Plaque, DentalNCT06331442
The Effect of Photodynamic Therapy on Plaque in Orthodontic Patients
A study testing Photodynamic therapy, Tricalcium phosphate (TCP) varnish with 5% NaF and Chlorhexidine varnish in people with Plaque, Dental and Dental Plaque Induced Gingivitis, run by University of Zagreb.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental, Dental Plaque Induced Gingivitis, White Spot Lesion
- What is being tested?
- Photodynamic therapy, Tricalcium phosphate (TCP) varnish with 5% NaF and Chlorhexidine varnish
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Nov 2024
- Phase
- Interventional
- 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 12 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
Who cannot join
- 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.)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Photodynamic Therapy on Accumulation and Bacteriological Composition of Dental Plaque in Orthodontic Patients
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.
Read the detailed description
Goals of this research are: 1. To compare the plaque index in orthodontic patients treated with different antibacterial agents (photodynamic therapy, tricalcium phosphate varnish with 5% NaF, chlorhexidine varnish) before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3); 2. To compare the bacteriological composition of supragingival plaque using the mass spectrometry in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3); 3. To compare the bacteriological composition of subgingival plaque using polymerase chain reaction in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0) and 18 weeks later (T3); 4. To compare the gingival index in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3); 5. To compare the occurrence of white spot lesions in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0) and 18 weeks later (T3).
This study hypothesizes that photodynamic therapy is just as effective in reducing plaque accumulation, reducing bacteria in supragingival and subgingival plaque, preventing gingival inflammation and preventing initial carious lesions (white spot lesions) in orthodontic patients as tricalcium phosphate varnish with 5% NaF and 1% chlorhexidine varnish.
Participants (40 orthodontic patients at the Department of Orthodontics, University Hospital Centre Zagreb, Croatia) will be randomly assigned to one of four groups. Randomization will be performed before the recruitment using software for randomization (Research Randomizer; permuted blocks randomization). Outcome assessor will be blinded, while participants and care providers will be aware of the group allocation.
Group of participants (n=10) allocated to the first group will receive photodynamic therapy which consists of toluidine blue based dye (155 mg/mL) and 660 nm diode laser. Participants (n=10) allocated to the second group will receive tricalcium varnish with 5% NaF which will be applied according to the manufacturer's recommendations. Group of participants (n=10) allocated to the third group will receive chlorhexidine varnish which will be applied according to the manufacturer's recommendations. All interventions will be performed right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later. The fourth group (n=10) will be the negative control which means that participants will not receive any intervention.
Primary outcome measures: assessment of dental plaque accumulation using plaque index and assessment of the bacteriological composition of supragingival plaque using mass spectrometry. Secondary outcome measures: assessment of the bacteriological composition of subgingival plaque using the polymerase chain reaction, assessment of gingival condition using the gingival index and diagnosis of white spot lesions on intraoral photographs.
- Being tested
- Photodynamic therapy, Tricalcium phosphate (TCP) varnish with 5% NaF, Chlorhexidine varnish
- Keywords
- dental plaque, gingiva, white spot lesion, photodynamic therapy, chlorhexidine varnish, tricalcium phosphate varnish, fluoride
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photodynamic therapyOther
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.
Tricalcium phosphate (TCP) varnish with 5% NaFOther
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.
Chlorhexidine varnishOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Chlorhexidine varnish |
| Negative control group | No intervention | Group of participants (n=10) allocated to this group will not receive an intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 18 weeks
Secondary outcomes (3)
Assessment of the bacteriological composition of subgingival plaque using polymerase chain reaction
A sample of subgingival plaque will be taken from the gingival sulcus of all 10 examined teeth in the upper dental arch using sterile paper points (#50). The paper point will be placed in the gingival sulcus up to 4 mm or until resistance is felt and left for 20-30 seconds. After that, the paper point with the sample will be placed in an Eppendorf plastic tube containing 1.5 mL of physiological solution and will be stored at -80 ℃. The samples will then be analyzed by the molecular method- polymerase chain reaction. Primers will be used to detect the following bacteria: Aggregatibacter actynomicetemcomitans, Porphyromonas gingivalis, Porphyromonas endodontalis, Treponema denticola, Tannerella forsythia and Fusobacterium nucleatum. A sample for molecular analysis will be taken before insertion of a fixed orthodontic appliance (T0) and 18 weeks later (T3).
Measured: 18 weeks
Assessment of gingival condition using gingival index
The gingival condition will be assessed using Silness and Löe gingival index on 10 teeth in the upper dental arch (from right to left second premolar). The soft tissue around the tooth will be divided into 4 parts/areas: distolabial/buccal papilla, labial marginal gingiva, mesiolabial/buccal papilla, and palatal marginal gingiva. In each area, inflammation of the gingiva will be expressed on a scale from 0 to 3, as follows: 0- normal gingiva; 1- mild inflammation- slight change in color, slight oedema, no bleeding on probing; 2- moderate inflammation- redness, oedema and glazing, bleeding on probing; 3- severe inflammation- marked redness and oedema, ulceration, tendency to spontaneous bleeding. Gingival index will be measured before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3).
Measured: 18 weeks
Diagnosis of white spot lesions on intraoral photographs
The labial surfaces of 10 teeth in the upper dental arch (from right to left second premolar) will be photographed. Intraoral photographs (frontal, left and right sagittal) will be taken using a camera (Nikon digital camera d7500, Nikon, Tokio, Japan) at settings ISO=125, f=32. The photos taken in the first and last visit will be placed next to each other on the monitor and compared. An identical white spot lesion on photographs taken at T0 and T3 (same size and surface) will be considered a developmental or fluoride white spot. A white spot that was present at T0 but worsened (enlarged spot or changed surface) over time will be recorded as a white spot lesion. Photographs will be taken before insertion of a fixed orthodontic appliance (T0) and 18 weeks later (T3).
Measured: 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (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 Plaque, DentalStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tadeja Blagec, University of Zagreb
- Investigators
- Tadeja Blagec, DMD, Principal investigator, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06331442
- Sponsor's protocol ID
- 006503905
- Status last verified
- Mar 2024
- First submitted
- 19 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41091662
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Photodynamic Therapy on Accumulation and Bacteriological Composition of Dental Plaque in Orthodontic Patients
- ClinicalTrials.gov ID
- NCT06331442
- Acronym / sponsor ID
- 006503905
- Keywords
- dental plaque, gingiva, white spot lesion, photodynamic therapy, chlorhexidine varnish, tricalcium phosphate varnish, fluoride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 26 Mar 2024 (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 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.
Detailed description
Goals of this research are: 1. To compare the plaque index in orthodontic patients treated with different antibacterial agents (photodynamic therapy, tricalcium phosphate varnish with 5% NaF, chlorhexidine varnish) before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3); 2. To compare the bacteriological composition of supragingival plaque using the mass spectrometry in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3); 3. To compare the bacteriological composition of subgingival plaque using polymerase chain reaction in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0) and 18 weeks later (T3); 4. To compare the gingival index in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0), 6 weeks (T1), 12 weeks (T2) and 18 weeks later (T3); 5. To compare the occurrence of white spot lesions in orthodontic patients treated with different antibacterial agents before insertion of a fixed orthodontic appliance (T0) and 18 weeks later (T3).
This study hypothesizes that photodynamic therapy is just as effective in reducing plaque accumulation, reducing bacteria in supragingival and subgingival plaque, preventing gingival inflammation and preventing initial carious lesions (white spot lesions) in orthodontic patients as tricalcium phosphate varnish with 5% NaF and 1% chlorhexidine varnish.
Participants (40 orthodontic patients at the Department of Orthodontics, University Hospital Centre Zagreb, Croatia) will be randomly assigned to one of four groups. Randomization will be performed before the recruitment using software for randomization (Research Randomizer; permuted blocks randomization). Outcome assessor will be blinded, while participants and care providers will be aware of the group allocation.
Group of participants (n=10) allocated to the first group will receive photodynamic therapy which consists of toluidine blue based dye (155 mg/mL) and 660 nm diode laser. Participants (n=10) allocated to the second group will receive tricalcium varnish with 5% NaF which will be applied according to the manufacturer's recommendations. Group of participants (n=10) allocated to the third group will receive chlorhexidine varnish which will be applied according to the manufacturer's recommendations. All interventions will be performed right after the placement of a fixed orthodontic appliance (T0), 6 weeks (T1) and 12 weeks (T2) later. The fourth group (n=10) will be the negative control which means that participants will not receive any intervention.
Primary outcome measures: assessment of dental plaque accumulation using plaque index and assessment of the bacteriological composition of supragingival plaque using mass spectrometry. Secondary outcome measures: assessment of the bacteriological composition of subgingival plaque using the polymerase chain reaction, assessment of gingival condition using the gingival index and diagnosis of white spot lesions on intraoral photographs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Photodynamic therapy group | Experimental | Other: Photodynamic therapyGroup 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. |
| Tricalcium phosphate varnish with 5% NaF group | Active comparator | Other: Tricalcium phosphate (TCP) varnish with 5% NaFGroup 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. |
| Chlorhexidine varnish group | Active comparator | Other: Chlorhexidine varnishGroup 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. |
| Negative control group | No intervention | –Group of participants (n=10) allocated to this group will not receive an intervention. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 12 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Photodynamic therapyPatients 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 | Photodynamic therapy group |
| Tricalcium phosphate (TCP) varnish with 5% NaFTricalcium 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 | Tricalcium phosphate varnish with 5% NaF group |
| Chlorhexidine varnishChlorhexidine 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. | Other | Chlorhexidine varnish group |
Primary outcome
Assessment of dental plaque accumulation using plaque index
Time frame: 18 weeks
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).
Assessment of the bacteriological composition of supragingival plaque using mass spectrometry
Time frame: 18 weeks
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).
3 secondary outcomes
Assessment of the bacteriological composition of subgingival plaque using polymerase chain reaction
Time frame: 18 weeks
Assessment of gingival condition using gingival index
Time frame: 18 weeks
Diagnosis of white spot lesions on intraoral photographs
Time frame: 18 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Derived from this study: PubMed 41091662Blagec 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.
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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.
Tadeja Blagec, DMD principal investigator
University of Zagreb
Questions about this trial
What is this clinical trial studying?
A study testing Photodynamic therapy, Tricalcium phosphate (TCP) varnish with 5% NaF and Chlorhexidine varnish in people with Plaque, Dental and Dental Plaque Induced Gingivitis, run by University of Zagreb.
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 4 inclusion and 6 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 26 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tadeja Blagec, DMD (003851 4802 163, tblagec@sfzg.hr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of dental plaque accumulation using plaque index (time frame: 18 weeks). The study lists 2 primary outcomes in all. 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 NCT06331442, 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 26 Mar 2024.