- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
-
-
Najaf Governorate
-
Najaf, Najaf Governorate, Irak, 54001
- Orthodontic Clinic, College of Dentistry, University of Kufa
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
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.[
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
Experimenteel: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Rate of Maxillary Canine Movement
Tijdsspanne: 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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Correlation Between Age and Rate of Canine Retraction
Tijdsspanne: 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
Tijdsspanne: 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
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PBMT-CANINE-2026
- KU-IRB-2026-1-2 (Andere identificatie: Ethics committee number)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .