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Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System

4. juni 2026 opdateret af: Mohanad Ali Mohammed, University of Baghdad

Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System : A Randomized Clinical Trial

This study is a multi-center, prospective, parallel-group randomized controlled trial designed to compare the orthodontic treatment outcomes of a passive self-ligating bracket system (Damon Ultima) versus a clear aligner system. The primary objective is to evaluate and compare the total orthodontic treatment duration between the two systems in patients with Angle Class I malocclusion and moderate crowding. Secondary objectives include assessing alignment efficiency, patient pain perception at multiple time intervals, dental arch dimension changes, root volume loss percentage, and overall treatment quality using the American Board of Orthodontics Objective Grading System (ABO-OGS).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Participants aged 17-32 years with full permanent dentition, Class I canine and molar relationships, and moderate crowding (4-8 mm) will be randomly assigned in a 1:1 ratio to either the Damon Ultima group or the Clear Aligner group.

For the Damon Ultima group, brackets will be bonded according to a standardized protocol, utilizing a precise archwire sequence from 0.014-inch CuNiTi up to 0.019x0.0275-inch stainless steel wires. For the Clear Aligner group, patients will be treated with a series of thermoformed removable aligners designed via digital software, with instructions to wear them for 22 hours per day, changing aligners every 2 weeks.

Outcome measurements will include total treatment duration in months, pain perception via a 10-cm Visual Analog Scale (VAS), dental arch changes on 3D digital models, and root resorption via Cone-Beam Computed Tomography (CBCT) radiographs.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Irak
    • Al-Rusafa
      • Baghdad, Al-Rusafa, Irak, 0964
        • University of Baghdad

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
  2. Age range between 16-32 years.
  3. Presence of full permanent dentition except the third molars.
  4. Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
  5. Without previous orthodontic treatment/ functional appliances.

Exclusion Criteria:

  1. Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
  2. Patient with class Ⅱ , Ⅲ malocclusion.
  3. Patient with external or internal root resorption.
  4. Patients with poor oral hygiene or active periodontal disease.
  5. 90o or more degree of tooth rotation.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Self ligating bracket (Damon Ultima)
Patient will be treated with self ligating bracket (Damon Ultima) until dental levelling alignment , crowding resolved and case will be finished
Enhed: self ligating bracket

Teeth will be bonded with Damon Ultima® bracket system by the same protocol of bonding for all patients with the same bonding materials, time and curing apparatus by highly filled light-cure adhesive (Enlight, Ormco Corp., Glendora, California, USA). Archwire sequence will be: 0.014-inch CuNiTi, 0.018-inch CuNiTi, 0.014×0.0275-inch CuNiTi, 0.018×0.0275-inch CuNiTi archwires and 0.019×0.0275-inch stainless steel Ultima finishing archwires if needed.

Appointment intervals will be 6-8 weeks for treatment mechanics, including use of inter-arch elastics, bite raiser, and finishing procedures will be standardized. All patients will receive oral hygiene instructions at each visit. In case of bracket failure, brackets will be rebonded using the same system within 24 hours, otherwise the case would be considered as dropout.
Eksperimentel: Clear aligner system
Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished
Enhed: Clear aligner

a series of invisible thermoformed removable aligners after designed by software and delivered to patients after the digital scanning of the initial models.

A series of nearly invisible appliances to incrementally move the teeth from their crowded initial position to their final straightened position, these subjects will instructed to wear each aligner 22 hours a day, 7 days a week . The anterior teeth will be reduce at each interproximal location by means of diamond-coated finishing strips used for interproximal reduction , in case of debond attachment should be bonded within 24 hours.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Primary Objectives : Total Treatment Duration.
Tidsramme: From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).
The total time required to complete the orthodontic treatment from the day of appliance bonding/delivery to the day of debonding/treatment completion.
From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Patient Pain Perception.
Tidsramme: "Baseline (Day 1), and at 6 hours, 24 hours, 3 days, and 7 days following the initial appliance insertion and after each subsequent archwire activation or aligner change throughout the active treatment phase, up to 14 months."

Changes in pain levels scored by patients using a Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "severe, unbearable pain".

Units on a scale (0-10).
"Baseline (Day 1), and at 6 hours, 24 hours, 3 days, and 7 days following the initial appliance insertion and after each subsequent archwire activation or aligner change throughout the active treatment phase, up to 14 months."
Dental Arch Alignment Efficiency
Tidsramme: Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.
Assessment of dental crowding reduction measured on 3D digital models using Little's Irregularity Index (LII) Unit of Measure: Millimeters (mm).
Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.
Changes in Dental Arch Dimensions
Tidsramme: Baseline (Day 1) and through study completion, an average of 14 months

Measurement of dental arch length, arch perimeter, and transverse widths (inter-canine, inter-premolar, and inter-molar widths) on 3D digital models.

Unit of Measure: Millimeters (mm).
Baseline (Day 1) and through study completion, an average of 14 months
Root Volume Loss Percentage.
Tidsramme: Baseline (Day 1) and through study completion, an average of 14 months

Evaluation of external apical root resorption and volume loss percentage of the teeth calculated via Cone-Beam Computed Tomography (CBCT).

Unit of Measure: Percentage (%).
Baseline (Day 1) and through study completion, an average of 14 months
Objective Grading System Score.
Tidsramme: Through study completion, an average of 14 months

Evaluation of the final orthodontic treatment outcome quality using the American Board of Orthodontics Objective Grading System (ABO-OGS) on digital models.

Unit of Measure: Points/Score.
Through study completion, an average of 14 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Baghdad

Efterforskere

  • Ledende efterforsker: Mohanad Ali Mohammed, University of Baghdad

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

15. maj 2026

Primær færdiggørelse (Anslået)

20. november 2027

Studieafslutning (Anslået)

20. august 2028

Datoer for studieregistrering

Først indsendt

27. april 2026

Først indsendt, der opfyldte QC-kriterier

4. juni 2026

Først opslået (Faktiske)

10. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 1193426

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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Kliniske forsøg med Dental Crowding

Kliniske forsøg med self ligating bracket

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Placeringer

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