Comparative Evaluation of Mandibular Advancement Using different Clear Aligner Systems compared with Conventional Functional Appliance in A Controlled Clinical trial

Comparative Evaluation of Skeletal, Dentoalveolar, Occlusal, Three Dimensional, and Patient Reported Outcomes Following Mandibular Advancement Using Angelalign A6, Invisalign Mandibular Advancement, and Twin Block Appliance in Growing Patients with Skeletal Class II Malocclusion: A Prospective Controlled Clinical Study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

TCTR

Registry ID

TCTR20260520003

Enrollment

110

Registered

2026-05-20

Start date

2026-05-06

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic malocclusion requiring mandibular advancement therapy Skeletal Class II malocclusion Mandibular advancement Clear aligners Angelalign A6 Invisalign Mandibular Advancement Twin Block appliance Functional orthodontic treatment Growing patients

Interventions

Mandibular advancement treatment using the Angelalign A6 clear aligner system with integrated mandibular advancement features. Treatment will involve staged mandibular advancement according to the man

Active Comparator Device,Active Comparator Device,Active Comparator Device,No Intervention No treatment

Angelalign A6 Mandibular Advancement System,Invisalign Mandibular Advancement System,Twin Block Functional Appliance,Untreated Control Group

Eligibility

Sex/Gender

All

Age

9 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1 Growing patients at cervical vertebral maturation stages 2 to 4. 2 Skeletal Class II malocclusion primarily due to mandibular retrusion. 3 Increased overjet requiring mandibular advancement treatment 4 Permanent or late mixed dentition stage 5 No previous orthodontic or functional appliance treatment 6 Good general health with no conditions affecting craniofacial growth 7 Willingness to comply with treatment and follow up requirements

Exclusion criteria

Exclusion criteria: 1 Craniofacial syndromes or cleft lip and palate 2 Systemic diseases or medications affecting craniofacial growth or bone metabolism 3 Previous orthodontic or functional appliance treatment 4 Severe facial asymmetry 5 Temporomandibular joint disorders or significant mandibular dysfunction 6 Impacted teeth or dental anomalies requiring complex multidisciplinary treatment 7 Poor oral hygiene or active periodontal disease 8 Incomplete clinical records or poor quality radiographs and digital models 9 Lack of compliance with treatment or follow up requirements 10 Patients requiring orthognathic surgery during the study period.

Design outcomes

Primary

Measure	Time frame
Change in Skeletal Sagittal Relationship Measured by SNB Angle and wits appraisal Following Mandibular Advancement Treatment in Growing Patients with Skeletal Class II Malocclusion Baseline prior to treatment or observation (T0) and completion of treatment or matched observation period (T1) SNB angle and wits appraisal measured on lateral cephalometric radiographs at T0 and T1. Treatment change calculated as the difference between pre treatment and post treatment values.	—

Measure

Time frame

Change in Skeletal Sagittal Relationship Measured by SNB Angle and wits appraisal Following Mandibular Advancement Treatment in Growing Patients with Skeletal Class II Malocclusion Baseline prior to treatment or observation (T0) and completion of treatment or matched observation period (T1) SNB angle and wits appraisal measured on lateral cephalometric radiographs at T0 and T1. Treatment change calculated as the difference between pre treatment and post treatment values.

—

Secondary

Measure	Time frame
Mandibular, dental, soft tissue, airway, TMJ, occlusal, pain, and patient satisfaction changes following treatment. Baseline prior to treatment or observation (T0) and completion of treatment or matched observation period (T1) Cephalometric analysis, digital models, CBCT assessment, PAR scoring, and patient questionnaires performed at baseline and post treatment or observation.	—

Countries

China

Contacts

Public ContactBUSHRA ALMAQRAMI

Ningbo yuniversity

bushraorth@gmail.com18064103497

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026