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Trial registered on ANZCTR


Registration number
ACTRN12623000189628
Ethics application status
Approved
Date submitted
11/02/2023
Date registered
22/02/2023
Date last updated
24/03/2024
Date data sharing statement initially provided
22/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Dental and Skeletal Changes Following Bone- and Tooth-borne Maxillary Protraction with Miniscrews and Class III Elastics
Scientific title
Dental and Skeletal Changes Following Bone- and Tooth-borne Maxillary Protraction with Miniscrews and Class III Elastics in Patients aged 9 to 12 years
Secondary ID [1] 308981 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skeletal Class III malocclusion 328995 0
Condition category
Condition code
Oral and Gastrointestinal 325981 325981 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention involves placing four miniscrews (9mm or 7mm (PSM Medical Solutions, Tuttlingen, Germany)) – two on the anterior palate of the maxilla and two on the buccal surfaces of the mandible (one on each side between the permanent first and second premolar, or between the permanent canine and first premolar). They will be placed under local anaesthesia by orthodontic postgraduate students or orthodontists. Miniscrew insertion will be followed by an intraoral scan (TRIOS; 3Shape, Copenhagen, Denmark). The intraoral scan will be sent to the dental technician, who will design the maxillary and mandibular frameworks that will be fitted over the miniscrews, under instruction of the chief investigator/supervisor. The duration of the procedure will take 45 minutes.

After 2 weeks, the frameworks will be cemented. Two weeks is the usual turnover time for dental laboratories. The maxillary framework will join the metal bands around the permanent first premolar and molar, bilaterally. There will be a traction button on the buccal surface of permanent first molar's metal band, to allow placement of Class III elastics to the lower framework, exerting a force to move the maxilla forward. A Hyrax screw (Forastadent, Pforzheim, Germany – 10mm) will be incorporated if needed, in patients with transverse maxillary deficiency. Similarly, the mandibular framework will join the metal bands around the permanent canines or first premolars (in the case where the canine has not erupted yet) and first molars. A traction button will be located on the anterior buccal surfaces of the framework, for placement of Class III elastics. The final metal framework designs will be printed by selective laser melting process using the material Remanium Star (Dentaurum, Ispringen, Germany), electro-polished, and the bonding surfaces will be sandblasted.

The dental surfaces will be acid etched with 37% phosphoric acid gel for 30 seconds. After rinsing and air drying, Rely X Unicem (3M ESPE, St Paul, Minn) will be used to cement the appliances and will be light-cured for 30 seconds. Finally, fixation screws will be placed, to secure the frameworks over the miniscrews. The patient will then be instructed to use 6 oz 3/16-in Class III elastics full-time (i.e. at all times besides meals and brushing teeth), to be replaced at least three times a day. The cementation of the framework will take 45 minutes.

Patients will be monitored 3-4 weeks after the appliances have been placed, followed by every 2 months subsequently. The total duration of the study for each participant will be a maximum of 12 months. Once the Class III malocclusion has been corrected, the miniscrews and elastics will be removed/discontinued.

Dental measurements will be measured on the intra-oral scans, to assess the dental effects. Radiographically, cephalometric analysis of pre- and post-treatment lateral cephalograms will be conducted to assess the skeletal effects. Both pre- and post-treatment lateral cephalograms will also be superimposed to provide a visual aid of the skeletal and dental changes that occur over time. Before and after comparisons will be made with subsequent data analysis processed using SPSS statistical software with the aid of a statistician.
Intervention code [1] 325423 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333837 0
Linear (millimetric) and angular measurement of the correction of class III malocclusion assessed by lateral cephalograms
Timepoint [1] 333837 0
Baseline (pre-intervention), 12 months after intervention commencement
Primary outcome [2] 333904 0
Millimetric measurement of the correction of class III malocclusion assessed by intra-oral scans of dentition
Timepoint [2] 333904 0
Baseline (pre-intervention), 12 months after intervention commencement
Secondary outcome [1] 418444 0
Nil
Timepoint [1] 418444 0
Nil

Eligibility
Key inclusion criteria
-Patients with skeletal Class III pattern with horizontal maxillary deficiency
-Patients in their pre-pubertal growth phase
-Patients with permanent mandibular premolars/permanent mandibular canine and first premolar erupted
Minimum age
9 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-No congenital anomalies or craniofacial syndrome
-No medical history that affects growth

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
31/03/2023
Actual
24/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
15
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24032 0
The Royal Dental Hospital of Melbourne - Carlton
Recruitment postcode(s) [1] 39525 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 313195 0
Charities/Societies/Foundations
Name [1] 313195 0
The Australian Society of Orthodontists' Foundation for Research and Education
Country [1] 313195 0
Australia
Primary sponsor type
Individual
Name
Professor Marie Cornelis
Address
University of Melbourne School of Dentistry, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country
Australia
Secondary sponsor category [1] 314908 0
None
Name [1] 314908 0
Address [1] 314908 0
Country [1] 314908 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312427 0
Office of Research Ethics and Integrity, University of Melbourne
Ethics committee address [1] 312427 0
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [1] 312427 0
Australia
Date submitted for ethics approval [1] 312427 0
12/12/2022
Approval date [1] 312427 0
15/03/2023
Ethics approval number [1] 312427 0

Summary
Brief summary
The intervention involves placing four miniscrews (two on the maxilla and two on the mandible) which the frameworks will be fitted over, Class III elastics attached to the frameworks will be worn full-time until the skeletal Class III malocclusion is corrected. The aim of this trial is to evaluate the dental and skeletal changes of skeletal Class III patients treated with Bone- and Tooth-borne Maxillary protraction with Miniscrews and Class III Elastics.

The null hypothesis is that there will be no dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics, when comparing the pre- and post-treatment situation. The alternative hypothesis is there will be a dental and skeletal effects of maxillary protraction using miniscrews and Class III elastics.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124626 0
Prof Marie Cornelis
Address 124626 0
University of Melbourne School of Dentistry, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country 124626 0
Australia
Phone 124626 0
+61 3 9341 1498
Fax 124626 0
Email 124626 0
[email protected]
Contact person for public queries
Name 124627 0
Denice Loo
Address 124627 0
University of Melbourne School of Dentistry, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country 124627 0
Australia
Phone 124627 0
+613 9035 8402
Fax 124627 0
Email 124627 0
[email protected]
Contact person for scientific queries
Name 124628 0
Marie Cornelis
Address 124628 0
University of Melbourne School of Dentistry, Orthodontic Department 720 Swanston Street Carlton VIC 3053
Country 124628 0
Australia
Phone 124628 0
+61 3 9341 1498
Fax 124628 0
Email 124628 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified individual line-by-line data
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
Researchers who provide a sound proposal
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Contact principal investigator via email [email protected]


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.