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Completed

NCT Number: NCT05418413

The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion

This experimental study will evaluate the effect of an esthetic Twin-block appliance on the correction of class II malocclusion compared with the traditional Twin-block appliance.

The study sample will consist of 50 patients with class II malocclusion. The sample will be allocated randomly into two groups: the control group and the experimental group.

The traditional Twin-block appliance will be applied for the control group patients, while the esthetic Twin-block appliance will be applied for the experimental group patients. The dentoskeletal, soft tissue changes and esthetic and functional efficacy occurring after functional treatment will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. Changes for each group will be evaluated individually, and the two groups will be compared.

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Key information

Conditions

Class II Malocclusion Malocclusion Malocclusion, Angle Class II Overbite Stomatognathic Diseases Tooth Diseases

Age range

11 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Damascus

Damascus, Syria

About this study

Class II malocclusion is one of the most frequent orthodontic problems, and most class II malocclusion cases are the result of mandibular deficiency. Twin block (TB) is one of the most popular functional appliances to treat this condition. Despite excellent treatment results with TB, its acceptance and compliance may be hampered by its wiry structure and appearance. Furthermore, it has a side effect of causing the proclination of lower incisors, which reduces skeletal change. Various modifications were proposed to reduce lower incisors proclination but had no significant effect. Patient cooperation is one of the most important factors for successful functional appliance treatment, and it depends upon comfort and esthetic acceptability, which ensures good patient compliance. so, in order to enhance the esthetic appearance and overcome the disadvantages of a conventional Twin-Block (CTB), a novel esthetic Twin-Block (ETB) was fabricated from a specific material using a pressure molding device and acrylic bite blocks. There is only one study that evaluated this appliance which is a pilot study that compared the treatment effects of the (ETB) and (CTB) in the treatment of Class II malocclusions. However, this study has a lot of limitations, making it difficult to evaluate this appliance's efficiency accurately. The aim of this study is to study the dento-skeletal, soft tissue changes, and esthetic and functional efficacy that result from treatment by this appliance (ETB) and to compare them to the changes in the matched group will be treated with (CTB), by studying the cephalometric radiographs, profile photographs, and a questionnaire.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Angle class II malocclusion because of mandibular retrognathia
  • O.J > 5 , SNB < 78
  • Patient during growth spurt
  • Normal or horizontal growth pattern Björk > 402

Exclusion criteria

  • TMJ disorders
  • Poor oral hygiene
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Reason of contraindication of functional treatment

Treatment and study plan

CTB

Device

conventional Twin-block (CTB) will be comprised of maxillary and mandibular removable appliances having the labial bows, adam's clasps, and with no incisal capping.

ETB

Device

will be comprised of maxillary and mandibular removable 1.5-mm biocryl sheet will be adapted separately on maxillary and mandibular casts with help of vacuum machine, and Acrylic bite blocks with the inclined plane will be fabricated on biocryl sheets sim

Primary outcomes

  1. Dentoskeletal mandible changes as measured by tomographic

    Time frame: 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).

    changes of the mandible before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs

  2. Lower incisor angle changes

    Time frame: Changes will be evaluated before treatment 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)

    Lower incisor angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  3. ANB angle changes

    Time frame: Changes will be evaluated before treatment 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)

    ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

Secondary outcomes

  1. Dentoskeletal maxilla changes as measured by tomographic superimposition of the cranial base

    Time frame: 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)

    changes of the maxilla before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  2. SNA angle changes

    Time frame: 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)

    SNA angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  3. SNB angle changes

    Time frame: 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).

    SNB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  4. Soft tissue changes

    Time frame: 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)

    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.

  5. The duration of functional treatment

    Time frame: 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

    The duration of the functional treatment will be measured and compared between groups.

  6. Levels of pain

    Time frame: A questionnaire will be given to the patients five times during treatment; after 1 week, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.

    The level of pain will be assessed and compared with those of the control group using a questionnaire with a Visual Analog Scale (VAS). The VAS is a 10-cm horizontal line with two focal points at its beginning and end (0: there is no pain - 10: the worst pain).

  7. Levels of discomfort

    Time frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.

    The level of discomfort will be assessed and compared with those of the control group using a questionnaire with a Visual Analog Scale (VAS). The VAS is a 10-cm horizontal line with two focal points at its beginning and end (0: there is no discomfort - 10: the worst discomfort).

  8. Levels of acceptance

    Time frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 6 weeks, after 3 months and at the end of the application of the appliance.

    The level of acceptance will be assessed and compared with those of the control group using a questionnaire with a Visual Analog Scale (VAS). The VAS is a 10-cm horizontal line with two focal points at its beginning and end (0: no acceptance - 10: the best acceptance).

  9. Number of broken appliances

    Time frame: During the treatment time which will take approximately 8 months.

    The number of broken will be counted and compared with those of the control group .

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Dentoskeletal Changes Resulting From Treatment of Skeletal Class II With an Esthetic Twin Block Appliance.

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 14, 2022
Registry last updated
Apr 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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