Trials / Completed
CompletedNCT05418413
The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion
Dentoskeletal Changes Resulting From Treatment of Skeletal Class II With an Esthetic Twin Block Appliance.
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Damascus University · Academic / Other
- Sex
- All
- Age
- 11 Years – 14 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CTB | 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. |
| DEVICE | ETB | 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 |
Timeline
- Start date
- 2021-12-28
- Primary completion
- 2022-09-30
- Completion
- 2023-02-28
- First posted
- 2022-06-14
- Last updated
- 2023-04-07
Locations
1 site across 1 country: Syria
Source: ClinicalTrials.gov record NCT05418413. Inclusion in this directory is not an endorsement.