The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients

NCT06331442 | Not Yet Recruiting

• 1 other identifier: 006503905
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

dental plaque; gingiva; white spot lesion; photodynamic therapy; chlorhexidine varnish; tricalcium phosphate varnish; fluoride

Outcome Measures

Primary Outcomes (2)

• Assessment of dental plaque accumulation using plaque index

  In T0, plaque accumulation on upper 10 teeth (from right to left second premolar) will be measured using Silness and Löe plaque index. In T1, T2 and T3 the accumulation of plaque will be measured using the modified Silness and Löe plaque index. The plaque index will be measured on the upper 10 teeth (from right to left second premolar). The tooth surface around the bracket will be divided into 4 areas - mesial, distal, gingival and occlusal. In each area, the level of plaque will be expressed on a scale from 0 to 3: 0- no dentobacterial plaque; 1- flecks of dentobacterial plaque; 2- continuous line of dentobacterial plaque≤1 mm; 3- continuous line of dentobacterial plaque\>1 mm. Plaque index will be measured before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3).

  18 weeks

• Assessment of the bacteriological composition of supragingival plaque using mass spectrometry

  A sample of supragingival plaque will be taken from all 10 examined teeth in the upper dental arch using a sterile probe. The sample will be stored in an Eppendorf plastic tube containing 1.5 mL of physiological solution. From the solution, 0.01 μL of the sample will be inoculated onto blood/Brucella and Columbia agar and incubated aerobically and anaerobically. After incubation, visible bacterial colonies will be counted in CFU (colony forming units) and identified by the MALDI-TOF (matrix assisted laser desorption/ionization) method. A sample for microbiological analysis will be taken before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3).

  18 weeks

Secondary Outcomes (3)

• Assessment of the bacteriological composition of subgingival plaque using polymerase chain reaction

  18 weeks

• Assessment of gingival condition using gingival index

  18 weeks

• Diagnosis of white spot lesions on intraoral photographs

  18 weeks

Study Arms (4)

Photodynamic therapy group

EXPERIMENTAL

Group of participants (n=10) allocated to this group will receive photodynamic therapy which consists of toluidine blue based dye (155 mg/mL) and 660 nm diode laser. Participants will be subjected to this treatment right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later.

Other: Photodynamic therapy

Tricalcium phosphate varnish with 5% NaF group

ACTIVE COMPARATOR

Group of participants (n=10) allocated to this group will receive tricalcium varnish with 5% NaF which will be applied according to the manufacturer's recommendations. Participants will be subjected to this treatment 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

Chlorhexidine varnish group

ACTIVE COMPARATOR

Group of participants (n=10) allocated to this group will receive chlorhexidine varnish which will be applied according to the manufacturer's recommendations. Participants will be subjected to this treatment right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later.

Other: Chlorhexidine varnish

Negative control group

NO INTERVENTION

Group of participants (n=10) allocated to this group will not receive an intervention.

Interventions

Photodynamic therapy OTHER

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.

Photodynamic therapy group

Tricalcium phosphate (TCP) varnish with 5% NaF OTHER

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.

Tricalcium phosphate varnish with 5% NaF group

Chlorhexidine varnish OTHER

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.

Chlorhexidine varnish group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• to 17 years of age
• indication for fixed orthodontic treatment without the need for extraction
• permanent dentition (including second molars)
• absence of oral lesions, caries, pulpal and periapical diseases and gingival and periodontal diseases

You may not qualify if:

• previous orthodontic treatment
• taking antibiotics and anti-inflammatory drugs 3 months before the study and during the study
• use of antiseptic rinses 3 months before the study and during the study
• taking corticosteroids and immunosuppressive drugs
• smoking
• systemic conditions that can affect the inflammatory response of soft tissues and the possibility of maintaining adequate plaque control (diabetes, immune disorders, etc.)

Sponsors & Collaborators

• University of Zagreb: lead

Related Publications (1)

• Blagec T, Simunovic L, Budimir A, Gabric D, Mestrovic S. The influence of photodynamic therapy on the supragingival plaque accumulation and bacterial composition in orthodontic patients: a randomized controlled trial. Eur J Orthod. 2025 Sep 17;47(5):cjaf072. doi: 10.1093/ejo/cjaf072.

  PMID: 41091662 DERIVED

MeSH Terms

Conditions

Dental Plaque

Interventions

Photochemotherapy; tricalcium phosphate; tenocyclidine; Paint

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Tadeja Blagec, DMD

  University of Zagreb

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tadeja Blagec, DMD

CONTACT

003851 4802 163; tblagec@sfzg.hr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Dental Medicine

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: March 26, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2024
• Study Completion: November 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03