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| ID | Type | Description | Link |
|---|---|---|---|
| REC 07/Q2401/50 | Other Identifier | UK NHS Ethics | |
| BOSF 2006 Grant 1 | Other Grant/Funding Number | British Orthodontics Foundation |
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Research problem:
Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective. Microscrews despite their popularity however have no scientific evidence to support their use.
Aim:
To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance palatal arch 3) orthodontic micro-screws.
Hypothesis:
There is no difference in the amount of anchorage loss between the three methods of anchorage reinforcement.
Design:
Randomized clinical trial.
Setting: District General Hospital orthodontic department
Participants: 78 patients requiring "absolute anchorage".
Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for anchorage.
Method of investigation:
The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned to one of three groups of anchorage reinforcement
Outcome measures:
Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive statistics and uni-variate tests will initially be done to explore the data. Final data analysis will involve the relevant multi-variate statistical modeling.
Dissemination: Conference proceedings, journal papers and the Cochrane oral health group.
Research problem:
Anchorage reinforcement is effective with headgear provided patient compliance is optimal. Nance palatal arch have also been shown to be effective. Microscrews despite their popularity however have no scientific evidence to support their use.
Aim:
To compare the effectiveness of 3 methods of anchorage reinforcement 1) headgear 2) Nance palatal arch 3) orthodontic micro-screws.
Hypothesis:
There is no difference in the amount of anchorage loss between the three methods of anchorage reinforcement.
Design:
Randomized clinical trial.
Setting: District General Hospital orthodontic department
Participants: 78 patients requiring "absolute anchorage".
Interventions: The subjects will be randomized into 3 groups. In group 1 headgear will be requested 12-14 hours per day. In group 2 a nance palatal arch will be placed for use as intra oral anchorage reinforcement. In group 3, orthodontic micro-screws will be used for anchorage.
Method of investigation:
The study will be of 78 'absolute anchorage' patients older than 12 years randomly assigned to one of three groups of anchorage reinforcement
Data analysis: The data will be analysed on an intention to treat basis. Basic descriptive statistics and uni-variate tests will initially be done to explore the data. Final data analysis will involve the relevant multi-variate statistical modeling.
I took professional statistical advice from a senior statistician at the University of Manchester. Analysis of covariance was used and Headgear (as our default treatment) was used as the reference category. Results with Nance and TADs are relative to the reference category of headgear.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extraoral anchorage | Active Comparator | The intervention is the placement of Headgear, to be worn 100 hours per week |
|
| Miniscrews | Active Comparator | The intervention is the of miniscrews to supplement anchorage |
|
| Nance palatal arch | Active Comparator | Anchorage supplemented by Nance palatal arch fixing molars together with an arch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extraoral anchorage | Device | Extra oral anchorage |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Anchorage Loss Measured From 3-D Model Scanning | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Perception of the Different Treatment Methods, Including Surgical Experience | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Sandler, BDSMSc MOrth | Chesterfield North Derbyshire NHS Trust | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chesterfield Royal Hospital | Chesterfield | Derbyshire | S445BL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24974994 | Result | Sandler J, Murray A, Thiruvenkatachari B, Gutierrez R, Speight P, O'Brien K. Effectiveness of 3 methods of anchorage reinforcement for maximum anchorage in adolescents: A 3-arm multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2014 Jul;146(1):10-20. doi: 10.1016/j.ajodo.2014.03.020. |
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90 patients assesses as eligible. 12 chose not to take part
This trial was conducted between August 2008 and February 2013 in two orthodontic departments in the United Kingdom.
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| ID | Title | Description |
|---|---|---|
| FG000 | Headgear | Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage : Extra oral anchorage using headgear |
| FG001 | Miniscrews | Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws |
| FG002 | Nance Palatal Arch | Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Headgear | Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage : Extra oral anchorage using headgear |
| BG001 | Miniscrews | Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anchorage Loss Measured From 3-D Model Scanning | Posted | Mean | Standard Deviation | mm | 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Headgear | Device Placement of extraoral traction to be worn 100 hours per week Extraoral anchorage: Extra oral anchorage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Sandler | ChestyerfieldNDRH | 01246512106 | JonSandler57@gmail.com |
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| ID | Term |
|---|---|
| D008310 | Malocclusion |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| Miniscrews |
| Device |
Intraoral skeletal anchorage using mini screws |
|
|
| Nance | Device | Intraoral dental anchorage by using Nance palatal arch on molars |
|
|
| BG002 | Nance Palatal Arch | Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Patient Perception of the Different Treatment Methods, Including Surgical Experience | Not Posted | 2 years |
| 0 |
| 23 |
| 0 |
| 23 |
| EG001 | Miniscrews | Device Placement of micro-screw to supplement anchorage Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws | 0 | 22 | 0 | 22 |
| EG002 | Nance Palatal Arch | Anchorage supplemented by fixing molars together with an arch Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars | 0 | 26 | 0 | 26 |
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