- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07591948
The Effect of Low-Level Laser Therapy on Accelerating Tooth Movement and Reducing Pain During Orthodontic Treatment (LLLT)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Patients aged 15-30 years requiring fixed orthodontic treatment.
- Extraction treatment plan with bilateral canine retraction.
- Good oral hygiene and periodontal health.
- No systemic diseases or medications affecting bone metabolism.
Exclusion Criteria:
Previous orthodontic treatment.
- Smoking or alcohol consumption.
- Pregnancy or lactation.
- Use of analgesics or anti-inflammatory drugs during the study period.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Sham-komparator: The control group
The control group will receive a sham laser treatment using the same device and procedure as the LLLT group, but without emitting the laser beam.
Both the patients and the operator will be blinded to the treatment allocation
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All participants will receive standard orthodontic treatment using appliances. The type of tooth movement studied will include, (e.g., canine retraction, molar distalization). Orthodontic adjustments will be performed at intervals (e.g., every 4 weeks) by a single calibrated orthodontist to ensure consistency of force application. Force magnitude will be monitored using (e.g., strain gauges, force measuring devices) at each adjustment The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm. The laser parameters will be as follows: Participants receive low-level laser therapy in addition to standard orthodontic treatment. • The laser device used is a Ga-As-Al diode laser with a wavelength of 810 nm, power output of 100 mW, and energy density of 5 J/cm² (Sousa et al., 2011). • Laser application is performed at specific time points: immediately after bracket placement, on days 3, 7, and 14, and then monthly until the end of the study.
Andre navne:
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Aktiv komparator: Laser therapy group
The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm
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All participants will receive standard orthodontic treatment using appliances. The type of tooth movement studied will include, (e.g., canine retraction, molar distalization). Orthodontic adjustments will be performed at intervals (e.g., every 4 weeks) by a single calibrated orthodontist to ensure consistency of force application. Force magnitude will be monitored using (e.g., strain gauges, force measuring devices) at each adjustment The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm. The laser parameters will be as follows: Participants receive low-level laser therapy in addition to standard orthodontic treatment. • The laser device used is a Ga-As-Al diode laser with a wavelength of 810 nm, power output of 100 mW, and energy density of 5 J/cm² (Sousa et al., 2011). • Laser application is performed at specific time points: immediately after bracket placement, on days 3, 7, and 14, and then monthly until the end of the study.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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tooth movement measurement
Tidsramme: Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement. Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using
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Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement.
Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using digital imaging software.
• Parameters: The distance between the canine and second premolar is measured at baseline and at monthly intervals until the end of the study.
• Tool: Digital calipers and specialized software (e.g., OrthoAnalyzer) are used for precise measurements (Ren et al., 2003).
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Tooth Movement Measurement • Method: Cephalometric radiographs will be taken at baseline, 4 weeks, and 8 weeks to assess tooth movement. Linear measurements will be made between specific cephalometric landmarks by a calibrated and blinded examiner using
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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pain assessment
Tidsramme: Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irr
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Pain Assessment • Tool: Visual Analog Scale (VAS) is used to measure pain levels.
• Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irradiation.
• Procedure: Participants mark their pain level on a 10 cm line, where 0 indicates no pain and 10 indicates the worst pain imaginable
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Timing: Pain is assessed at baseline (before treatment) and at 6 hours, 24 hours, 3 days, 7 days, and 14 days after the application of orthodontic force and LLLT/sham irr
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- (OR:06/05/2025)
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