Dental PlaqueNCT07539181
Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children
A study testing Mechanical Prophylaxis, aPDT with Erythrosine and aPDT with GC TriPlaque ID Gel in people with Dental Plaque, run by University of Nove de Julho.
Trial summary
This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Mechanical Prophylaxis, aPDT with Erythrosine and aPDT with GC TriPlaque ID Gel
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2026to 30 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to 7 years
- Both sexes
- Good general health status
- Classified as high caries risk according to the CAMBRA protocol (score ≥ +4 or presence of at least one disease indicator associated with two or more biological risk factors)
- Written informed consent obtained from a parent or legal guardian
Who cannot join
- Presence of systemic diseases
- Use of antibiotics within the last 30 days
- Use of antimicrobial mouthwash within 48 hours prior to sample collection
- Presence of structural dental alterations that may interfere with the standardization of the procedure
- Uncooperative behavior preventing safe clinical examination and intervention
About this study
Official title: Disclosing Agents as Photosensitizers in Antimicrobial Photodynamic Therapy for Biofilm Control in Children Aged 3 to 7 Years: A Randomized Controlled Trial
This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Participants will be allocated into groups to receive different treatment protocols, and biofilm levels will be assessed before and after the interventions. The primary outcome is the reduction of dental biofilm, aiming to determine whether disclosing agents can be an effective alternative photosensitizer in aPDT for pediatric patients.
Read the detailed description
This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Dental biofilm is a major etiological factor for dental caries, especially in pediatric populations, and alternative strategies for its control are relevant in minimally invasive dentistry. A total of 72 children will be randomly allocated into three parallel groups (n = 24 per group): (1) mechanical prophylaxis (control group), (2) aPDT using erythrosine as a photosensitizer, and (3) aPDT using GC TriPlaque ID Gel as a photosensitizer. In the experimental groups, the photosensitizer will be applied to the dental surface followed by blue light-emitting diode (LED) irradiation using a dental curing light. In the control group, only mechanical prophylaxis will be performed using a Robinson brush at low speed with water. Dental biofilm samples will be collected from the cervical vestibular surface of primary molars before and immediately after the intervention. Microbiological analysis will be performed to quantify colony-forming units per milliliter (CFU/mL), allowing the evaluation of antimicrobial effectiveness. Secondary outcomes include clinical feasibility, assessed by the duration of the procedure using a stopwatch, and behavioral acceptance, evaluated using the Frankl Behavior Rating Scale. The study is designed as a single-blind trial, in which the outcomes assessor is blinded to group allocation.
- Conditions
- Dental Plaque
- Being tested
- Mechanical Prophylaxis, aPDT with Erythrosine, aPDT with GC TriPlaque ID Gel
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical ProphylaxisProcedure or surgery
Also called Dental cleaning
Mechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation.
aPDT with ErythrosineProcedure or surgery
Also called Antimicrobial photodynamic therapy with erythrosine
Application of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.
aPDT with GC TriPlaque ID GelProcedure or surgery
Also called Antimicrobial photodynamic therapy with GC TriPlaque ID Gel
Application of GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Prophylaxis (Control) | Active comparator | Participants will receive mechanical prophylaxis using a Robinson brush at low speed with water, without the use of photosensitizers or blue LED irradiation. Receives: Procedure: Mechanical Prophylaxis |
| aPDT with Erythrosine | Experimental | Participants will receive antimicrobial photodynamic therapy (aPDT) using erythrosine as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection. Receives: Procedure: aPDT with Erythrosine |
| aPDT with GC TriPlaque ID Gel | Experimental | Participants will receive antimicrobial photodynamic therapy (aPDT) using GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection. Receives: Procedure: aPDT with GC TriPlaque ID Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in microbial load of dental biofilm (CFU/mL)
Quantitative analysis of colony-forming units (CFU/mL) in dental biofilm samples collected from the cervical vestibular surface of primary molars to assess microbial load reduction after intervention. Samples will be obtained before and after treatment and processed for microbiological evaluation.
Measured: Baseline and immediately after the intervention
Secondary outcomes (2)
Clinical feasibility of the protocol
Assessment of the total duration of the clinical procedure, measured in minutes using a stopwatch from the beginning to the end of the intervention, to evaluate the feasibility of the protocol in pediatric patients.
Measured: Baseline and Periprocedural
Child behavioral acceptance
Behavioral response of children during the clinical procedure assessed using the Frankl Behavior Rating Scale (scores 1 to 4), evaluating cooperation and acceptance of the treatment.
Measured: Baseline and Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start31 May 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- Participants will be randomly assigned to three parallel groups: mechanical prophylaxis (control), antimicrobial photodynamic therapy (aPDT) with erythrosine, and aPDT with GC TriPlaque ID Gel. Microbiological outcomes will be assessed before and after the interventions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539181
- Sponsor's protocol ID
- EVIDENCIADORES
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disclosing Agents as Photosensitizers in Antimicrobial Photodynamic Therapy for Biofilm Control in Children Aged 3 to 7 Years: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07539181
- Acronym / sponsor ID
- EVIDENCIADORES
- Conditions
- Dental Plaque
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 31 May 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 20 Apr 2026 (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.
This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Participants will be allocated into groups to receive different treatment protocols, and biofilm levels will be assessed before and after the interventions. The primary outcome is the reduction of dental biofilm, aiming to determine whether disclosing agents can be an effective alternative photosensitizer in aPDT for pediatric patients.
Detailed description
This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Dental biofilm is a major etiological factor for dental caries, especially in pediatric populations, and alternative strategies for its control are relevant in minimally invasive dentistry. A total of 72 children will be randomly allocated into three parallel groups (n = 24 per group): (1) mechanical prophylaxis (control group), (2) aPDT using erythrosine as a photosensitizer, and (3) aPDT using GC TriPlaque ID Gel as a photosensitizer. In the experimental groups, the photosensitizer will be applied to the dental surface followed by blue light-emitting diode (LED) irradiation using a dental curing light. In the control group, only mechanical prophylaxis will be performed using a Robinson brush at low speed with water. Dental biofilm samples will be collected from the cervical vestibular surface of primary molars before and immediately after the intervention. Microbiological analysis will be performed to quantify colony-forming units per milliliter (CFU/mL), allowing the evaluation of antimicrobial effectiveness. Secondary outcomes include clinical feasibility, assessed by the duration of the procedure using a stopwatch, and behavioral acceptance, evaluated using the Frankl Behavior Rating Scale. The study is designed as a single-blind trial, in which the outcomes assessor is blinded to group allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to three parallel groups: mechanical prophylaxis (control), antimicrobial photodynamic therapy (aPDT) with erythrosine, and aPDT with GC TriPlaque ID Gel. Microbiological outcomes will be assessed before and after the interventions.
| Arm | Type | Receives |
|---|---|---|
| Mechanical Prophylaxis (Control) | Active comparator | Procedure: Mechanical ProphylaxisParticipants will receive mechanical prophylaxis using a Robinson brush at low speed with water, without the use of photosensitizers or blue LED irradiation. |
| aPDT with Erythrosine | Experimental | Procedure: aPDT with ErythrosineParticipants will receive antimicrobial photodynamic therapy (aPDT) using erythrosine as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection. |
| aPDT with GC TriPlaque ID Gel | Experimental | Procedure: aPDT with GC TriPlaque ID GelParticipants will receive antimicrobial photodynamic therapy (aPDT) using GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 3 to 7 years
- Both sexes
- Good general health status
- Classified as high caries risk according to the CAMBRA protocol (score ≥ +4 or presence of at least one disease indicator associated with two or more biological risk factors)
- Written informed consent obtained from a parent or legal guardian
Key exclusion criteria (5 listed)
- Presence of systemic diseases
- Use of antibiotics within the last 30 days
- Use of antimicrobial mouthwash within 48 hours prior to sample collection
- Presence of structural dental alterations that may interfere with the standardization of the procedure
- Uncooperative behavior preventing safe clinical examination and intervention
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 |
|---|---|---|
| Mechanical ProphylaxisAlso: Dental cleaningMechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation. | Procedure or surgery | Mechanical Prophylaxis (Control) |
| aPDT with ErythrosineAlso: Antimicrobial photodynamic therapy with erythrosineApplication of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy. | Procedure or surgery | aPDT with Erythrosine |
| aPDT with GC TriPlaque ID GelAlso: Antimicrobial photodynamic therapy with GC TriPlaque ID GelApplication of GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy. | Procedure or surgery | aPDT with GC TriPlaque ID Gel |
Primary outcome
Reduction in microbial load of dental biofilm (CFU/mL)
Time frame: Baseline and immediately after the intervention
Quantitative analysis of colony-forming units (CFU/mL) in dental biofilm samples collected from the cervical vestibular surface of primary molars to assess microbial load reduction after intervention. Samples will be obtained before and after treatment and processed for microbiological evaluation.
2 secondary outcomes
Clinical feasibility of the protocol
Time frame: Baseline and Periprocedural
Child behavioral acceptance
Time frame: Baseline and Periprocedural
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Prophylaxis, aPDT with Erythrosine and aPDT with GC TriPlaque ID Gel in people with Dental Plaque, run by University of Nove de Julho.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Reduction in microbial load of dental biofilm (CFU/mL) (time frame: Baseline and immediately after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.