- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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)
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Najaf Governorate
-
Najaf, Najaf Governorate, Irak, 54001
- Orthodontic Clinic, College of Dentistry, University of Kufa
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 650 nm PBMT
Participants receive photobiomodulation therapy using a 650 nm laser during maxillary canine retraction.
|
Application of 650 nm low-level laser therapy during maxillary canine retraction to accelerate orthodontic tooth movement.
|
|
Experimentell: 976 nm PBMT
Participants receive photobiomodulation therapy using a 976 nm laser during maxillary canine retraction.
|
Application of 976 nm low-level laser therapy during maxillary canine retraction to accelerate orthodontic tooth movement.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Rate of Maxillary Canine Movement
Tidsram: 6 months
|
Measurement of the amount of maxillary canine movement during orthodontic retraction following application of photobiomodulation therapy using 650 nm and 976 nm wavelengths.
|
6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation Between Age and Rate of Canine Retraction
Tidsram: 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.
|
6 months
|
|
Difference in Rate of Canine Retraction Between Sexes
Tidsram: 6 months
|
Comparison of the rate of maxillary canine retraction (mm/month) between male and female participants measured using digital caliper measurements on study models.
|
6 months
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- PBMT-CANINE-2026
- KU-IRB-2026-1-2 (Annan identifierare: Ethics committee number)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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