Class II Buccal Segment Relationship, Malocclusion
Conditions
Keywords
Extractions, Anchorage supplementation
Brief summary
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: 1. Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points 2. 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
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.
Interventions
DEVICEExtraoral anchorage
Extra oral anchorage
DEVICEMiniscrews
Intraoral skeletal anchorage using mini screws
DEVICENance
Intraoral dental anchorage by using Nance palatal arch on molars
Sponsors
Chesterfield and North Derbyshire Royal Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anchorage Loss Measured From 3-D Model Scanning | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Patient Perception of the Different Treatment Methods, Including Surgical Experience | 2 years |
Countries
United Kingdom
Participant flow
Recruitment details
This trial was conducted between August 2008 and February 2013 in two orthodontic departments in the United Kingdom.
Pre-assignment details
90 patients assesses as eligible. 12 chose not to take part
Participants by arm
| Arm | Count |
|---|---|
| Headgear Placement of extraoral traction to be worn 100 hours per week
Extraoral anchorage : Extra oral anchorage using headgear | 25 |
| Miniscrews Placement of micro-screw to supplement anchorage
Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws | 27 |
| 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 | 26 |
| Total | 78 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 5 | 0 |
Baseline characteristics
| Characteristic | Headgear | Miniscrews | Nance Palatal Arch | Total |
|---|---|---|---|---|
| Age, Continuous | 14.38 years STANDARD_DEVIATION 1.67 | 14.15 years STANDARD_DEVIATION 1.25 | 14.14 years STANDARD_DEVIATION 1.48 | 14.22 years STANDARD_DEVIATION 1.46 |
| Region of Enrollment United Kingdom | 25 participants | 27 participants | 26 participants | 78 participants |
| Sex: Female, Male Female | 10 Participants | 10 Participants | 19 Participants | 39 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 7 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 23 | 0 / 22 | 0 / 26 |
| serious Total, serious adverse events | 0 / 23 | 0 / 22 | 0 / 26 |
Outcome results
Primary
Anchorage Loss Measured From 3-D Model Scanning
Time frame: 2 years
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Miniscrews | Anchorage Loss Measured From 3-D Model Scanning | Maxillary right molar | 0.80 mm | Standard Deviation 1.6 |
| Miniscrews | Anchorage Loss Measured From 3-D Model Scanning | Maxillary left molar | 0.99 mm | Standard Deviation 1.15 |
| Nance Palatal Arch | Anchorage Loss Measured From 3-D Model Scanning | Maxillary right molar | 1.84 mm | Standard Deviation 1.32 |
| Nance Palatal Arch | Anchorage Loss Measured From 3-D Model Scanning | Maxillary left molar | 2.09 mm | Standard Deviation 1.32 |
| Headgear | Anchorage Loss Measured From 3-D Model Scanning | Maxillary right molar | 1.36 mm | Standard Deviation 1.83 |
| Headgear | Anchorage Loss Measured From 3-D Model Scanning | Maxillary left molar | 1.99 mm | Standard Deviation 2.09 |
95% CI: [-1.53, 0.36]
95% CI: [-1.89, -0.04]
95% CI: [-0.32, 1.55]
95% CI: [-1, 0.83]
p-value: 0.05ANCOVA
Comparison: Maxillary left molar.p-value: 0.08ANCOVA
Secondary
Patient Perception of the Different Treatment Methods, Including Surgical Experience
Time frame: 2 years