- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02209818
Effect of Laser Application in Pain Management Following the Use of Orthodontic Elastomeric Separators
Evaluation of Low Level Laser Therapy (LLLT) Effect on Pain Management Caused by Orthodontic Elastomeric Separators
The aim of this study is to evaluate the effect of low level laser therapy (LLLT) on pain management in people commencing orthodontic treatment. The study design is a randomized controlled trial.
Participants' pain will be dealt with by laser irradiation in one side of the jaw randomly, and the other side will be treated by a placebo procedure. Pain assessment will be measured using Visual Analog Scales (VAS).
The hypothesis of this study is that laser irradiation decreases the amount of pain following the insertion of orthodontic separators.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Here we have two groups:
The first group will undergo one dose of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).
The second group will undergo two doses of irradiation which is going to be applied on one side of the mouth whereas the opposing side will serve as a control side (placebo).
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Damascus, Syrien Arabiske Republik, DM20AM18
- Department of Periodontics, University of Damascus Dental School
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Participants should have healthy periodontal structures, healthy teeth.
- Presence of first molar in both side of the jaw.
Exclusion Criteria:
- systemic diseases
- chronic pain or neurological pain
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Laser Irradiation One Dose
Laser irradiation will be applied in one dose for patients in this group, but only on one side of the jaw.
The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).
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Eksperimentel: Laser Irradiation Two doses
Laser irradiation will be applied in two doses for patients in this group, but only on one side of the jaw.
The second dose will be given after 24 hour of the first one.
The other side of the jaw will receive a placebo procedure (i.e. a red light beam will be emitted on the gingival tissues as if they are irradiated by a laser beam).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Pain Perception
Tidsramme: Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation
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Pain assessment will be performed using a Visual Analog Scale (VAS).
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Pain will be evaluated at 1, 6, 24, 48, and 72 hours after laser irradiation
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Mai Almallah, DDS, MSc student, Department of Periodontics, University of Damascus Dental School, Damascus
- Studieleder: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor, Orthodontics Department, University of Damascus Dental School, Damascus
- Studieleder: Wael Mahdi, DDS MSc PhD, Senior Lecturer in Periodontics, Periodontics Department, University of Damascus Dental School
Publikationer og nyttige links
Generelle publikationer
- Artes-Ribas M, Arnabat-Dominguez J, Puigdollers A. Analgesic effect of a low-level laser therapy (830 nm) in early orthodontic treatment. Lasers Med Sci. 2013 Jan;28(1):335-41. doi: 10.1007/s10103-012-1135-y. Epub 2012 Jul 21.
- Kim WT, Bayome M, Park JB, Park JH, Baek SH, Kook YA. Effect of frequent laser irradiation on orthodontic pain. A single-blind randomized clinical trial. Angle Orthod. 2013 Jul;83(4):611-6. doi: 10.2319/082012-665.1. Epub 2012 Dec 14.
- Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.
- Abtahi SM, Mousavi SA, Shafaee H, Tanbakuchi B. Effect of low-level laser therapy on dental pain induced by separator force in orthodontic treatment. Dent Res J (Isfahan). 2013 Sep;10(5):647-51.
- Eslamian L, Borzabadi-Farahani A, Hassanzadeh-Azhiri A, Badiee MR, Fekrazad R. The effect of 810-nm low-level laser therapy on pain caused by orthodontic elastomeric separators. Lasers Med Sci. 2014 Mar;29(2):559-64. doi: 10.1007/s10103-012-1258-1. Epub 2013 Jan 20.
- Huang TH, Liu SL, Chen CL, Shie MY, Kao CT. Low-level laser effects on simulated orthodontic tension side periodontal ligament cells. Photomed Laser Surg. 2013 Feb;31(2):72-7. doi: 10.1089/pho.2012.3359. Epub 2013 Jan 17.
- Fujiyama K, Deguchi T, Murakami T, Fujii A, Kushima K, Takano-Yamamoto T. Clinical effect of CO(2) laser in reducing pain in orthodontics. Angle Orthod. 2008 Mar;78(2):299-303. doi: 10.2319/033007-153.1.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- UDDS-Perio-06-2014
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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