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| Name | Class |
|---|---|
| National Health Service, United Kingdom | OTHER_GOV |
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The aim of this study is to assess skeletal (bone) and dental (teeth) changes occurring following wear of a twin block functional appliance (removable brace which postures the lower jaw forward to improve a discrepancy between the upper and lower jaw) for differing time periods.
Functional appliances are ordinarily worn full time in adolescence between 11 and 14 years with a discrepancy between their upper and lower jaws. The reason it is worn between these ages is to avail of the pre pubertal growth spurt, evidence for full time wear is merely empirical.If this appliance only had to be worn part time it would have a significant change in orthodontics in terms of patient acceptance and compliance.The investigators plan on recruiting 84 patients to the study and these subjects will be referred from hospital colleagues. The investigators will randomly allocate the subjects into 2 groups, Group 1 will wear the appliance Full Time(24hours), group 2 will wear the appliance part time(12hours).
The study will be conducted in the Dental Institute at the Royal London Hospital, this hospital setting will be the sole site.
The study will last for 15 months from the time the last patient is recruited. Participants will undergo an initial records appointment where a radiograph and clinical measurements will be taken followed by 12 months of functional appliance treatment where the patient will be reviewed at 6-8weekly intervals and clinical measurements taken.A final radiograph will be taken at 15months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part time (12hour) wear | Active Comparator | the' Modified Clark Twin Block' will be worn part time |
|
| Full time (24hour) wear | Active Comparator | the ' Modified Clark Twin Block' will be worn full time |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified Clark Twin Block | Device | The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones |
| Measure | Description | Time Frame |
|---|---|---|
| remaining overjet measured with an orthodontic ruler | the initial overjet will compared to the final overjet following 12 months of appliance treatment, and 3 months of relapse. overjet will be measured with an orthodontic ruler at every review appointment | outcome measure will be assessed after 12 months appliance wear and after a 3 month relapse period |
| Cephalometric Changes | Both linear and angular cephalometric changes will be assessed over this timeframe. | Outcome will be assessed after 12m of appliance wear and after 3 months of settling. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of subjective and objective measures of appliance wear | Subjective (patient completed time charts) and objective (theramon micro-sensor) measures of wear will be assessed over 12months of appliance wear. | 12 months of appliance wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Counihan, BDS | Queen Mary University of London | Principal Investigator |
| Jeet Parekh, BDS | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dental Insitiute Royal London Hospital | London | London | E1 1BB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30712687 | Derived | Parekh J, Counihan K, Fleming PS, Pandis N, Sharma PK. Effectiveness of part-time vs full-time wear protocols of Twin-block appliance on dental and skeletal changes: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2019 Feb;155(2):165-172. doi: 10.1016/j.ajodo.2018.07.016. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 13, 2020 | |
| Reset | Jan 23, 2020 | |
| Release | Jun 6, 2025 | |
| Reset | Jun 25, 2025 | |
| Release | Aug 1, 2025 | |
| Reset | Aug 19, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 13, 2020 | Jan 23, 2020 | |||
| Jun 6, 2025 |
| ID | Term |
|---|---|
| D008312 | Malocclusion, Angle Class II |
| ID | Term |
|---|---|
| D008310 | Malocclusion |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Jun 25, 2025 |
| Aug 1, 2025 | Aug 19, 2025 |