- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00995436
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Derbyshire
-
Chesterfield, Derbyshire, United Kingdom, S445BL
- Chesterfield Royal Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
|
Extra oral anchorage
|
Active Comparator: Miniscrews
The intervention is the of miniscrews to supplement anchorage
|
Intraoral skeletal anchorage using mini screws
Other Names:
|
Active Comparator: Nance palatal arch
Anchorage supplemented by Nance palatal arch fixing molars together with an arch
|
Intraoral dental anchorage by using Nance palatal arch on molars
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Anchorage Loss Measured From 3-D Model Scanning
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient Perception of the Different Treatment Methods, Including Surgical Experience
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Investigators
- Study Chair: Jonathan Sandler, BDSMSc MOrth, Chesterfield North Derbyshire NHS Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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