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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Royal Derbyshire Hospital
Information provided by:
Chesterfield and North Derbyshire Royal Hospital
ClinicalTrials.gov Identifier:
NCT00995436
First received: October 14, 2009
Last updated: October 19, 2009
Last verified: October 2009

October 14, 2009
October 19, 2009
July 2008
July 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00995436 on ClinicalTrials.gov Archive Site
Patient perception of the different treatment methods, including surgical experience [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chesterfield Micro-implant Study Involving Three Types of Anchorage Methods in Orthodontics
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: 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:

  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.

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Malocclusion
  • Patients Requiring Anchorage Reinforcement
  • Class II Buccal Segment Relationship
  • Device: Extraoral anchorage
    Extra oral anchorage using headgear
    Other Name: Extraoral anchorage
  • Device: Intraoral skeletal anchorage - Temporary anchorage device
    Intraoral skeletal anchorage using mini screws
    Other Name: miniscrew for anchorage reinforcement
  • Device: Intraoral dental anchorage
    Intraoral dental anchorage by using Nance palatal arch on molars
    Other Name: Nance button
  • Experimental: Headgear
    Placement of extraoral traction to be worn 100 hours per week
    Intervention: Device: Extraoral anchorage
  • Experimental: Miniscrews
    Placement of micro-screw to supplement anchorage
    Intervention: Device: Intraoral skeletal anchorage - Temporary anchorage device
  • Experimental: Nance palatal arch
    Anchorage supplemented by fixing molars together with an arch
    Intervention: Device: Intraoral dental anchorage
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
75
July 2012
July 2011   (final data collection date for primary outcome measure)

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.
Both
12 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00995436
07/Q2401/50, REC 07/Q2401/50, BOSF 2006 Gant 1
Yes
Jonathan Sandler, Consultant Orthodontist, Chesterfield Royal Hospital
Chesterfield and North Derbyshire Royal Hospital
Royal Derbyshire Hospital
Study Chair: Jonathan Sandler, BDSMSc MOrth Chesterfield North Derbyshire NHS Trust
Chesterfield and North Derbyshire Royal Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP