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
  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:

  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 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

Resource links provided by NLM:


Further study details as provided by Chesterfield and North Derbyshire Royal Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00995436

Locations
United Kingdom
Chesterfield Royal Hospital
Chesterfield, Derbyshire, United Kingdom, S445BL
Sponsors and Collaborators
Chesterfield and North Derbyshire Royal Hospital
Royal Derbyshire Hospital
Investigators
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 April 15, 2014