Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics (PJSPhD)
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Purpose
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: 75 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 75 '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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malocclusion Patients Requiring Anchorage Reinforcement Class II Buccal Segment Relationship |
Device: Extraoral anchorage Device: Intraoral skeletal anchorage - Temporary anchorage device Device: Intraoral dental anchorage |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment |
| Official Title: | Efficiency and Effectiveness of Three Methods of Anchorage Reinforcement in Orthodontics |
- Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Patient perception of the different treatment methods, including surgical experience [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 75 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Headgear
Placement of extraoral traction to be worn 100 hours per week
|
Device: Extraoral anchorage
Extra oral anchorage using headgear
Other Name: Extraoral anchorage
|
|
Experimental: Miniscrews
Placement of micro-screw to supplement anchorage
|
Device: Intraoral skeletal anchorage - Temporary anchorage device
Intraoral skeletal anchorage using mini screws
Other Name: miniscrew for anchorage reinforcement
|
|
Experimental: Nance palatal arch
Anchorage supplemented by fixing molars together with an arch
|
Device: Intraoral dental anchorage
Intraoral dental anchorage by using Nance palatal arch on molars
Other Name: Nance button
|
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: 75 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 75 '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.
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United Kingdom | |
| Chesterfield Royal Hospital | |
| Chesterfield, Derbyshire, United Kingdom, S445BL | |
| Study Chair: | Jonathan Sandler, BDSMSc MOrth | Chesterfield North Derbyshire NHS Trust |
More Information
No publications provided
| Responsible Party: | Jonathan Sandler, Consultant Orthodontist, Chesterfield Royal Hospital |
| ClinicalTrials.gov Identifier: | NCT00995436 History of Changes |
| Other Study ID Numbers: | 07/Q2401/50, REC 07/Q2401/50, BOSF 2006 Gant 1 |
| Study First Received: | October 14, 2009 |
| Last Updated: | October 19, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by Chesterfield and North Derbyshire Royal Hospital:
|
Extractions Anchorage supplementation |
Additional relevant MeSH terms:
|
Malocclusion Tooth Diseases Stomatognathic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013