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

C

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.

Enrollment

78 patients

Sex

All

Ages

12 to 17 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

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

0

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Data sourced from clinicaltrials.gov

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