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

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Chesterfield and North Derbyshire Royal Hospital

Status

Completed

Conditions

Class II Buccal Segment Relationship

Malocclusion

Treatments

Device: Miniscrews

Device: Nance

Device: Extraoral anchorage

Study type

Interventional

Funder types

Other

Identifiers

NCT00995436

BOSF 2006 Grant 1 (Other Grant/Funding Number)

REC 07/Q2401/50 (Other Identifier)

07/Q2401/50

Details and patient eligibility

About

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.

Full 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

78 participants in 3 patient groups

Extraoral anchorage

Active Comparator group

Description:

The intervention is the placement of Headgear, to be worn 100 hours per week

Treatment:

Device: Extraoral anchorage

Miniscrews

Active Comparator group

Description:

The intervention is the of miniscrews to supplement anchorage

Treatment:

Device: Miniscrews

Nance palatal arch

Active Comparator group

Description:

Anchorage supplemented by Nance palatal arch fixing molars together with an arch

Treatment:

Device: Nance

Trial contacts and locations

1

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