- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07744685
Root Shortening With Three Methods of Upper Front Teeth Retraction
External Apical Root Resorption in Three Miniscrew-Supported Maxillary En-Masse Retraction Mechanics: A Randomized Controlled Trial
Przegląd badań
Status
Warunki
Szczegółowy opis
Orthodontic camouflage treatment of adult patients with Class II Division 1 malocclusion frequently involves extraction of the maxillary first premolars followed by retraction of the upper anterior teeth. Temporary orthodontic miniscrews can provide skeletal anchorage during this stage and allow the six maxillary anterior teeth to be retracted together as one unit. Although these mechanics are widely used, the anterior teeth remain exposed to orthodontic forces during both the initial leveling and alignment phase and the subsequent retraction phase. External apical root resorption is therefore an important biological safety outcome that should be evaluated throughout treatment rather than only after space closure has been completed.
This single-center, three-arm, parallel-group randomized clinical trial was conducted at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Sixty adult patients with Class II Division 1 malocclusion who required extraction-based orthodontic camouflage treatment were allocated equally to one of three treatment groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group.
The three approaches differed in the relationship between the anterior brackets and the working archwire. The bidimensional approach used smaller anterior bracket slots with larger posterior slots. The hybrid dual-section approach used a customized archwire with different anterior and posterior cross-sections, while the conventional group used a continuous archwire with a uniform cross-section. These mechanical differences may influence archwire engagement, force expression, and the distribution of forces applied to the roots of the maxillary anterior teeth. Their possible effect on external apical root resorption therefore required direct clinical comparison.
All participants underwent bilateral extraction of the maxillary first premolars, fixed-appliance leveling and alignment, and miniscrew-supported en-masse retraction of the six maxillary anterior teeth. The same general treatment stages and skeletal anchorage concept were used in all groups, while the bracket-slot and archwire configurations varied according to group allocation. Retraction continued until an acceptable overjet and a Class I canine relationship were achieved. Participants were reviewed regularly throughout treatment, and miniscrew-related or other treatment-associated adverse events were recorded.
Digital panoramic radiographs were obtained before orthodontic treatment, at the end of leveling and alignment immediately before retraction, and after completion of en-masse retraction. The maxillary central incisors, lateral incisors, and canines on both sides were assessed individually. Crown length was used as a stable reference to correct for differences in radiographic magnification between time points.
The study was designed to determine whether the three treatment approaches were associated with different amounts of external apical root resorption and to identify the treatment phase during which root shortening occurred. Resorption was therefore evaluated separately during leveling and alignment, during en-masse retraction, and across the complete observation period. This phase-specific design was intended to avoid attributing all root changes detected at the end of retraction to the retraction mechanics alone.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Damascus, Syria, DM20AM19
- Faculty of Dentistry
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged 18-30 years.
- Class II Division 1 dental malocclusion according to Angle classification
- Mild-to-moderate skeletal Class II discrepancy, with an ANB angle greater than 4° and not exceeding 7°.
- Overjet ranging from 5 to 9 mm.
- Presence of all six maxillary anterior teeth.
- Maxillary anterior teeth fully erupted and with complete root formation.
Exclusion Criteria:
- Patients with previous orthodontic treatment.
- Missing permanent maxillary teeth.
- Active periodontal disease.
- History of trauma to any maxillary anterior tooth.
- Previous endodontic treatment of any maxillary anterior tooth.
- Periapical pathology involving any maxillary anterior tooth.
- Extensive coronal restorations that could interfere with crown-length measurement.
- Radiographic evidence of pre-existing root resorption before orthodontic treatment.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Bidimensional Bracket Group
Participants will be treated using a bidimensional fixed orthodontic appliance during leveling, alignment, and en-masse retraction.
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Fixed orthodontic treatment will be performed using 0.018-inch slot brackets from canine to canine and 0.022-inch slot brackets on the posterior teeth.
After leveling and alignment, en-masse retraction will be performed on a 0.018 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side.
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Eksperymentalny: Hybrid Dual-Section Archwire Group
Participants will be treated using a hybrid dual-section archwire during miniscrew-supported en-masse retraction.
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Fixed orthodontic treatment will be performed using 0.022-inch slot brackets.
En-masse retraction will be carried out using a customized stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior section and 0.016 × 0.022-inch posterior sections, with the transitions located distal to the maxillary canines.
Bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g per side will be used.
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Aktywny komparator: Conventional Sliding Mechanics Group
Participants will be treated using conventional fixed orthodontic sliding mechanics during miniscrew-supported en-masse retraction
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Fixed orthodontic treatment will be performed using 0.022-inch slot brackets.
En-masse retraction will be carried out on a continuous 0.019 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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External Apical Root Resorption of the Maxillary Anterior Teeth
Ramy czasowe: Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 12 months.
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External apical root resorption was assessed separately for the six maxillary anterior teeth by measuring changes in corrected root length on digital panoramic radiographs using ImageJ software.
Crown length was used as a stable reference to correct for differences in radiographic magnification.
Root resorption was expressed in millimeters, and the total amount was calculated directly from the initial and final radiographs rather than by adding the interval measurements.
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Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 12 months.
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Mohammad Younis Hajeer, Department of Orthodontics, Faculty of Dentistry, University of Damascus
- Główny śledczy: Abdulmalek M. H. Almasri, Department of Orthodontics, Faculty of Dentistry, University of Damascus
Publikacje i pomocne linki
Publikacje ogólne
- Linge BO, Linge L. Apical root resorption in upper anterior teeth. Eur J Orthod. 1983 Aug;5(3):173-83. doi: 10.1093/ejo/5.3.173. No abstract available.
- Levander E, Malmgren O. Evaluation of the risk of root resorption during orthodontic treatment: a study of upper incisors. Eur J Orthod. 1988 Feb;10(1):30-8. doi: 10.1093/ejo/10.1.30. No abstract available.
- Futyma-Gabka K, Rozylo-Kalinowska I, Piskorz M, Bis E, Borek W. Evaluation of root resorption in maxillary anterior teeth during orthodontic treatment with a fixed appliance based on panoramic radiographs. Pol J Radiol. 2022 Oct 5;87:e545-e548. doi: 10.5114/pjr.2022.120512. eCollection 2022.
- Dudic A, Giannopoulou C, Leuzinger M, Kiliaridis S. Detection of apical root resorption after orthodontic treatment by using panoramic radiography and cone-beam computed tomography of super-high resolution. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):434-7. doi: 10.1016/j.ajodo.2008.10.014.
- Artun J, Smale I, Behbehani F, Doppel D, Van't Hof M, Kuijpers-Jagtman AM. Apical root resorption six and 12 months after initiation of fixed orthodontic appliance therapy. Angle Orthod. 2005 Nov;75(6):919-26. doi: 10.1043/0003-3219(2005)75[919:ARRSAM]2.0.CO;2.
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
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- UDDS-2026-Ortho-03
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