- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne 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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Ankara, Turcja (Türkiye), 06560
- Ankara University, Faculty of Dentistry, Department of Orthodontics
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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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Aktywny komparator: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Mean Bilateral Masseter Muscle Activity at Rest
Ramy czasowe: 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
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Change in Mean Bilateral Anterior Digastric Muscle Activity During Maximum Voluntary Clenching
Ramy czasowe: Baseline (T0), 1 month (T2), and 6 months (T3).
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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
Ramy czasowe: 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
Ramy czasowe: 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).
|
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Change in Mean Bilateral Anterior Temporalis Muscle Activity at Rest
Ramy czasowe: 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).
|
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Change in Mean Bilateral Masseter Muscle Activity During Maximum Voluntary Clenching
Ramy czasowe: 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).
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Change in Overbite
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Ayşe T Altuğ Demiralp, DDS, PhD, Professor, Ankara University Faculty of Dentistry Department of Orthodontics
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2025-755
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
There is currently no plan to share individual participant data with other researchers.
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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