NCT02010346

Brief Summary

The aim of this longitudinal randomized investigation is to determine the long-term effects of early headgear treatment on craniofacial structures and dental arches, compared to treatment started later, during the most active growth period in Class II patients. The aim was further to find out the possible benefits and the burden of early treatment to the patients and parents of these common malocclusions, when compared to groups treated later, but with the same methods as much as possible. The hypothesis is that the timing of treatment has significant effects on orthodontic treatment total time, the general outcome of the treatment, and the compliance of the patient.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Status
unknown

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

January 1, 2005

Completed
8.9 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

June 13, 2018

Status Verified

June 1, 2018

Enrollment Period

14.9 years

First QC Date

December 9, 2013

Last Update Submit

June 11, 2018

Conditions

Malocclusion, Angle Class II

Keywords

Early orthodontic treatmentClass II treatmentOrthodontic treatment outcome

Outcome Measures

Primary Outcomes (1)

  • Normal occlusion, short treatment time

    Normal occlusion is measure as occusal contacts and overbite/overjet, but also on x-rays.

    10 years

Secondary Outcomes (1)

  • Patient compliance

    10 years

Other Outcomes (1)

  • Stability of occlusion in adulthood

    15 years

Study Arms (2)

Early headgear treatment

EXPERIMENTAL

Headgear treatment is initiated at the age of 7-8 years and continued as long as Class I occlusion is achieved

Procedure: Early headgear treatment

Later headgear treatment

NO INTERVENTION

Headgear treatment is initiated in the beginning of the growth spurt.

Interventions

Early headgear treatmentPROCEDURE

The treatment with headgear is done as early treatment, beginning at ages 7-8 (Arm 1), or later, durning the maximal growth (arm 2)

Also known as: Early orthodontic treatment, Orthodontic face bow, US patent: US 4212637 A, GAC 08-433-00 (NY,USA)
Early headgear treatment

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Angle Class II malocclusion
  • Overbite 5 mm or more

You may not qualify if:

  • Opening bite
  • Syndrome
  • Lateral malocclusion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Kasma K, Silvola AS, Vuollo V, Julku J. Effects of early and later timed cervical headgear treatment on the eruption timing and pattern of permanent upper canines and molars from 7 to 18 years of age: follow-up of a randomized controlled trial. Eur J Orthod. 2025 Jun 12;47(4):cjaf056. doi: 10.1093/ejo/cjaf056.

    PMID: 40576200DERIVED

  • Julku J, Pirila-Parkkinen K, Tolvanen M, Pirttiniemi P. Comparison of effects of cervical headgear treatment on skeletal facial changes when the treatment time is altered: a randomized controlled trial. Eur J Orthod. 2019 Nov 15;41(6):631-640. doi: 10.1093/ejo/cjz053.

    PMID: 31369675DERIVED

  • Julku J, Hannula M, Pirila-Parkkinen K, Tolvanen M, Pirttiniemi P. Dental arch effects after early and later timed cervical headgear treatment-a randomized controlled trial. Eur J Orthod. 2019 Nov 15;41(6):622-630. doi: 10.1093/ejo/cjy083.

    PMID: 30601990DERIVED

  • Julku J, Pirila-Parkkinen K, Pirttiniemi P. Airway and hard tissue dimensions in children treated with early and later timed cervical headgear-a randomized controlled trial. Eur J Orthod. 2018 May 25;40(3):285-295. doi: 10.1093/ejo/cjx088.

    PMID: 29228206DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class II

Interventions

Extraoral Traction Appliances

Condition Hierarchy (Ancestors)

MalocclusionTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances, RemovableOrthodontic AppliancesOrthodonticsDentistry

Study Officials

  • Pertti M. Pirttiniemi, Professor

    University of Oulu, Finland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2013

First Posted

December 12, 2013

Study Start

January 1, 2005

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

June 13, 2018

Record last verified: 2018-06