Dental PlaquePhase 1/2NCT05805761
Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria
A Phase 1/2 study testing Conventional Treatment and Antimicrobial Photodynamic Therapy in people with Dental Plaque, run by University of Nove de Julho.
Trial summary
The objective of this study is to investigate the effect of Antimicrobial Photodynamic Therapy mediated by Erythrosine and blue LED in the reduction of bacteria in dental biofilm. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque
- What is being tested?
- Conventional Treatment and Antimicrobial Photodynamic Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 20 Aug 2023to 20 Dec 2023
- Phase
- Phase 1/2
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- The participant must present between 25% and 50% of biofilm index;
- Have at least 20 teeth present, without clinical probing depths greater than 3 mm.
Who cannot join
- Smokers;
- Uncontrolled diabetics or hypertensives;
- Cancer or its treatment;
- Pregnant women;
- Use of antibiotics in the last 6 months;
- Coagulation disorders (use of anticoagulants, presence of liver diseases, thrombocytopenia and immunosuppression);
- Patients undergoing orthodontic treatment.
About this study
Official title: Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria - Study Protocol for Randomized Clinical Trial
The objective of this study is to investigate the effect of Antimicrobial Photodynamic Therapy mediated by Erythrosine and blue LED in the reduction of bacteria in dental biofilm. This clinical trial will be carried out with 30 patients who have biofilm, but without the presence of periodontal pockets, and who are being treated at the Dental Clinic of Universidade Metropolitana de Santos. A split-mouth model will be used (n = 30), with group I control - conventional treatment and group II - conventional treatment and antimicrobial photodynamic therapy (aPDT). The bicarbonate jet will be used to remove dental biofilm in both groups. The treatment will be carried out in 1 session. aPDT will be performed before cleaning/prophylaxis, only in group II. Participants will rinse with the photosensitizer erythrosine (diluted to 1mM) for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. Then, the D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2. The microbiological examination will be performed from samples of supragingival biofilm collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the irradiation procedure (group II) or prophylaxis (groups I and II). Biofilm samples will be collected before and after exposure, respectively, and sent to the microbiological laboratory for colony counting. After this period, the CFU's will be counted and the data will be submitted to statistical analysis for comparison of pre and post-treatment results and between groups (conventional X aPDT).
- Conditions
- Dental Plaque
- Being tested
- Conventional Treatment, Antimicrobial Photodynamic Therapy
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional TreatmentProcedure or surgery
A bicarbonate jet will be used to remove the biofilm from the surface of the teeth.
Antimicrobial Photodynamic TherapyProcedure or surgery
aPDT will be performed before each cleaning/prophylaxis session, only in one of the groups. Participants will swish with the photosensitizer erythrosine for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. The D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Treatment Group | Experimental | Participants in this group will receive the conventional treatment for the removal of dental biofilm (prophylaxis with bicarbonate jet). Receives: Procedure: Conventional Treatment |
| aPDT + Conventional Treatment Group | Experimental | Participants in this group will receive both the antimicrobial photodynamic therapy and the conventional treatment (prophylaxis with bicarbonate jet) for the removal of dental biofilm. Receives: Procedure: Conventional Treatment; Procedure: Antimicrobial Photodynamic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Colony Forming Units
The microbiological examination will be carried out from biofilm samples collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the prophylaxis procedure or irradiation. To collect the subgingival biofilm, the teeth will be isolated with cotton rolls, the supragingival biofilm will be removed with sterile gauze, and the subgingival biofilm sample will be obtained by introducing a tip of sterile absorbent paper (#30) inside of the periodontal pocket, being kept in position for 30 s. The tips will be removed and stored in properly identified sterile plastic microtubes, each tube containing 1 mL of sterile Brain Heart Infusion (BHI) culture medium will be packed on ice and analyzed immediately after collection.
The samples will be used to determine the CFU's (Colony Forming Units). Each tube with 1 mL BHI will be vortexed and will undergo serial dilution from 10-1 to 10-5 times the original concentration.
Measured: Baseline and immediately after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start20 Aug 2023 (estimated)
- Primary completion20 Nov 2023 (estimated)
- Study completion20 Dec 2023 (estimated)
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 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcela Leticia Leal Gonçalves, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05805761
- Sponsor's protocol ID
- EritroBiofilm
- Status last verified
- Aug 2023
- First submitted
- 28 Mar 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sets generated in the study will be available from the corresponding author at a reasonable request. Once the data is entered electronically, participants identification details will no longer be attached to their data, they will be reported only by numbers. After the analysis of the data, volunteers will be invited to a meeting and the results will be shared, in case they wish to attend it. The authors intend to publish the results in a peer-review jornal and present them in cientific events.
Publications
Goncalves MLL, Sobral APT, Gallo JMAS, Gimenez T, Ferri EP, Ianello S, Motta PB, Motta LJ, Horliana ACRT, Santos EM, Bussadori SK. Antimicrobial photodynamic therapy with erythrosine and blue light on dental biofilm bacteria: study protocol for randomised clinical trial. BMJ Open. 2023 Sep 19;13(9):e075084. doi: 10.1136/bmjopen-2023-075084.
PubMed 37730405
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria - Study Protocol for Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05805761
- Acronym / sponsor ID
- EritroBiofilm
- Conditions
- Dental Plaque
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 20 Aug 2023 (estimated)
- Primary completion
- 20 Nov 2023 (estimated)
- Study completion
- 20 Dec 2023 (estimated)
- First posted
- 10 Apr 2023 (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.
The objective of this study is to investigate the effect of Antimicrobial Photodynamic Therapy mediated by Erythrosine and blue LED in the reduction of bacteria in dental biofilm. This clinical trial will be carried out with 30 patients who have biofilm, but without the presence of periodontal pockets, and who are being treated at the Dental Clinic of Universidade Metropolitana de Santos. A split-mouth model will be used (n = 30), with group I control - conventional treatment and group II - conventional treatment and antimicrobial photodynamic therapy (aPDT). The bicarbonate jet will be used to remove dental biofilm in both groups. The treatment will be carried out in 1 session. aPDT will be performed before cleaning/prophylaxis, only in group II. Participants will rinse with the photosensitizer erythrosine (diluted to 1mM) for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. Then, the D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2. The microbiological examination will be performed from samples of supragingival biofilm collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the irradiation procedure (group II) or prophylaxis (groups I and II). Biofilm samples will be collected before and after exposure, respectively, and sent to the microbiological laboratory for colony counting. After this period, the CFU's will be counted and the data will be submitted to statistical analysis for comparison of pre and post-treatment results and between groups (conventional X aPDT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Treatment Group | Experimental | Procedure: Conventional TreatmentParticipants in this group will receive the conventional treatment for the removal of dental biofilm (prophylaxis with bicarbonate jet). |
| aPDT + Conventional Treatment Group | Experimental | Procedure: Conventional Treatment, Procedure: Antimicrobial Photodynamic TherapyParticipants in this group will receive both the antimicrobial photodynamic therapy and the conventional treatment (prophylaxis with bicarbonate jet) for the removal of dental biofilm. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- The participant must present between 25% and 50% of biofilm index;
- Have at least 20 teeth present, without clinical probing depths greater than 3 mm.
Key exclusion criteria (7 listed)
- Smokers;
- Uncontrolled diabetics or hypertensives;
- Cancer or its treatment;
- Pregnant women;
- Use of antibiotics in the last 6 months;
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 |
|---|---|---|
| Conventional TreatmentA bicarbonate jet will be used to remove the biofilm from the surface of the teeth. | Procedure or surgery | Conventional Treatment Group, aPDT + Conventional Treatment Group |
| Antimicrobial Photodynamic TherapyaPDT will be performed before each cleaning/prophylaxis session, only in one of the groups. Participants will swish with the photosensitizer erythrosine for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. The D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2. | Procedure or surgery | aPDT + Conventional Treatment Group |
Primary outcome
Changes in Colony Forming Units
Time frame: Baseline and immediately after treatment.
The microbiological examination will be carried out from biofilm samples collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the prophylaxis procedure or irradiation. To collect the subgingival biofilm, the teeth will be isolated with cotton rolls, the supragingival biofilm will be removed with sterile gauze, and the subgingival biofilm sample will be obtained by introducing a tip of sterile absorbent paper (#30) inside of the periodontal pocket, being kept in position for 30 s. The tips will be removed and stored in properly identified sterile plastic microtubes, each tube containing 1 mL of sterile Brain Heart Infusion (BHI) culture medium will be packed on ice and analyzed immediately after collection. The samples will be used to determine the CFU's (Colony Forming Units). Each tube with 1 mL BHI will be vortexed and will undergo serial dilution from 10-1 to 10-5 times the original concentration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Derived from this study: PubMed 37730405Goncalves MLL, Sobral APT, Gallo JMAS, Gimenez T, Ferri EP, Ianello S, Motta PB, Motta LJ, Horliana ACRT, Santos EM, Bussadori SK. Antimicrobial photodynamic therapy with erythrosine and blue light on dental biofilm bacteria: study protocol for randomised clinical trial. BMJ Open. 2023 Sep 19;13(9):e075084. doi: 10.1136/bmjopen-2023-075084.
- Individual participant dataSharing planned: Yes. The data sets generated in the study will be available from the corresponding author at a reasonable request. Once the data is entered electronically, participants identification details will no longer be attached to their data, they will be reported only by numbers. After the analysis of the data, volunteers will be invited to a meeting and the results will be shared, in case they wish to attend it. The authors intend to publish the results in a peer-review jornal and present them in cientific events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Conventional Treatment and Antimicrobial Photodynamic Therapy 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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Aug 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Changes in Colony Forming Units (time frame: Baseline and immediately after treatment.). 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 NCT05805761, 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 3 Aug 2023.