- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07708363
Bracket Positioning Techniques and Quality of Orthodontic Finishing
Comparison of Three Bracket Positioning Techniques (Smile Arc Protection, Smile Arc and Marginal Ridge Approach, and McLaughlin-Bennett-Trevisi) on the Quality of Orthodontic Finishing, Mini-Esthetics, and Anterior Tooth Tip and Torque: A Three-Arm Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Bracket positioning is one of the most influential operator-dependent factors affecting the quality of orthodontic finishing and the resulting smile esthetics. Three contemporary positioning philosophies are compared in this trial.
Design. Eligible participants are randomly allocated 1:1:1 to one of three parallel arms. Allocation is generated with an online randomizer, concealed in sequentially opaque sealed envelopes held by a co-supervisor, and revealed only on the day of intervention. Outcome assessors are blinded; operator blinding is not feasible.
Intervention. All arms receive a fully digital indirect-bonding workflow (intraoral scanning, virtual bracket placement in 3Shape Ortho-Analyzer, 3D-printed casts, vacuum-formed transfer trays) using a 0.018-inch MBT prescription, and an identical arch wire sequence ending in a 0.017 in × 0.025 in stainless steel wire maintained for three months. The arms differ only in the vertical/angular bracket-positioning rule applied (SAP, SAMRA, or MBT chart).
Assessment. Records are captured before bonding (T₀) and at the end of levelling and alignment (T₁). The ABO-OGS is scored on 3D-printed casts and the panoramic radiograph; tip and torque are measured on dentoalveolar CBCT; mini-esthetic parameters are measured on standardized frontal posed-smile photographs calibrated in Adobe Photoshop.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Cairo Governorate
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New Cairo, Cairo Governorate, Egypten, 11835
- Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Males and females aged 14-25 years with a full permanent dentition.
- Mild to moderate crowding requiring non-extraction orthodontic treatment (2-6 mm per Graber's classification).
- Angle Class I malocclusion.
- Normal skeletal vertical dimension (SN-MP angle 32° ± 5°).
Exclusion Criteria:
1. Medication that may cause gingival inflammation (e.g., cyclosporine, phenytoin).
2. Impacted, extracted, or missing permanent teeth (except third molars). 3. Periodontal disease or parafunctional habits (bruxism, tongue thrusting, mouth breathing).
4. History of previous orthodontic treatment. 5. Craniofacial anomalies, facial asymmetry, or skeletal discrepancy.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group SAP
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
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Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
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Eksperimentel: Group SAMRA
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
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Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
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Aktiv komparator: Group MBT (Control)
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
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Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
Tidsramme: At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
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Total ABO-OGS score obtained on the Cast-Radiographic Evaluation (CRE) form.
Seven parameters - alignment/rotations, marginal ridges, buccolingual inclination, occlusal contacts, occlusal relationships, overjet, and interproximal contacts - are scored on 3D-printed casts with the ABO measuring gauge; root angulation is scored on the panoramic radiograph.
Point deductions are summed to give the total score (a lower total indicates better finishing).
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At completion of the levelling and alignment phase (T₁), after the 0.017 in × 0.025 in stainless steel arch wire has been maintained for 3 months - approximately 7 months after bonding.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Anterior crown angulation (tip) - CBCT
Tidsramme: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in mesiodistal crown angulation (tip) of the anterior teeth, measured in degrees on dentoalveolar CBCT using defined landmarks and reference planes.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Anterior crown inclination (torque) - CBCT
Tidsramme: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in labiolingual crown inclination (torque) of the anterior teeth, measured in degrees on dentoalveolar CBCT.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Maxillary gingival display
Tidsramme: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in maxillary gingival display - the vertical distance (mm) between the inferior border of the upper lip and the gingival zenith of each maxillary anterior tooth (central incisor, lateral incisor, canine, both sides) on standardized posed-smile frontal photographs, measured in Adobe Photoshop after calibration against a metric ruler.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Maxillary incisal display
Tidsramme: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in maxillary incisal display - the vertical amount (mm) of maxillary incisor crown visible relative to the upper lip during a posed smile, on standardized photographs.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Buccal corridor width
Tidsramme: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Change in buccal corridor (lateral negative space) - the linear distance (mm) between the most posterior visible maxillary tooth and the corner of the mouth during posed smile, measured on each side and averaged.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Smile arc category
Tidsramme: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Smile arc classified as consonant, flat, or reversed based on the relationship between the curvature of the maxillary incisal/canine/premolar edges and the curvature of the lower lip during posed smile.
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Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- FUE.REC(42)/10-2024
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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