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

NCT ID: NCT00995436

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2013-10-31

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.

Conditions

Malocclusion; Class II Buccal Segment Relationship

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Extraoral anchorage

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

Group Type: ACTIVE_COMPARATOR

Extraoral anchorage

Intervention Type: DEVICE

Extra oral anchorage

Miniscrews

The intervention is the of miniscrews to supplement anchorage

Group Type: ACTIVE_COMPARATOR

Miniscrews

Intervention Type: DEVICE

Intraoral skeletal anchorage using mini screws

Nance palatal arch

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

Group Type: ACTIVE_COMPARATOR

Nance

Intervention Type: DEVICE

Intraoral dental anchorage by using Nance palatal arch on molars

Interventions

Extraoral anchorage

Extra oral anchorage

Intervention Type: DEVICE

Miniscrews

Intraoral skeletal anchorage using mini screws

Intervention Type: DEVICE

Nance

Intraoral dental anchorage by using Nance palatal arch on molars

Intervention Type: DEVICE

Other Intervention Names

miniscrew for anchorage reinforcement; Nance button

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chesterfield and North Derbyshire Royal Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Jonathan Sandler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Sandler, BDSMSc MOrth

Role: STUDY_CHAIR

Chesterfield North Derbyshire NHS Trust

Locations

Chesterfield Royal Hospital

Chesterfield, Derbyshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 24974994 (View on PubMed)

Other Identifiers

REC 07/Q2401/50

Identifier Type: OTHER

Identifier Source: secondary_id

BOSF 2006 Grant 1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

07/Q2401/50

Identifier Type: -

Identifier Source: org_study_id