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- Essai clinique NCT07591948
The Effect of Low-Level Laser Therapy on Accelerating Tooth Movement and Reducing Pain During Orthodontic Treatment (LLLT)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur factice: 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.
Autres noms:
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Comparateur actif: Laser therapy group
The LLLT group will receive laser treatment using a Ga-As-Al diode laser operating at a wavelength of 810 nm
|
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.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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tooth movement measurement
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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pain assessment
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- (OR:06/05/2025)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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