agent as a guide in biofilm removal in patients with fixed orthodontic appliance: a randomized clinical trial. Odontology. 2026 Apr 21. doi: 10.1007/s10266-026-01395-3. Online ahead of print.
PubMed 42012718
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Disclosing Plaque Agent as a Guide to Remove the Oral Biofilm in Orthodontic Patients: a Randomised Controlled Trial Study
- ClinicalTrials.gov ID
- NCT05428189
- Acronym / sponsor ID
- ORTOPLAK / ORTOPLAK
- Conditions
- Plaque
- Keywords
- Oral Hygiene, Dental Care, Orthodontic Patient, Disclosing Plaque Agent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaUniversity, hospital or other
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 22 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
It is more difficult to perform excellent professional oral hygiene in patients wearing orthodontic appliances.
The hypothesis of the present randomized controlled trial is that the application of plaque disclosing agent allows better biofilm removal.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups:
- CONTROL GROUP will receive professional oral hygiene without disclosing agent
- TEST GROUP will receive professional oral hygiene guided by plaque disclosing agent
At the end of the professional oral hygiene session, the disclosing agent is re-applied in all patients and the percentage of residual plaque area is calculated though image software analysis (ImageJ).
Detailed description
Oral biofilm is not always visible, so its complete removal can be challenging. Applying a plaque disclosing agent before the therapy might serve as a guide to better remove biofilm. Thanks to this tool, the clinicians can clearly see where the plaque is, so its removal can be more thorough.
In orthodontic patients, it is even more difficult to remove biofilm and plaque, as the fixed appliances pose an obstacle. The hypothesis is that using a plaque disclosing agent as a guide to the operator, better removal of the biofilm can be achieved.
The study will be performed to assess the efficacy of disclosing plaque agent as a guide to remove biofilm and plaque in orthodontic patients during professional oral hygiene, performed with air-polishing with erythritol powder and a ultrasonic device.
TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.
STUDY POPULATION: Orthodontic patients with plaque index above the 25% and without periodontal disease.
PRIMARY OUTCOME: the percentage of area in which the disclosing plaque agent is present after the treatment (RPA: Residual Plaque Area).
RPA: residual plaque area: percentage of area with residual plaque coloured by plaque disclosing agent. This will be analysed and calculated with a image analysis software (ImageJ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Monocetric, single blinded, randomized clinical trial, parallel design.
| Arm | Type | Receives |
|---|---|---|
| Guided Biofilm Therapy (GBT) | Experimental | Diagnostic Test: Plaque Disclosing Agent, Device: Airpolishing and ultrasonic debridementThe subjects receive professional oral hygiene guided by plaque a disclosing agent, using air-polishing and a ultrasonic device |
| Air Polishing and Ultrasonic Debridment | Active comparator | Device: Airpolishing and ultrasonic debridementThe subject receive professional oral hygiene using air-polishing and a ultrasonic device |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent Form;
- Male and female subjects, aged 18-75 years, inclusive;
- Presence of orthodontic appliances;
- Good general health (free of systemic diseases such as diabetes, HIV infection or genetic disorder, ongoing malignant disease of any type that could influence the outcome of the treatment and might interfere with the evaluation of the study objectives);
- Generalized gingivitis;
Key exclusion criteria (11 listed)
- Chronic obstructive pulmonary disease and asthma;
- Patients with periodontally disease defined as presence of PPD >= 4mm and /or PAL of >=3m;
- Splinted teeth;
- Presence of prosthesis;
- Tumors or significant pathology of the soft or hard tissues of the oral cavity;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plaque Disclosing AgentA plaque disclosing agent is applied on teeth to detect plaque. Air-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling. | Diagnostic test | Guided Biofilm Therapy (GBT) |
| Airpolishing and ultrasonic debridementAir-polishing will be used as main instrument for biofilm and stains removal, followed by ultrasonic scaling. | Device | Air Polishing and Ultrasonic Debridment, Guided Biofilm Therapy (GBT) |
Primary outcome
Residual Plaque Area (RPA)
Time frame: At the end of the treatment session
The percentage of area in which plaque is still present, as revealed by re-application of plaque disclosing agent, in both groups at the end of the treatment session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
- Derived from this study: PubMed 42012718Mensi M, Garzetti G, Scotti E, Marchetti S, Venturi C, Di Monda L, Sordillo A, Calza S. Plaque disclosing agent as a guide in biofilm removal in patients with fixed orthodontic appliance: a randomized clinical trial. Odontology. 2026 Apr 21. doi: 10.1007/s10266-026-01395-3. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Mensi principal investigator
Asst Degli Spedali Civili Di Brescia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plaque Disclosing Agent and Airpolishing and ultrasonic debridement in people with Plaque, run by Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual Plaque Area (RPA) (time frame: At the end of the treatment session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05428189, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.