Early Crossbite Correction - a Randomized Study

NCT03353766 | Unknown

• 1 other identifier: EETTMK:124/2008
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this longitudinal randomized investigation is to determine the long-term effects of early lateral crossbite correction with Quad-Helix appliance, during the deciduous dentition, on craniofacial structures and dental arches, compared to treatment started later, after the first permanent molars have erupted. 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. The Age cohort of five-year-old of children living in the community areas of Oulunsalo are screened at the age of 5 years for malocclusions. Of these children 80 children who meet the criteria are chosen for the study after the written consent. The children are randomized into two groups. In the first group the treatment with Quad-Helix appliance is started at the age of 5 to 6 years, before the eruption of the permanent molars. The device is cemented to the second deciduous molars. The treatment is continued and continued until normal lateral occlusion is achieved and the device is kept stable for one year after this. In the second group headgear treatment is started after the first permanent maxillary molars have erupted. The device is cemented to the first permanent molars. The treatment is continued until normal lateral occlusion is achieved and the device is kept stable for one year after this. In both groups dental casts, cephalograms, and standardized 3D facial photographs are taken before treatment (T0), after the first treatment phase (T1), after the second treatment phase (T2) and after the growth (T3). Facial 3D scanning is performed for all the subjects after the treatment to find out the effect of different treatment methods on facial characteristics. The dental casts are scanned to make 3D models of the cast to be used in detailed analysis. A wide multi-level questionnaire is performed before, during and after the study to the parents and the children to find out the comprehensive effects of orthodontic treatment on the well-being of the child. The questionnaire includes the Rutter's child behavioural pattern (Rutter et al., 2001). In both studies, all the guidelines of RCT are applied. Blinding of the clinicians is gained, as the orthodontists or dentists treating the children are not aware of the rationale of the study. Blinding is applied on all measurement of the documents.

Conditions

Malocclusion; Crossbite

Keywords

Early Orthodontic treatment; Orthodontic treatment outcome; Crossbite treatment

Outcome Measures

Primary Outcomes (1)

• Normal occlusion, no lateral crossbite, normal measured Overjet and Overbite

  Normal occlusion is measured as: * harmonous occlusal contacts, no lateral crossbite * Overbite 1 mm to 4 mm * Overjet 1mm to 4 mm

  13 years

Secondary Outcomes (2)

• Patient compliance, questionnaire

  6 years

• Stability of occlusion in long-term follow-ups.

  13 years

Other Outcomes (1)

• Measured degree of facial asymmetries

  13 years

Study Arms (2)

Early crossbite correction

EXPERIMENTAL

Early crossbite correction with Q-H Device

Device: Early crossbite correction with Q-H Device

Crossbite correction in mixed dentition

NO INTERVENTION

Later crossbite correction, during mixed dentition

Interventions

Early crossbite correction with Q-H Device DEVICE

Crossbite treatment in deciduous dentition with Quad-Helix appliance

Also known as: Expanding device, Maxillary expansion

Early crossbite correction

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Crossbite of at least two deciduous lateral teeth
• Full deciduous dentition
• Age 5 to 6 years

You may not qualify if:

• Anterior crossbite
• Missing permanent teeth,
• Craniofacial syndrome, Cleft lip/palate

Sponsors & Collaborators

• University of Oulu: lead
• Oulu University Hospital: collaborator

Study Sites (1)

University of Oulu

Oulu, 90450, Finland

RECRUITING

Related Publications (8)

• Krusinskiene V, Kiuttu P, Julku J, Silvola AS, Kantomaa T, Pirttiniemi P. A randomized controlled study of early headgear treatment on occlusal stability--a 13 year follow-up. Eur J Orthod. 2008 Aug;30(4):418-24. doi: 10.1093/ejo/cjn021. Epub 2008 Jul 16.

  PMID: 18632838 BACKGROUND

• Lippold C, Stamm T, Meyer U, Vegh A, Moiseenko T, Danesh G. Early treatment of posterior crossbite--a randomised clinical trial. Trials. 2013 Jan 22;14:20. doi: 10.1186/1745-6215-14-20.

  PMID: 23339736 BACKGROUND

• Mantysaari R, Kantomaa T, Pirttiniemi P, Pykalainen A. The effects of early headgear treatment on dental arches and craniofacial morphology: a report of a 2 year randomized study. Eur J Orthod. 2004 Feb;26(1):59-64. doi: 10.1093/ejo/26.1.59.

  PMID: 14994883 BACKGROUND

• Petren S, Bjerklin K, Bondemark L. Stability of unilateral posterior crossbite correction in the mixed dentition: a randomized clinical trial with a 3-year follow-up. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e73-81. doi: 10.1016/j.ajodo.2010.06.018.

  PMID: 21195260 BACKGROUND

• Pirttiniemi P, Kantomaa T, Mantysaari R, Pykalainen A, Krusinskiene V, Laitala T, Karikko J. The effects of early headgear treatment on dental arches and craniofacial morphology: an 8 year report of a randomized study. Eur J Orthod. 2005 Oct;27(5):429-36. doi: 10.1093/ejo/cji025. Epub 2005 Jun 16.

  PMID: 15961567 BACKGROUND

• Silvola AS, Arvonen P, Julku J, Lahdesmaki R, Kantomaa T, Pirttiniemi P. Early headgear effects on the eruption pattern of the maxillary canines. Angle Orthod. 2009 May;79(3):540-5. doi: 10.2319/021108-83.1.

  PMID: 19413375 BACKGROUND

• Tsanidis N, Antonarakis GS, Kiliaridis S. Functional changes after early treatment of unilateral posterior cross-bite associated with mandibular shift: a systematic review. J Oral Rehabil. 2016 Jan;43(1):59-68. doi: 10.1111/joor.12335. Epub 2015 Aug 8.

  PMID: 26257271 BACKGROUND

• Godoy F, Godoy-Bezerra J, Rosenblatt A. Treatment of posterior crossbite comparing 2 appliances: a community-based trial. Am J Orthod Dentofacial Orthop. 2011 Jan;139(1):e45-52. doi: 10.1016/j.ajodo.2010.06.017.

  PMID: 21195256 RESULT

MeSH Terms

Conditions

Malocclusion

Interventions

Palatal Expansion Technique

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontics, Corrective; Orthodontics; Dentistry

Study Officials

• Anna-Sofia Silvola, Dr.

  University of Oulu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pertti M. Pirttiniemi, Professor

CONTACT

+358405224199; pertti.pirttiniemi@oulu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2016
• First Posted: November 27, 2017
• Study Start: April 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2025
• Last Updated: November 27, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)