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Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment

15. dubna 2020 aktualizováno: Damascus University

The Effect of Corticision on Perceived Pain and Discomfort for Patients With Crowded Lower Anterior Teeth: Randomized Clinical Trial

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.

Typ studie

Intervenční

Zápis (Aktuální)

26

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Syrská Arabská republika
      • Damascus, Syrská Arabská republika, 00963
        • Orthodontic Department, University of Damascus Dental School

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 24 let (Dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  1. Age range between 18 and 24 years
  2. Completion permanent dentition (except third molars)
  3. Mild to moderate crowding (2-6 mm according to Little's index)
  4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion Criteria:

  1. Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
  2. Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
  3. Patients had previous orthodontic treatments
  4. Poor oral hygiene or concurrent periodontal disease

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Corticision
Patients will undergo a corticision procedure in order to accelerate tooth movement
Postup: Corticision
Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement. Three incisions are going to be made
Aktivní komparátor: Traditional treatment
Patients will undergo traditional orthodontic treatment without any surgical intervention.
Postup: Traditional orthodontic treatment
No surgical intervention will be used, just normal orthodontic sequence of procedures.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in the Perception of Pain
Časové okno: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Pain is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of pain being experienced. The left end of the line refers to no pain (VAS=0) where the right end refers to maximum (unimaginable) pain (VAS=100). The level of pain is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the pain.
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Change in the Perception of Discomfort
Časové okno: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Discomfort is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of discomfort being experienced. The left end of the line refers to no discomfort (VAS=0) where the right end refers to maximum discomfort (VAS=100). The level of discomfort is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the discomfort.
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Change in the Perception of Swelling
Časové okno: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Swelling is assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of swelling being experienced. The left end of the line refers to no swelling (VAS=0) where the right end refers to maximum swelling (VAS=100). The level of swelling is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the swelling
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Change in the Levels of Difficulties in Mastication
Časové okno: At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Difficulties of mastication are assessed by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of difficulties in mastication being experienced. The left end of the line refers to no difficulties (VAS=0) where the right end refers to maximum difficulties (VAS=100). The level of difficulties in mastication is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the difficulties of mastication.
At 24 hours following the onset of treatment (bonding of the appliance), then at 7 days, 14 days following the onset of orthodontic treatment
Analgesic Consumption
Časové okno: The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)
Patients in both groups were asked about taking analgesics and their quantity (mg) They answered about taking analgesics using a two-point scale (1. Yes or 2. No), and their quantity by mentioning how many tablets they took.
The 7th day following the onset of treatment (i.e. at the second visit of the patients following his orthodontic appliance bonding; one-time assessment)

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patients' satisfaction
Časové okno: At the end of leveling and alignment which is expected to occur within 4 to 6 months
Satisfaction is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of satisfaction. The left end of the line refers to no satisfaction (VAS=0) where the right end refers to maximum satisfaction (VAS=100). The level of satisfaction is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the satisfaction.
At the end of leveling and alignment which is expected to occur within 4 to 6 months
Ease of the procedure
Časové okno: At the end of leveling and alignment which is expected to occur within 4 to 6 months
Procedure's easiness is assessed for both groups by asking the study participant to place a mark on a horizontal 100 mm line to indicate the level of ease. The left end of the line refers to no ease (VAS=0) where the right end refers to maximum ease (VAS=100). The grade of ease is represented in the number of millimeters measured from the left end of the line to the mark pointed out by the patient. This is called the Visual Analogue Score (VAS) where the higher the number is the more intense the ease of the procedure.
At the end of leveling and alignment which is expected to occur within 4 to 6 months
The possibility of repeating the procedure
Časové okno: At the end of leveling and alignment which is expected to occur within 4 to 6 months
Patients in the corticision group will be asked about the possibility of repeating the procedure if they had the chance to give their decision again. The answer will be collected using a two-point scale (1. Yes or 2. No).
At the end of leveling and alignment which is expected to occur within 4 to 6 months
Recommendation to a friend
Časové okno: At the end of leveling and alignment which is expected to occur within 4 to 6 months
Patients in the corticision group will be asked about if they would recommend this procedure to a friend. The answer will be collected using a two-point scale (1. Yes or 2. No).
At the end of leveling and alignment which is expected to occur within 4 to 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Damascus University

Vyšetřovatelé

  • Vrchní vyšetřovatel: Mohamad Radwan Sirri, DDS MSc, MSc student in Orthodontics, University of Damascus Dental School
  • Studijní židle: Ahmad S Burhan, DDS MSc PhD, Professor of Orthodontics, University of Damascus, Damascus, Syria
  • Ředitel studie: Mohammad Y Hajeer, DDS MSc PhD, Professor of Orthodontics, University of Damascus Dental School, Damascus, Syria

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

15. března 2017

Primární dokončení (Aktuální)

15. září 2018

Dokončení studie (Aktuální)

15. února 2019

Termíny zápisu do studia

První předloženo

13. dubna 2020

První předloženo, které splnilo kritéria kontroly kvality

15. dubna 2020

První zveřejněno (Aktuální)

16. dubna 2020

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

16. dubna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. dubna 2020

Naposledy ověřeno

1. dubna 2020

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • UDDS-Ortho-03-2020

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

Ne

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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