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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Mohanad Ali Mohammed
- Número de telefone: +9647702797532
- E-mail: Mohannad.ali1203a@codntal.uobaghda.edu.iq
Estude backup de contato
- Nome: Harraa Sabbah Abul ameer
- Número de telefone: +9647904546371
- E-mail: dr.haraa_sabah@codental.uobaghdad.edu.iq
Locais de estudo
-
-
Al-Rusafa
-
Baghdad, Al-Rusafa, Iraque, 0964
- University of Baghdad
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
Aceita Voluntários Saudáveis
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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. |
|
Experimental: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Primary Objectives : Total Treatment Duration.
Prazo: 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).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patient Pain Perception.
Prazo: "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
Prazo: 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
Prazo: 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.
Prazo: 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.
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mohanad Ali Mohammed, University of Baghdad
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1193426
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .