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

Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics

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.

Study Overview

• Status: Completed
• Conditions: Malocclusion; Class II Buccal Segment Relationship
• Intervention / Treatment: Device: Extraoral anchorage; Device: Miniscrews; Device: Nance

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derbyshire
    • Chesterfield, Derbyshire, United Kingdom, S445BL
      • Chesterfield Royal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chesterfield and North Derbyshire Royal Hospital
• Investigators: Study Chair: Jonathan Sandler, BDSMSc MOrth, Chesterfield North Derbyshire NHS Trust

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: October 14, 2009
• First Submitted That Met QC Criteria: October 14, 2009
• First Posted (Estimate): October 15, 2009

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Extractions; Anchorage supplementation
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion
• Other Study ID Numbers: 07/Q2401/50; REC 07/Q2401/50 (Other Identifier: UK NHS Ethics); BOSF 2006 Grant 1 (Other Grant/Funding Number: British Orthodontics Foundation)