A new appliance to correct skeletal class II malocclusion in growing patients

Evaluation of the efficiency of the modified orthodontic removable traction appliance versus twin block appliance in the treatment of skeletal class II malocclusion

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15028527

Enrollment

Registered

2023-10-25

Start date

2022-08-01

Completion date

Unknown

Last updated

2023-11-06

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

Conditions

Skeletal class II malocclusion Oral Health

Interventions

Randomization and sequence generation was done by one of the academic staff not involved in this study. With an allocation ratio of 1:1, a computer-generated list of random numbers was exported by Min

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Angle class II malocclusion because of mandibular retrognathia 2. Overjet between upper and lower incisors (OJ) >5 3. Angle between (sn) anterior cranial base and b point in mandible jaw (SNB) 402

Exclusion criteria

Exclusion criteria: 1. Temporomandibular joint (TMJ) disorders 2. Poor oral hygiene 3. Previous orthodontic treatment. 4. Patients with syndromes, clefts, or craniofacial abnormalities. 5. Reason for contraindication of functional treatment

Design outcomes

Primary

Measure	Time frame
1. Dentoskeletal mandible changes as measured by tomographic: changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 2. Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base: changes of the maxilla before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 3. Soft tissue changes before and after treatment will be assessed and compared with those of the control group (facial convexity angle, nasolabial angle, Z-Merrifield angle etc) using profile photography. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 4. The duration of functional treatment will be measured and compared between groups, after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months.	—

Measure

Time frame

1. Dentoskeletal mandible changes as measured by tomographic: changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 2. Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base: changes of the maxilla before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 3. Soft tissue changes before and after treatment will be assessed and compared with those of the control group (facial convexity angle, nasolabial angle, Z-Merrifield angle etc) using profile photography. Assessment will be done before treatment (T0) and after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months (T1). 4. The duration of functional treatment will be measured and compared between groups, after obtaining 0-1.5 mm overjet and the occlusion settled into a class I or superclass I molar relationship which will be approximately obtained after 8 months.

—

Secondary

Measure	Time frame
1. Level of discomfort assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 2. Level of acceptance assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 3. Level of acceptance assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 4. Number of broken appliances counted until the end of treatment	—

Measure

Time frame

1. Level of discomfort assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 2. Level of acceptance assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 3. Level of acceptance assessed using a questionnaire with a Visual Analog Scale (VAS) at baseline, 1 week, 3 months, end of treatment 4. Number of broken appliances counted until the end of treatment

—

Countries

Syria

Contacts

Public ContactBahaa ALdeen Joha

bahaa.joha@damascusuniversity.edu.sy+963 (0)934891818

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026