The effects of the Sydney Intrusion Spring (SIS) on the maxillary posterior dental segments with the application of an intrusive force.

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12610000154000
• Date of registration: 16/02/2010
• Prospective Registration: Yes
• Primary sponsor: Department of Orthodontics, University of Sydney
• Public title: The effects of the Sydney Intrusion Spring (SIS) on the maxillary posterior dental segments with the application of an intrusive force.
• Scientific title: The effects of the Sydney Intrusion Spring (SIS) on the amount and rate of intrusion with closure of the anterior open bite after the application of an intrusive force in 12-14 yr old children with maxillary transverse deficiency and skeletal anterior open bite malocclusion.
• Date of first enrolment: 01/04/2010
• Target sample size: 20
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12610000154000.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Riaan Foot

• Name: Dr Riaan Foot

Key inclusion & exclusion criteria

Inclusion criteria: Skeletal and dental open bite malocclusion
Makillary transverse deficiency.
Increased lower face height.
Adequate or excessive incisor display on smiling.
Convex facial profile
No non-nutritive sucking habits.
No severe posterior crowding.
Permanent dentition
No previous orthodontic treatment, trauma and no dental or congenital anomalies.
Good oral hygiene and no periodontal disease.
Exclusion criteria: Non-nutritive sucking habits.
Inadequate incisor display on smiling.
Straight to concave facial profile.
Mixed dentition.
Poor oral hygiene and periodontal disease

Age minimum: 12 Years
Age maximum: 14 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Skeletal open bite malocclusion;
Skeletal open bite malocclusion

Intervention(s)

Sydney Intrusion Spring, Miniscrew skeletal anchorage, Bonded Hyrax rapid maxillary expander will be placed at the start of the intervention. These appliances are all well established and commonly used in clinical orthodontic practice. The SIS will provide a continous intrusive force to the maxillary posterior teeth from the start to the end of the intervention. Measurements for amount and rate of intrusion will be taken at 6 weekly intervals. Anticipated duration of the intervention is 6-9 months, depending on the severity of the initial open bite.

Primary Outcome(s)

Millimetric measurement of the maxillary posterior teeth intrusion.[Millimetric measurements of the open bite will be taken at T=0 and then at 6 weekly intervals until a 2 mm over bite is achevied]

Secondary Outcome(s)

Reduction of the anterior over bite will be assesed making millimetric measurements across the upper and lower incisor teeth teeth using digital callipers.[Millimetric measurements of the open bite will be taken at T=0 and then at 6 weekly intervals until a 2 mm over bite is achevied]

Secondary ID(s)

None

Source(s) of Monetary Support

Department of Orthodontics, University of Sydney

Australian Society of Orthodontists

Secondary Sponsor(s)

Australian Society of Orthodontists

Ethics review

Status: Not approved
Approval date:
Contact:

Sydney South West Area Health Services (SSWAHS) [Royal Prince Alfred (RPA) zone] Ethics review committee