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- Klinische proef NCT07739498
Posterior Resin Bite Turbos Effect on Maxillary Expansion Using a HYRAX Expander in Early Adolescents (HYRAX_ RME_SME)
Effect of Posterior Disarticulatory Resin Bite Turbos on the Rate of Maxillary Expansion Using HYRAX Expander in Early Adolescent Patients: Randomized Controlled Clinical Trial
Studie Overzicht
Toestand
Gedetailleerde beschrijving
This study is conducted as part of a Master's thesis in Orthodontics and aims to investigate the influence of posterior disarticulatory resin bite turbos on the rate of maxillary expansion achieved using a HYRAX expander in early adolescent patients.
The study evaluates whether modifying occlusal contacts can affect skeletal and dental responses during rapid maxillary expansion.
Participants will be monitored clinically throughout the expansion phase.
Participants will be assigned in two groups:
group 1: with posterior bite turbos group 2: without posterior bite turbos
Digital intraoral scans will be taken on a weekly basis to assess changes in maxillary dimensions and to accurately measure the rate and pattern of expansion over time.
These serial digital records provide high-resolution, non-invasive documentation of treatment progress.
CBCT will be taken before the expansion and after retention phase for skeletal and dental measurement .
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Donia Alashker
- Telefoonnummer: 00201557372170
- E-mail: donyaalashker7@mans.edu.eg
Studie Locaties
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Al Mansurah, Egypte
- Werving
- Orthodontic Department - Faculty of Dentistry Mansoura University
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Contact:
- Faculty of Dentistry Mansoura University
- Telefoonnummer: 0020502267151
- E-mail: dentfac@mansoura.edu.eg
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patients aged 10-14 years.
- Bilateral posterior cross bite.
- Functional lateral cross bite.
- Good general and oral health.
- Normal to decreased vertical height )average FMA 29.7 °± 4.2 °).23
Exclusion Criteria:
- Patients with cleft lip and palate.
- Severe facial asymmetry.
- Anterior open bite.
- Systemic conditions affecting tooth movement (e.g., diabetes, bone disorders).
- Previous orthodontic treatment.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: group 1: HYRAX with posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos.
The bite turbos are placed on posterior teeth to achieve occlusal disclusion, aiming to minimize occlusal interference during expansion and potentially enhance skeletal response.
The HYRAX expander is activated according to a standardized protocol throughout the treatment period, with regular follow-up using clinical assessment and weekly intraoral scans.
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Description: Arm 1: Participants in this group receive a HYRAX rapid maxillary expansion appliance combined with posterior disarticulatory resin bite turbos. The bite turbos are placed on the posterior teeth to disclude the occlusion, aiming to reduce occlusal interference and potentially enhance skeletal response during maxillary expansion. The HYRAX appliance is activated according to a standardized expansion protocol. |
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Actieve vergelijker: Group 2 : Expansion without posterior bite turbos
Participants in this arm receive a HYRAX rapid maxillary expansion appliance without the use of posterior disarticulatory resin bite turbos.
The appliance is activated according to a standardized expansion protocol similar to the experimental group.
Patients are followed throughout the treatment period with regular clinical assessments and weekly intraoral scans to monitor changes in maxillary dimensions.
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Participants in this group receive a HYRAX rapid maxillary expansion appliance alone without the use of posterior bite turbos.
The appliance is activated following the same standardized expansion protocol as the intervention group.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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The effect of occlusal disarticulation on the rate of maxillary expansion by linear measurements made on digital models
Tijdsspanne: Baseline and weekly during the active phase of expansion and after 3 months of retention
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Dental landmarks and measurements on models : d3 :Canine tip. d4: Central fissure of first premolar. d6 :Central fissure of first permanent molar. d_3( inter canine width): Distance between left and right d3. d_4 (inter first premolar width) : Distance between left and right d4. d_6(inter first molar width): Distance between left and right d6. |
Baseline and weekly during the active phase of expansion and after 3 months of retention
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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-The effect of the posterior disarticulation on alveolar bone changes by CBCT .
Tijdsspanne: baseline and after three months of retention after complete active expansion
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Skeletal transverse, vertical, nasal width changes and axial inclination of posterior teeth will be evaluated .
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baseline and after three months of retention after complete active expansion
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pain felt by the patient after activating the expansion screw
Tijdsspanne: first two weeks in active phase of expansion
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ain will be assessed using the Visual Analogue Scale (VAS), a 100 mm line with "no pain" at the left end and "the worst unbearable pain" at the right, which corresponds to a pain score between 0 and 10.
All participants will be asked to place a vertical mark indicating the level of pain on the VAS 4 h after each activation for the first two weeks in diary sheet containing the actual size of a 100mm of VAS. 25
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first two weeks in active phase of expansion
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Donia Alashker, Faculty of Dentistry Mansoura University
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- MS.26.02.145
Plan Individuele Deelnemersgegevens (IPD)
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