Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics (PJSPhD)
Primary Purpose
Malocclusion, Class II Buccal Segment Relationship
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Extraoral anchorage
Miniscrews
Nance
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion focused on measuring Extractions, Anchorage supplementation
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.
Sites / Locations
- Chesterfield Royal Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Extraoral anchorage
Miniscrews
Nance palatal arch
Arm Description
The intervention is the placement of Headgear, to be worn 100 hours per week
The intervention is the of miniscrews to supplement anchorage
Anchorage supplemented by Nance palatal arch fixing molars together with an arch
Outcomes
Primary Outcome Measures
Anchorage Loss Measured From 3-D Model Scanning
Secondary Outcome Measures
Patient Perception of the Different Treatment Methods, Including Surgical Experience
Full Information
NCT ID
NCT00995436
First Posted
October 14, 2009
Last Updated
August 3, 2016
Sponsor
Chesterfield and North Derbyshire Royal Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00995436
Brief Title
Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics
Acronym
PJSPhD
Official Title
Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chesterfield and North Derbyshire Royal Hospital
4. Oversight
Data Monitoring Committee
Yes
5. 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:
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Class II Buccal Segment Relationship
Keywords
Extractions, Anchorage supplementation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Extraoral anchorage
Arm Type
Active Comparator
Arm Description
The intervention is the placement of Headgear, to be worn 100 hours per week
Arm Title
Miniscrews
Arm Type
Active Comparator
Arm Description
The intervention is the of miniscrews to supplement anchorage
Arm Title
Nance palatal arch
Arm Type
Active Comparator
Arm Description
Anchorage supplemented by Nance palatal arch fixing molars together with an arch
Intervention Type
Device
Intervention Name(s)
Extraoral anchorage
Intervention Description
Extra oral anchorage
Intervention Type
Device
Intervention Name(s)
Miniscrews
Other Intervention Name(s)
miniscrew for anchorage reinforcement
Intervention Description
Intraoral skeletal anchorage using mini screws
Intervention Type
Device
Intervention Name(s)
Nance
Other Intervention Name(s)
Nance button
Intervention Description
Intraoral dental anchorage by using Nance palatal arch on molars
Primary Outcome Measure Information:
Title
Anchorage Loss Measured From 3-D Model Scanning
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Patient Perception of the Different Treatment Methods, Including Surgical Experience
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Sandler, BDSMSc MOrth
Organizational Affiliation
Chesterfield North Derbyshire NHS Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
S445BL
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24974994
Citation
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.
Results Reference
result
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Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics
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