The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients

NCT06331442 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-26

No results posted yet for this study

Summary

This randomized controlled trial will be conducted on 40 orthodontic patients at the Department of Orthodontics, University Hospital Centre Zagreb, Croatia. Respondents will be randomly allocated into 4 groups (n=10). The first group will receive photodynamic therapy, the second tricalcium phosphate varnish with 5% NaF (sodium fluoride), the third 1% chlorhexidine varnish, while the fourth group will be the negative control. Before and after the mentioned interventions, the participants will have the amount of plaque measured using the plaque index and the bacteriological composition of the plaque assessed using the mass spectrometry and PCR. The gingival condition will be assessed using the gingival index. Also, the occurrence of white spot lesions will be evaluated on intraoral photographs.

Conditions

  • Plaque, Dental
  • Dental Plaque Induced Gingivitis
  • White Spot Lesion

Interventions

OTHER

Photodynamic therapy

Patients allocated to the first group (n=10) will receive photodynamic therapy. Buccal/labial surface around the bracket of each tooth in the upper dental arch (from right to left second premolar) will be treated with toluidine blue based dye (155 mg/mL; LaserHF Paro-PDT, Hager \& Werken, GmbH \& Co. Kg, Duisburg, Germany). This photosensitive solution will be applied on teeth with the sterile syringe and left for 60 s. Then, the excess of the photosensitive solution will be rinsed with the sterile syringe containing a saline solution. Then, a 660 nm diode laser (Laser HF, Hager \& Werken, GmbH \& Co. Kg, Duisburg, Germany) will be used for photoactivation (power output 100 mW, power density 124.34 W/cm2 and continuous working mode). Buccal/labial surface of each tooth will be radiated for 60 s at approximately 5 mm away from the enamel surface. This intervention will be performed right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later.

OTHER

Tricalcium phosphate (TCP) varnish with 5% NaF

Tricalcium phosphate varnish with 5% NaF (Clinpro™ White Varnish, 3M ESPE 3M Deutschland GmbH, Germany) will be applied to the patients allocated to the second group (n=10). The varnish will be applied to the buccal/labial surfaces of 10 teeth in the upper dental arch (from right to left second premolar) according to the manufacturer's recommendations. This intervention will be performed right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later.

OTHER

Chlorhexidine varnish

Chlorhexidine varnish (1% CHX, 1% thymol; Cervitec® Plus, Ivoclar Vivadent AG, Schaan, Liechtenstein) will be applied to the patients allocated to the third group (n=10). The varnish will be applied to the buccal/labial surfaces of 10 teeth in the upper dental arch (from right to left second premolar) according to the manufacturer's recommendations. This intervention will be performed right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later.

Sponsors & Collaborators

  • University of Zagreb

    lead OTHER

Principal Investigators

  • Tadeja Blagec, DMD · University of Zagreb

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2024-11-30
Completion
2024-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331442 on ClinicalTrials.gov