Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics

Study Overview
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Brief Summary
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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: Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points Patient perception of the different treatment methods, including surgical experience 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.

Detailed Description
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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 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.

Official Title
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Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics

Conditions
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Malocclusion, Class II Buccal Segment Relationship

Intervention / Treatment
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* Device: Extraoral anchorage
* Device: Miniscrews
* Device: Nance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seventy-five children maximum anchorage cases, aged aged 12-17 referred from the General Dental Service to Chesterfield Royal Hospital will be selected to take part in this study. Informed consent will be obtained. Exclusion Criteria: Previous orthodontic treatment, Unwillingness to accept any of the three methods of treatment, OR Syndromes or clefts.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extraoral anchorage<br>The intervention is the placement of Headgear, to be worn 100 hours per week | Device: Extraoral anchorage<br>* Extra oral anchorage<br>|
| Active Comparator: Miniscrews<br>The intervention is the of miniscrews to supplement anchorage | Device: Miniscrews<br>* Intraoral skeletal anchorage using mini screws<br>* Other names: miniscrew for anchorage reinforcement;|
| Active Comparator: Nance palatal arch<br>Anchorage supplemented by Nance palatal arch fixing molars together with an arch | Device: Nance<br>* Intraoral dental anchorage by using Nance palatal arch on molars<br>* Other names: Nance button;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anchorage Loss Measured From 3-D Model Scanning |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Perception of the Different Treatment Methods, Including Surgical Experience |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Extractions, Anchorage supplementation