Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System : A Randomized Clinical Trial
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Mohanad Ali Mohammed
- Puhelinnumero: +9647702797532
- Sähköposti: Mohannad.ali1203a@codntal.uobaghda.edu.iq
Tutki yhteystietojen varmuuskopiointi
- Nimi: Harraa Sabbah Abul ameer
- Puhelinnumero: +9647904546371
- Sähköposti: dr.haraa_sabah@codental.uobaghdad.edu.iq
Opiskelupaikat
-
-
Al-Rusafa
-
Baghdad, Al-Rusafa, Irak, 0964
- University of Baghdad
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
Inclusion Criteria:
- Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
- Age range between 16-32 years.
- Presence of full permanent dentition except the third molars.
- Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
- Without previous orthodontic treatment/ functional appliances.
Exclusion Criteria:
- Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
- Patient with class Ⅱ , Ⅲ malocclusion.
- Patient with external or internal root resorption.
- Patients with poor oral hygiene or active periodontal disease.
- 90o or more degree of tooth rotation.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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
|
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. |
|
Kokeellinen: Clear aligner system
Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished
|
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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Primary Objectives : Total Treatment Duration.
Aikaikkuna: 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).
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Patient Pain Perception.
Aikaikkuna: "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
Aikaikkuna: 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
Aikaikkuna: 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.
Aikaikkuna: 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.
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Mohanad Ali Mohammed, University of Baghdad
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 1193426
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .