- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07851948
Effects of Anterior Bite Turbos on Deep Bite Treatment and Chewing Muscles
Evaluation of the Effects of Anterior Bite Turbo Application During Deep Bite Treatment on Dentoalveolar and Skeletal Structures and Masticatory Muscles
This study evaluated how anterior bite turbos used during orthodontic treatment of deep bite affect chewing muscle activity and dental and skeletal measurements. Participants were followed in two nonrandomized groups: one received anterior bite turbos as part of orthodontic treatment, and the other received orthodontic treatment without bite turbos. Surface electromyography (EMG) was used to measure muscle activity over time. Cephalometric measurements were also evaluated to assess treatment-related changes.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
This prospective, nonrandomized, two-group study examined patients undergoing orthodontic treatment for deep bite. Anterior bite turbos were applied in one group; the comparison group underwent orthodontic treatment without anterior bite turbos during the study period.
Surface EMG recordings of the right and left masseter, anterior temporalis, and anterior digastric muscles were obtained at rest and during maximum voluntary clenching. Both groups were assessed before treatment, at approximately one month, and at approximately six months. The bite turbo group also underwent an EMG assessment immediately after bite turbo placement. Cephalometric measurements were evaluated at baseline and approximately six months.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Ankara, Turecko (Türkiye), 06560
- Ankara University, Faculty of Dentistry, Department of Orthodontics
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Permanent dentition.
- Angle Class I or Class II malocclusion.
- Mild to moderate dental crowding (≤6 mm).
- Non-extraction fixed orthodontic treatment planned.
- No missing teeth, excluding third molars.
- For the anterior bite turbo group: increased overbite (>4 mm).
- For the control group: normal anterior overbite (2-3 mm).
Exclusion Criteria:
- Bruxism or other oral parafunctional habits.
- Temporomandibular joint disorder.
- Craniofacial asymmetry, craniofacial syndrome, or cleft lip and/or palate.
- Dental anomalies, including missing teeth other than third molars or abnormalities of tooth shape.
- Previous orthodontic or myofunctional treatment.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Anterior Bite Turbo Group
Participants received anterior bite turbos as part of fixed orthodontic treatment for deep bite. Surface EMG and orthodontic measurements were obtained during follow-up. |
Composite resin bite turbos were bonded to the palatal surfaces of the maxillary central incisors during fixed orthodontic treatment. The bite turbos were used to disclude the posterior teeth during deep bite treatment. Participants received fixed orthodontic treatment for deep bite. |
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Aktivní komparátor: No Bite Turbo Group
Participants received fixed orthodontic treatment without anterior bite turbos during the study period. Surface EMG and orthodontic measurements were obtained during follow-up. |
Participants received fixed orthodontic treatment for deep bite. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Mean Bilateral Masseter Muscle Activity at Rest
Časové okno: Baseline (before bite turbo placement), 1 month, and 6 months
|
Surface electromyographic activity of the right and left masseter muscles was recorded at rest. The mean of the two sides, measured in microvolts (µV), was evaluated at baseline, 1 month, and 6 months. Changes over time were compared between the anterior bite turbo and no bite turbo groups. |
Baseline (before bite turbo placement), 1 month, and 6 months
|
|
Change in Mean Bilateral Anterior Digastric Muscle Activity During Maximum Voluntary Clenching
Časové okno: Baseline (T0), 1 month (T2), and 6 months (T3).
|
Surface EMG amplitude of the right and left anterior digastric muscles during maximum voluntary clenching was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups. |
Baseline (T0), 1 month (T2), and 6 months (T3).
|
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Change in Mean Bilateral Anterior Digastric Muscle Activity at Rest
Časové okno: Baseline (T0), 1 month (T2), and 6 months (T3).
|
Surface EMG amplitude of the right and left anterior digastric muscles at rest was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups. |
Baseline (T0), 1 month (T2), and 6 months (T3).
|
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Change in Mean Bilateral Anterior Temporalis Muscle Activity During Maximum Voluntary Clenching
Časové okno: Baseline (T0), 1 month (T2), and 6 months (T3).
|
Surface EMG amplitude of the right and left anterior temporalis muscles during maximum voluntary clenching was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups. |
Baseline (T0), 1 month (T2), and 6 months (T3).
|
|
Change in Mean Bilateral Anterior Temporalis Muscle Activity at Rest
Časové okno: Baseline (T0), 1 month (T2), and 6 months (T3).
|
Surface EMG amplitude of the right and left anterior temporalis muscles at rest was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups. |
Baseline (T0), 1 month (T2), and 6 months (T3).
|
|
Change in Mean Bilateral Masseter Muscle Activity During Maximum Voluntary Clenching
Časové okno: Baseline (T0), 1 month (T2), and 6 months (T3).
|
Surface EMG amplitude of the right and left masseter muscles during maximum voluntary clenching was averaged for each participant and measured in microvolts (µV). Change over time was compared between groups. |
Baseline (T0), 1 month (T2), and 6 months (T3).
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Overbite
Časové okno: Baseline and 6 months.
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Vertical overlap of the maxillary and mandibular central incisors was measured on lateral cephalograms in millimeters (mm). Change from baseline to 6 months was compared between groups. |
Baseline and 6 months.
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Change in Overjet
Časové okno: Baseline and 6 months.
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Horizontal distance between the maxillary and mandibular central incisors was measured on lateral cephalograms in millimeters (mm). Change was compared between groups. |
Baseline and 6 months.
|
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Change in SN-GoGn Angle
Časové okno: Baseline and 6 months.
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The angle between the Sella-Nasion and mandibular planes was measured on lateral cephalograms in degrees. Change was compared between groups. |
Baseline and 6 months.
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Change in Overbite
Časové okno: Baseline and 6 months.
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The distance from anterior nasal spine to Menton was measured on lateral cephalograms in millimeters (mm). Change was compared between groups. |
Baseline and 6 months.
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Change in ANB Angle
Časové okno: Baseline and 6 months.
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The A point-Nasion-B point angle was measured on lateral cephalograms in degrees. Change was compared between groups. |
Baseline and 6 months.
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Change in Upper Incisor to NA Distance
Časové okno: Baseline and 6 months.
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The linear distance from the maxillary central incisor to the Nasion-A point line was measured in millimeters (mm). Change was compared between groups. |
Baseline and 6 months.
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Change in Upper Incisor to NA Angle
Časové okno: Baseline and 6 months.
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The angle between the maxillary central incisor long axis and the Nasion-A point line was measured in degrees. Change was compared between groups. |
Baseline and 6 months.
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Change in IMPA
Časové okno: Baseline and 6 months.
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The angle between the mandibular central incisor long axis and mandibular plane was measured in degrees. Change was compared between groups. |
Baseline and 6 months.
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Change in Interincisal Angle
Časové okno: Baseline and 6 months
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The angle between the long axes of the maxillary and mandibular central incisors was measured in degrees. Change was compared between groups. |
Baseline and 6 months
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Change in Upper Lip to S Line Distance
Časové okno: Baseline and 6 months
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The distance from the upper lip to Steiner's S line was measured in millimeters (mm). Change was compared between groups. |
Baseline and 6 months
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Change in Lower Lip to S Line Distance
Časové okno: Baseline and 6 months
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The distance from the lower lip to Steiner's S line was measured in millimeters (mm). Change was compared between groups. |
Baseline and 6 months
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ayşe T Altuğ Demiralp, DDS, PhD, Professor, Ankara University Faculty of Dentistry Department of Orthodontics
Publikace a užitečné odkazy
Obecné publikace
- Al-Zoubi EM, Al-Nimri KS. A comparative study between the effect of reverse curve of Spee archwires and anterior bite turbos in the treatment of deep overbite cases. Angle Orthod. 2022 Jan 1;92(1):36-44. doi: 10.2319/020921-117.1.
- Wasinwasukul P, Nalamliang N, Pairatchawan N, Thongudomporn U. Effects of anterior bite planes fabricated from acrylic resin and thermoplastic material on masticatory muscle responses and maximum bite force in children with a deep bite: A 6-month randomised controlled trial. J Oral Rehabil. 2022 Oct;49(10):980-992. doi: 10.1111/joor.13351. Epub 2022 Jul 3.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2025-755
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
There is currently no plan to share individual participant data with other researchers.
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