- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07597304
Photobiomodulation Therapy (PBMT) for Accelerating Maxillary Canine Movement Using Two Wavelengths (650 nm and 976 nm): A Split-Mouth Randomized Controlled Clinical Trial (PBMT-CAN)
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Photobiomodulation therapy (PBMT) has been proposed as a non-invasive adjunctive method to accelerate orthodontic tooth movement and reduce overall treatment duration. This split-mouth randomized clinical trial aims to evaluate and compare the effectiveness of two different laser wavelengths (650 nm and 976 nm) on the acceleration of maxillary canine movement during orthodontic treatment.
Participants requiring bilateral maxillary first premolar extraction and canine retraction as part of their orthodontic treatment will be included. Each patient will serve as their own control using a split-mouth design. One side will receive PBMT application during canine retraction, while the contralateral side will act as the control or receive an alternative wavelength according to the randomization protocol.
Orthodontic canine movement will be performed using standardized orthodontic mechanics under controlled force application. The primary outcome measure will be the rate of maxillary canine movement assessed at regular intervals. Secondary outcomes will include total treatment duration required for space closure and the influence of patient-related factors such as age and gender on treatment outcomes.
The study will compare the clinical effectiveness of 650 nm and 976 nm wavelengths in accelerating orthodontic tooth movement. Statistical analyses including paired t-tests, independent t-tests, and correlation analyses will be used to evaluate differences between groups and assess associations between demographic variables and treatment response.
The findings of this study may provide clinically relevant evidence regarding the effectiveness of PBMT in reducing orthodontic treatment time and improving treatment efficiency.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Najaf Governorate
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Najaf, Najaf Governorate, Irak, 54001
- Orthodontic Clinic, College of Dentistry, University of Kufa
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- good oral hygiene and the absence of any medications affecting bone metabolism.
Exclusion Criteria:
- systemic diseases, periodontal pathology, a history of previous orthodontic treatment, or the use of antibiotics or anti-inflammatory drugs during the study.[
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 650 nm PBMT
Participants receive photobiomodulation therapy using a 650 nm laser during maxillary canine retraction.
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Application of 650 nm low-level laser therapy during maxillary canine retraction to accelerate orthodontic tooth movement.
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Eksperimentell: 976 nm PBMT
Participants receive photobiomodulation therapy using a 976 nm laser during maxillary canine retraction.
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Application of 976 nm low-level laser therapy during maxillary canine retraction to accelerate orthodontic tooth movement.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Rate of Maxillary Canine Movement
Tidsramme: 6 months
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Measurement of the amount of maxillary canine movement during orthodontic retraction following application of photobiomodulation therapy using 650 nm and 976 nm wavelengths.
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6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Correlation Between Age and Rate of Canine Retraction
Tidsramme: 6 months
|
Assessment of the correlation between patient age (years) and rate of maxillary canine retraction measured in millimeters per month using digital caliper measurements on study models.
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6 months
|
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Difference in Rate of Canine Retraction Between Sexes
Tidsramme: 6 months
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Comparison of the rate of maxillary canine retraction (mm/month) between male and female participants measured using digital caliper measurements on study models.
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6 months
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Wazwaz F, Seehra J, Carpenter GH, Papageorgiou SN, Cobourne MT. Duration of canine retraction with fixed appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2023 Feb;163(2):154-172. doi: 10.1016/j.ajodo.2022.08.009. Epub 2022 Dec 1.
- Alhumadi A. Gender-related response to different wavelength low-level laser therapy in orthodontic mandibular canine movement: a split-mouth study. Endodontics Today. 2026;24:58-66. doi:10.36377/ET-0159.
- Al-Kufi HM, Alhumadi A, Huthiafa SM. A comparative evaluation of postoperative re-pigmentation following gingival depigmentation using a 940-nm diode laser and abrasion method: a split-mouth study. Lasers in Dental Science. 2024;8(1):3. doi:10.1007/s41547-023-00208-y.
- Zheng J, Yang K. Clinical research: low-level laser therapy in accelerating orthodontic tooth movement. BMC Oral Health. 2021 Jun 28;21(1):324. doi: 10.1186/s12903-021-01684-z.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PBMT-CANINE-2026
- KU-IRB-2026-1-2 (Annen identifikator: Ethics committee number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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