Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria

NCT ID: NCT05805761

Last Updated: 2023-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-20
• Study Completion Date: 2023-12-20

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional Treatment Group

Participants in this group will receive the conventional treatment for the removal of dental biofilm (prophylaxis with bicarbonate jet).

Group Type: EXPERIMENTAL

Conventional Treatment

Intervention Type: PROCEDURE

A bicarbonate jet will be used to remove the biofilm from the surface of the teeth.

aPDT + Conventional Treatment Group

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.

Group Type: EXPERIMENTAL

Conventional Treatment

Intervention Type: PROCEDURE

A bicarbonate jet will be used to remove the biofilm from the surface of the teeth.

Antimicrobial Photodynamic Therapy

Intervention Type: PROCEDURE

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.

Interventions

Conventional Treatment

A bicarbonate jet will be used to remove the biofilm from the surface of the teeth.

Intervention Type: PROCEDURE

Antimicrobial Photodynamic Therapy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nove de Julho

OTHER

Sponsor Role: lead

Responsible Party

Marcela Leticia Leal Gonçalves

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 37730405 (View on PubMed)

Other Identifiers

EritroBiofilm

Identifier Type: -

Identifier Source: org_study_id