Bracket Positioning Techniques and Quality of Orthodontic Finishing
10 juli 2026 bijgewerkt door: Hager Mansour Abdelbaseer Zoghby, Future University in Egypt
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
This three-arm randomized clinical trial compares three orthodontic bracket positioning techniques - Smile Arc Protection (SAP), Smile Arc and Marginal Ridge Approach (SAMRA), and the McLaughlin-Bennett-Trevisi (MBT) bracket placement chart (control) - in young patients with Angle Class I malocclusion and mild-to-moderate crowding treated non-extraction.
The primary aim is to determine which technique yields the highest quality of orthodontic finishing, measured with the American Board of Orthodontics Objective Grading System (ABO-OGS).
Secondary aims compare anterior tooth tip and torque (assessed by CBCT) and mini-esthetic smile parameters (gingival display, incisal display, buccal corridor, and smile arc, assessed on standardized posed-smile photographs) among the three techniques.
Studie Overzicht
Toestand
Voltooid
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
39
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Cairo Governorate
-
New Cairo, Cairo Governorate, Egypte, 11835
- Department of Orthodontics, Faculty of Oral and Dental Medicine, Future University in Egypt, Cairo, Egypt
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Nee
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Group SAP
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
|
Bracket positioning by the Smile Arc Protection technique (anterior brackets placed relatively more gingival, referenced to canine crown height).
|
|
Experimenteel: Group SAMRA
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
|
Bracket positioning by the Smile Arc and Marginal Ridge Approach (digital workflow referencing the marginal-ridge line and facial axis).
|
|
Actieve vergelijker: Group MBT (Control)
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
|
Bracket positioning by the McLaughlin-Bennett-Trevisi bracket placement chart (bracket-to-incisal-edge distances from the standardized chart).
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Quality of orthodontic finishing - ABO Objective Grading System (ABO-OGS) total score
Tijdsspanne: 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.
|
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).
|
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.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Anterior crown angulation (tip) - CBCT
Tijdsspanne: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
Change in mesiodistal crown angulation (tip) of the anterior teeth, measured in degrees on dentoalveolar CBCT using defined landmarks and reference planes.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Anterior crown inclination (torque) - CBCT
Tijdsspanne: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
Change in labiolingual crown inclination (torque) of the anterior teeth, measured in degrees on dentoalveolar CBCT.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Maxillary gingival display
Tijdsspanne: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Maxillary incisal display
Tijdsspanne: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Buccal corridor width
Tijdsspanne: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
|
Smile arc category
Tijdsspanne: Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
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.
|
Change from before bonding (T₀) to end of levelling and alignment (T₁), approximately 7 months after bonding
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 juli 2024
Primaire voltooiing (Werkelijk)
1 juli 2026
Studie voltooiing (Werkelijk)
1 juli 2026
Studieregistratiedata
Eerst ingediend
7 juli 2026
Eerst ingediend dat voldeed aan de QC-criteria
10 juli 2026
Eerst geplaatst (Werkelijk)
16 juli 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
16 juli 2026
Laatste update ingediend die voldeed aan QC-criteria
10 juli 2026
Laatst geverifieerd
1 juli 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- FUE.REC(42)/10-2024
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Beschrijving IPD-plan
Study data are stored confidentially within the Department of Orthodontics with access restricted to the investigator and supervisors; results will be disseminated through the institutional thesis repository and peer-reviewed publication.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .