NCT00995436

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. 1.Anchorage loss measured from lateral Cephalometric radiographs and 3-D model scanning, records will be taken at three points
  2. 2.Patient perception of the different treatment methods, including surgical experience

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 15, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

August 5, 2016

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

5.3 years

First QC Date

October 14, 2009

Results QC Date

February 3, 2014

Last Update Submit

August 3, 2016

Conditions

MalocclusionClass II Buccal Segment Relationship

Keywords

ExtractionsAnchorage supplementation

Outcome Measures

Primary Outcomes (1)

  • Anchorage Loss Measured From 3-D Model Scanning

    2 years

Secondary Outcomes (1)

  • Patient Perception of the Different Treatment Methods, Including Surgical Experience

    2 years

Study Arms (3)

Extraoral anchorage

ACTIVE COMPARATOR

The intervention is the placement of Headgear, to be worn 100 hours per week

Device: Extraoral anchorage

Miniscrews

ACTIVE COMPARATOR

The intervention is the of miniscrews to supplement anchorage

Device: Miniscrews

Nance palatal arch

ACTIVE COMPARATOR

Anchorage supplemented by Nance palatal arch fixing molars together with an arch

Device: Nance

Interventions

Extraoral anchorageDEVICE

Extra oral anchorage

Extraoral anchorage
MiniscrewsDEVICE

Intraoral skeletal anchorage using mini screws

Also known as: miniscrew for anchorage reinforcement
Miniscrews
NanceDEVICE

Intraoral dental anchorage by using Nance palatal arch on molars

Also known as: Nance button
Nance palatal arch

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Previous orthodontic treatment,
  • Unwillingness to accept any of the three methods of treatment, OR
  • Syndromes or clefts.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chesterfield Royal Hospital

Chesterfield, Derbyshire, S445BL, United Kingdom

Location

Related Publications (1)

  • Sandler J, Murray A, Thiruvenkatachari B, Gutierrez R, Speight P, O'Brien K. Effectiveness of 3 methods of anchorage reinforcement for maximum anchorage in adolescents: A 3-arm multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2014 Jul;146(1):10-20. doi: 10.1016/j.ajodo.2014.03.020.

    PMID: 24974994RESULT

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Results Point of Contact

Title
Jonathan Sandler
Organization
ChestyerfieldNDRH
JonSandler57@gmail.com
01246512106

Study Officials

  • Jonathan Sandler, BDSMSc MOrth

    Chesterfield North Derbyshire NHS Trust

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2009

First Posted

October 15, 2009

Study Start

July 1, 2008

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

August 5, 2016

Results First Posted

August 5, 2016

Record last verified: 2016-08

Locations

GB(1)