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

• ClinicalTrials.gov Identifier: NCT00995436
• Recruitment Status: Completed
• First Posted: October 15, 2009
• Results First Posted: August 5, 2016
• Last Update Posted: August 5, 2016
• Sponsor: Chesterfield and North Derbyshire Royal Hospital
• Information provided by (Responsible Party): Jonathan Sandler, Chesterfield and North Derbyshire Royal Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Malocclusion; Class II Buccal Segment Relationship	Device: Extraoral anchorage; Device: Miniscrews; Device: Nance	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 78 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics
• Study Start Date: July 2008
• Actual Primary Completion Date: October 2013
• Actual Study Completion Date: October 2013

Arms and Interventions

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 Name: 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 Name: Nance button

Outcome Measures

Primary Outcome Measures :

1. Anchorage Loss Measured From 3-D Model Scanning [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. Patient Perception of the Different Treatment Methods, Including Surgical Experience [ Time Frame: 2 years ]

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United Kingdom

Chesterfield Royal Hospital

Chesterfield, Derbyshire, United Kingdom, S445BL

Sponsors and Collaborators

Chesterfield and North Derbyshire Royal Hospital

Investigators

• Study Chair: Jonathan Sandler, BDSMSc MOrth; Chesterfield North Derbyshire NHS Trust

More Information

Publications of Results:

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.

• Responsible Party: Jonathan Sandler, Principal Investigator, Chesterfield and North Derbyshire Royal Hospital
• ClinicalTrials.gov Identifier: NCT00995436
• 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 )
• First Posted: October 15, 2009
• Results First Posted: August 5, 2016
• Last Update Posted: August 5, 2016
• Last Verified: August 2016

Keywords provided by Jonathan Sandler, Chesterfield and North Derbyshire Royal Hospital:

Extractions; Anchorage supplementation

Additional relevant MeSH terms:

Malocclusion; Tooth Diseases; Stomatognathic Diseases