Modified Versus Clear Twin Block for Skeletal Class II Malocclusion (MTB-CTB)
Evaluation of the Efficacy of Functional Therapy Using Modified Twin Block Versus Clear Twin Block in Class II Skeletal Patients: A Randomized Controlled Clinical Trial
This study aims to evaluate the effectiveness of a modified Twin Block appliance compared to a conventional clear Twin Block appliance in the treatment of skeletal Class II malocclusion caused by mandibular retrusion in growing patients.
This is a two-arm randomized controlled clinical trial including patients aged 10-13 years diagnosed with skeletal Class II malocclusion. Participants will be randomly allocated into two equal groups.
Skeletal, dental, and soft tissue changes will be assessed using lateral cephalometric analysis and cone-beam computed tomography (CBCT). Additionally, temporomandibular joint (TMJ) health, pain perception, and functional tolerance will be evaluated using standardized clinical indices and patient-reported outcome measures.
The study aims to compare the modified appliance with the conventional design in terms of skeletal improvement, TMJ safety, and patient acceptance.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Skeletal and dentofacial anomalies, particularly Class II malocclusion due to mandibular retrusion, represent one of the most prevalent orthodontic problems during growth. Functional appliances, especially the Twin Block appliance, are widely used to enhance mandibular development and correct jaw discrepancies. However, variations in treatment protocols, particularly regarding advancement mechanics and appliance modifications, may influence both skeletal outcomes and temporomandibular joint (TMJ) response.
This study aims to investigate the effects of a modified Twin Block appliance, incorporating progressive mandibular advancement and additional design modifications such as lower lip pads intended to influence muscular activity, compared to a conventional clear Twin Block appliance.
A two-arm randomized controlled trial will be conducted on growing patients aged 10-13 years diagnosed with skeletal Class II malocclusion due to mandibular retrusion. Participants will be randomly allocated into two equal groups using a computer-generated randomization sequence with allocation concealment.
Skeletal and dental changes will be evaluated using lateral cephalometric radiographs and cone-beam computed tomography (CBCT), with particular attention to condylar morphology, joint space dimensions, and craniofacial skeletal relationships. TMJ health will be assessed using the Helkimo Index. Patient comfort, pain perception, and functional adaptation will be evaluated using validated questionnaires administered at multiple time points throughout the treatment period.
Radiographic and clinical assessments will be performed at baseline (T0) and after 7 months of functional appliance therapy (T1). Repeated patient-reported outcome measures will be collected at predefined intervals during treatment.
The objective of this study is to determine whether the modified Twin Block appliance provides superior skeletal and functional outcomes while maintaining temporomandibular joint safety and improving patient tolerance compared to the conventional appliance.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Aleppo Governorate
-
Aleppo, Aleppo Governorate, Siria
- Faculty of Dentistry, University of Aleppo
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Systemically healthy patients.
- Patients willing to accept removable functional appliance therapy.
- Skeletal Class II malocclusion (Angle Class II Division 1).
- Skeletal Class II due to mandibular retrusion (ANB ≥ 5°, 6 mm ≤ OJ ≤ 13 mm , SNB ≤ 78°, with normal maxillary position).
- Growth stage corresponding to MP3 stage or pre-pubertal peak according to hand-wrist radiograph (Björk and Helm, 1967).
- No severe dental crowding in the dental arches and no significant maxillary dental protrusion.
- Absence of congenital anomalies, trauma, burns, or surgical scars affecting the temporomandibular joint or craniofacial structures.
- Absence of systemic or rheumatologic diseases affecting the temporomandibular joint.
Exclusion Criteria:
- Presence of clinical signs or symptoms of temporomandibular joint disorders.
- Functional mandibular deviation.
- Previous orthodontic treatment.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Modified Twin Block Group
Patients in this group will be treated using a modified Twin Block appliance incorporating progressive mandibular advancement and lower lip pads designed to influence muscular activity and enhance skeletal effects.
|
A modified Twin Block functional appliance incorporating progressive mandibular advancement and lower lip pads designed to modify muscular activity and enhance mandibular growth.
The appliance is used for the treatment of skeletal Class II malocclusion due to mandibular retrusion in growing patients.
Otros nombres:
|
|
Comparador activo: Conventional Clear Twin Block Group
Patients in this group will be treated using a conventional clear Twin Block functional appliance for correction of skeletal Class II malocclusion.
|
A conventional clear Twin Block functional appliance used for correction of skeletal Class II malocclusion in growing patients.
The appliance acts by posturing the mandible forward to stimulate functional and skeletal adaptation.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in mandibular skeletal position measured by SNB angle on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of sagittal mandibular skeletal position using the SNB angle (degrees) measured on standardized lateral cephalometric radiographs.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in effective mandibular length measured by Co-Gn distance on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of mandibular length using the Condylion-Gnathion (Co-Gn) linear measurement in millimeters obtained from lateral cephalometric analysis.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in condylar dimensions assessed using cone-beam computed tomography (CBCT)
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of temporomandibular condylar morphology using CBCT, including condylar length, condylar width, and condylar height measured in millimeters.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in temporomandibular joint spaces assessed using CBCT
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of condylar position within the glenoid fossa using CBCT measurements of anterior joint space (AJS), superior joint space (SJS), posterior joint space (PJS), and medial joint space (MJS), measured in millimeters.
|
Baseline (T0) and after 7 months of treatment (T1)
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Temporomandibular joint dysfunction symptoms assessed using the Helkimo Anamnestic Index (Ai)
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of temporomandibular joint dysfunction symptoms using the Helkimo Anamnestic Index questionnaire. The index classifies patients into:
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Patient-reported pain intensity assessed using a Numeric Rating Scale (NRS)
Periodo de tiempo: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months after appliance insertion
|
Assessment of pain intensity reported by patients using a numeric rating scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates maximum pain.
|
1 week, 2 weeks, 6 weeks, 3 months, and 6 months after appliance insertion
|
|
Patient-reported discomfort and functional limitation assessed using a validated questionnaire
Periodo de tiempo: 1 week, 2 weeks, 6 weeks, 3 months, and 6 months after appliance insertion
|
Assessment of appliance-related discomfort and functional or social impairment using a validated questionnaire adapted from Sergl and Zentner (1998), modified by Idris et al. (2012).
The questionnaire evaluates pressure sensation, tooth sensitivity, speech impairment, swallowing difficulty, mouth restriction sensation, and social confidence using a numeric rating scale from 0 to 10. Higher scores indicate greater discomfort and poorer appliance acceptance.
|
1 week, 2 weeks, 6 weeks, 3 months, and 6 months after appliance insertion
|
|
Change in lower incisor inclination measured by IMPA on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of lower incisor inclination using the Incisor Mandibular Plane Angle (IMPA) measured in degrees on lateral cephalometric radiographs.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in upper incisor inclination measured by U1-SN angle on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of upper incisor inclination using the upper incisor to SN plane angle (U1-SN) measured in degrees on lateral cephalometric radiographs.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in overjet measured on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of overjet as the horizontal distance between upper and lower incisors measured in millimeters on lateral cephalometric radiographs.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in overbite measured on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of overbite as the vertical overlap between upper and lower incisors measured in millimeters on lateral cephalometric radiographs.
|
Baseline (T0) and after 7 months of treatment (T1)
|
|
Change in sagittal molar relationship measured on lateral cephalometric radiographs
Periodo de tiempo: Baseline (T0) and after 7 months of treatment (T1)
|
Assessment of sagittal molar relationship using linear measurements in millimeters between upper and lower first molars on lateral cephalometric radiographs.
|
Baseline (T0) and after 7 months of treatment (T1)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Abdulmalek Majanni, PhD, Faculty of Dentistry, University of Aleppo
Publicaciones y enlaces útiles
Publicaciones Generales
- Wu Y, Yu Q, Xia Y, Wang B, Chen S, Gu K, Zhang B, Zhu M. Does mandibular advancement with clear aligners have the same skeletal and dentoalveolar effects as traditional functional appliances? BMC Oral Health. 2023 Feb 2;23(1):65. doi: 10.1186/s12903-023-02709-5.
- Lombardo EC, Lione R, Franchi L, Gaffuri F, Maspero C, Cozza P, Pavoni C. Dentoskeletal effects of clear aligner vs twin block-a short-term study of functional appliances. J Orofac Orthop. 2024 Sep;85(5):317-326. doi: 10.1007/s00056-022-00443-1. Epub 2023 Jan 18.
- Caruso S, Nota A, Caruso S, Severino M, Gatto R, Meuli S, Mattei A, Tecco S. Mandibular advancement with clear aligners in the treatment of skeletal Class II. A retrospective controlled study. Eur J Paediatr Dent. 2021;22(1):26-30. doi: 10.23804/ejpd.2021.22.01.05.
- Tripathi T, Singh N, Rai P, Gupta P. Comparison of Dentoskeletal Changes, Esthetic, and Functional Efficacy of Conventional and Novel Esthetic Twin Block Appliances among Class II Growing Patients: A Pilot Study. Turk J Orthod. 2020 Jun 1;33(2):77-84. doi: 10.5152/TurkJOrthod.2020.19030. eCollection 2020 Jun.
- Golfeshan F, Soltani MK, Zohrei A, Poorolajal J. Comparison between Classic Twin-block and a Modified Clear Twin-block in Class II, Division 1 Malocclusions: A Randomized Clinical Trial. J Contemp Dent Pract. 2018 Dec 1;19(12):1455-1462.
- Gill DS, Lee RT. Prospective clinical trial comparing the effects of conventional Twin-block and mini-block appliances: Part 1. Hard tissue changes. Am J Orthod Dentofacial Orthop. 2005 Apr;127(4):465-72; quiz 517. doi: 10.1016/j.ajodo.2004.11.012.
- Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. doi: 10.1016/j.ajodo.2004.03.024.
- Kyburz KS, Eliades T, Papageorgiou SN. What effect does functional appliance treatment have on the temporomandibular joint? A systematic review with meta-analysis. Prog Orthod. 2019 Aug 12;20(1):32. doi: 10.1186/s40510-019-0286-9.
- Chadwick SM, Banks P, Wright JL. The use of myofunctional appliances in the UK: a survey of British orthodontists. Dent Update. 1998 Sep;25(7):302-8.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MClearTB
- UADS-3478-26052024/SRC-1994 (Otro identificador: University of Aleppo Local Ethics Committee)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .