- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT02977221
Efficacy of Piezosurgey Corticotomy (a Minimally Invasive Surgical Technique) in Accelerating Orthodontic Alignment
Evaluation of the Efficacy of Flapless Corticotomy Accomplished by Piezosurgery in Accelerating Orthodontic Treatment of Crowding in Adults: a Randomized Controlled Trial
Přehled studie
Detailní popis
According to the American Association of Orthodontists (AAO), the length of comprehensive orthodontic treatment ranges between 18-30 months, depending on treatment options and individual characteristics. In addition, orthodontic treatment time ranges between 25-35 months for extraction therapies, respectively. Reducing orthodontic treatment time is one of the main goals for orthodontists, due to problems such as root resorption, periodontal disease and caries that are associated with prolonged treatment time.
Many techniques have been introduced to accelerate orthodontic tooth movement; surgical and non-surgical. The surgical approach is the most clinically applied and most tested with known predictions and stable results. Surgical approaches usually vary from total block osteotomies to flapless partial corticotomies .In spite of corticotomy-assisted orthodontic treatment efficiency, the invasiveness of these procedures (i.e. requiring full mucoperiosteal flaps elevation) might have limited their widespread acceptance among orthodontists and patients. Therefore, more conservative flapless corticotomy techniques have recently been proposed. These procedures can be accomplished in a reasonably short periods that might produce less pain and discomfort, so we will gain better patient acceptance. Although various techniques of flapless corticotomy have been reported to be successful in practice, scientific evidence for their effectiveness so far has been limited to case series and a few clinical trials, generally with small groups. This study aims to provide some evidence about the efficacy of piezosurgery in a flapless technique to align crowded lower anterior teeth using a parallel-group randomized controlled trial study design.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Damascus, Syrská Arabská republika, DM20AM18
- Departments of Orthodontics and Oral and Maxillofcial Surgery, University of Damascus Dental School
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Adult healthy patients , Male and female, Age range: 15-27 years.
- Severe crowding ≤ 7 (Little's irregularity index)
- Permanent occlusion.
- Exist all the Mandibular teeth (except third molars).
Good oral and periodontal health:
- Probing depth<4 mm
- No radiographic evidence of bone loss .
- Gingival index≤ 1
- Plaque index ≤ 1
Exclusion Criteria:
- Medical problems that affect tooth movement (corticosteroid, NSAIDs, …)
- Patients have anti indication for oral surgery ( medical - social - psycho)
- Presence of primary teeth in the mandibular arch
- Missing permanent mandibular teeth (except third molars).
Poor oral hygiene or Current periodontal disease:
- Probing depth ≥ 4 mm
- radiographic evidence of bone loss
- Gingival index > 1
- Plaque index > 1
- Patient had previous orthodontic treatment
Studijní plán
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 |
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Experimentální: Piezosurgery
Piezosurgery will be performed on the anterior lower segment of the dental arch in order to accelerate the correction of mandibular anterior crowding.
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The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth.
Ostatní jména:
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Žádný zásah: Ordinary Alignment
Treatment will be provided to the patients without any surgical interventions.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Duration of tooth alignment
Časové okno: This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
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This outcome will be measured in 'days'.
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This will be measured at the end of treatment by calculating the time required time (in days) to achieve complete alignment of lower anterior teeth from the first day of treatment and up to 120-150 days of observation
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Change in Tooth Alignment at one month
Časové okno: Little Index of Irregularity will be measured at 30 days after the onset of treatment.
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This index is measured on plaster study casts of patients' teeth.
The value obtained will be compared to the value obtained at the beginning of treatment.
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Little Index of Irregularity will be measured at 30 days after the onset of treatment.
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Change in Tooth Alignment at two months
Časové okno: Little Index of Irregularity will be measured at 60 days after the onset of treatment.
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This index is measured on plaster study casts of patients' teeth.
The value obtained will be compared to the value obtained at the beginning of treatment.
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Little Index of Irregularity will be measured at 60 days after the onset of treatment.
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Change in Tooth Alignment at last assessment time
Časové okno: Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
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This index is measured on plaster study casts of patients' teeth.
The value obtained will be compared to the value obtained at the beginning of treatment.
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Little Index of Irregularity will be measured when a complete alignment is achieved; this is expected between 90 to 120 days after the onset of treatment.
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Omar Gibreal, DDS, MSc student, Oral and Maxillofacial Surgery Department, University of Damascus Dental School
- Ředitel studie: Bassel Brad, DDS MSc PhD, Associate Professor of Oral and Maxillofacial Surgery, Department of Oral and Maxillofacial Surgery, Univ. of Damascus Dental School
- Ředitel studie: Mohammad Y Hajeer, DDS MSc PhD, Associate Professor of Orthodontics, Department of Orthodontics, University of Damascus Dental School
Publikace a užitečné odkazy
Obecné publikace
- Sebaoun JD, Surmenian J, Dibart S. [Accelerated orthodontic treatment with piezocision: a mini-invasive alternative to conventional corticotomies]. Orthod Fr. 2011 Dec;82(4):311-9. doi: 10.1051/orthodfr/2011142. Epub 2011 Nov 23. French.
- Vercellotti T, Podesta A. Orthodontic microsurgery: a new surgically guided technique for dental movement. Int J Periodontics Restorative Dent. 2007 Aug;27(4):325-31.
- Keser EI, Dibart S. Sequential piezocision: a novel approach to accelerated orthodontic treatment. Am J Orthod Dentofacial Orthop. 2013 Dec;144(6):879-89. doi: 10.1016/j.ajodo.2012.12.014.
- Gibreal O, Hajeer MY, Brad B. Efficacy of piezocision-based flapless corticotomy in the orthodontic correction of severely crowded lower anterior teeth: a randomized controlled trial. Eur J Orthod. 2019 Mar 29;41(2):188-195. doi: 10.1093/ejo/cjy042.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- UDDS-OMFS-01-2016
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
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