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

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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:
Information provided by (Responsible Party):
Jonathan Sandler, Chesterfield and North Derbyshire Royal Hospital

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia
U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995436


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

Publications of Results:
Responsible Party: Jonathan Sandler, Principal Investigator, Chesterfield and North Derbyshire Royal Hospital
ClinicalTrials.gov Identifier: NCT00995436     History of Changes
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    Key Record Dates
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