Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000321640
Ethics application status
Approved
Date submitted
5/02/2014
Date registered
26/03/2014
Date last updated
26/03/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of light and heavy forces in alternating directions (jiggling) versus light and heavy unidirectional forces on the distribution and volume of orthodontically induced inflammatory root resorption lesions in patients undergoing orthodontic treatment.
Scientific title
The effect of alternating light and heavy forces (jiggling) versus light and heavy unidirectional forces on root resorption crater volumes and distribution as measured by Micro CT in patients requiring orthodontic treatment for malaligned teeth or jaws
Secondary ID [1] 284030 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Orthodontically Induced Inflammatory Root Resorption 291079 0
Malaligned teeth/jaws 291114 0
Condition category
Condition code
Oral and Gastrointestinal 291424 291424 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 under study involves Light (25g) and Heavy (225g) forces applied to a randomly allocated right or left upper first premolar with the direction of force alternating every 4 weeks over a 12 week period. Forces will be applied in one direction for 4weeks, the alternate direction for another 4 weeks and in the original direction for 4 weeks. These forces will be applied to the teeth via orthodontic brackets bonded to the maxillary first molars and first premolars, and 0.0017 x 0.025” Titanium Molybdenum Alloy (TMA) archwires in heavy force groups and 0.016” TMA wire springs in light force groups to produce 225 and 25 grams of tipping forces respectively on the upper first premolars throughout the 4 week period.

Following enrolment, patients will be randomly allocated to one of four groups with the following parameters:

Group LHJ: Light and Heavy Jiggling Movement Group (Transverse): A randomly allocated left/right first premolar will undergo light jiggling movements, while the contralateral premolar will undergo heavy jiggling movements in the transverse plane.

Group PCLJ: Positive Control light (Unidirectional) and Light Jiggling Movement Group (Transverse): A randomly allocated left/right first premolar will undergo light unidirectional movements while the contralateral premolar will undergo light jiggling movements in the transverse plane.

Group PCHJ: Positive Control Heavy (Unidirectional) and Heavy Jiggling Movement Group (Transverse): The randomly allocated left/right first premolar will have heavy unidirectional movements while the contralateral premolar will have heavy jiggling movements applied.

Group HBIJ: Heavy Transverse and Vertical Jiggling Movement Group: The randomly allocated left/right first premolar will have heavy transverse jiggling movements while the contralateral premolar will have heavy vertical movements applied.
Intervention code [1] 288722 0
Treatment: Other
Comparator / control treatment
The comparator treatment involves unidirectional light (25g) or heavy (225) orthodontic force applied in the horizontal plane for 12 weeks, with review and reactivation of forces as required at 4 weekly intervals.

Patients allocated to the PCLJ and PCJH groups will act as their own control when analysing the effect of light and heavy jiggling movements respectively.

Patients allocated to LHJ and HBIJ groups will act as their own control when comparing the effects of light and heavy jiggling movements, and heavy transverse and heavy vertical movements respectively.
Control group
Active

Outcomes
Primary outcome [1] 291412 0
Distribution of first premolar root resorption craters as determined by Micro Computed Tomography
Timepoint [1] 291412 0
At the end of 12 weeks, after the teeth are extracted
Secondary outcome [1] 306716 0
Volume of first premolar root resorption craters as determined by Micro Computed Tomography
Timepoint [1] 306716 0
At the end of 12 weeks, after the teeth are extracted

Eligibility
Key inclusion criteria
1. Patient who requires removal of bilateral first premolar teeth as part of orthodontic treatment.
2. No previous reported or observed dental treatment to the teeth to be extracted
3. No previous reported or observed trauma to the teeth to be extracted
4. No previous reported orthodontic treatment involving the teeth to be extracted
5. No past and present signs and symptoms of any periodontal disease
6. No past and present signs and symptoms of bruxism
7. No significant medical history that would affect the dentition
8. No craniofacial and dentoalveolar syndromes
9. Completed root formation
10. Knowledge of subject’s residence since birth and history on fluoride consumption.
11. Sufficient room for the proposed root movements to be carried out
Minimum age
12 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patient not requiring removal of bilateral first premolar teeth as part of orthodontic treatment.
2. History of dental/orthodontic treatment or trauma to the teeth to be extracted
3. Past and present signs and symptoms of any periodontal disease
4. Past and present signs and symptoms of bruxism
5. Any medical history that would affect the dentition
6. Any craniofacial and dentoalveolar syndromes
7. Inadequate root formation
8. Inadequate knowledge of subject’s residence since birth and history on fluoride consumption.
9. Insufficient room for the proposed root movements to be carried out

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients were enrolled and allocated to into the following four groups using a "Random Allocation Software" that produced a randomised list of group allocations across the 40 patients:

- Group LHJ (Light and Heavy Jiggling Movement Group)
- Group PCLJ (Positive Control Light and Light Jiggling Movement Group)
- Goup PCHJ (Positive Control Heavy and Heavy Jiggling Movement Group)
- Group HBIJ (Heavy Bucco-palatal and Vertical Jiggling Movement Group)

Within each group, coin tossing was used to determine which premolar (right or left) would be the control side and which tooth would be the intervention side (according to the title of the group).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation was done by a computer.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Following enrolment, patients were randomly allocated to one of four groups with the following parameters:

Group LHJ: Light and Heavy Jiggling Movement Group (Transverse): A randomly allocated left/right first premolar will undergo light jiggling movements, while the contralateral premolar will undergo heavy jiggling movements in the transverse plane.

Group PCLJ: Positive Control light (Unidirectional) and Light Jiggling Movement Group (Transverse): A randomly allocated left/right first premolar will undergo light unidirectional movements while the contralateral premolar will undergo light jiggling movements in the transverse plane.

Group PCHJ: Positive Control Heavy (Unidirectional) and Heavy Jiggling Movement Group (Transverse): The randomly allocated left/right first premolar will have heavy unidirectional movements while the contralateral premolar will have heavy jiggling movements applied.

Group HBIJ: Heavy Transverse and Vertical Jiggling Movement Group: The randomly allocated left/right first premolar will have heavy transverse jiggling movements while the contralateral premolar will have heavy vertical movements applied.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
5/04/2012
Actual
5/04/2012
Date of last participant enrolment
Anticipated
Actual
2/07/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 5803 0
Turkey
State/province [1] 5803 0
Samsun

Funding & Sponsors
Funding source category [1] 288660 0
Charities/Societies/Foundations
Name [1] 288660 0
Australian Society of Orthodontists Foundation for Research and Education
Country [1] 288660 0
Australia
Primary sponsor type
Individual
Name
Prof. M. Ali Darendeliler
Address
The University of Sydney
2/2 Chalmers Street
Surry Hills
NSW 2010
Country
Australia
Secondary sponsor category [1] 287370 0
Individual
Name [1] 287370 0
Dr Oyku Dalci
Address [1] 287370 0
The University of Sydney
2/2 Chalmers Street
Surry Hills
NSW 2010
Country [1] 287370 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290511 0
Zonguldak Karaelmas University Clinical Research Ethics Committee
Ethics committee address [1] 290511 0
Ethics committee country [1] 290511 0
Turkey
Date submitted for ethics approval [1] 290511 0
Approval date [1] 290511 0
20/03/2012
Ethics approval number [1] 290511 0
2012/06
Ethics committee name [2] 290512 0
Human Research Ethics Committee
Ethics committee address [2] 290512 0
Ethics committee country [2] 290512 0
Australia
Date submitted for ethics approval [2] 290512 0
Approval date [2] 290512 0
29/01/2014
Ethics approval number [2] 290512 0
2013/1095

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46018 0
A/Prof M. Ali Darendeliler
Address 46018 0
The University of Sydney
2/2 Chalmers Street
Surry Hills
NSW 2010
Country 46018 0
Australia
Phone 46018 0
+61 2 9351 8314
Fax 46018 0
Email 46018 0
[email protected]
Contact person for public queries
Name 46019 0
Oyku Dalci
Address 46019 0
The University of Sydney
2/2 Chalmers Street
Surry Hills
NSW 2010
Country 46019 0
Australia
Phone 46019 0
+61 2 9351 8314
Fax 46019 0
Email 46019 0
[email protected]
Contact person for scientific queries
Name 46020 0
Oyku Dalci
Address 46020 0
The University of Sydney
2/2 Chalmers Street
Surry Hills
NSW 2010
Country 46020 0
Australia
Phone 46020 0
+61 2 9351 8314
Fax 46020 0
Email 46020 0
[email protected]

No information has been provided regarding IPD availability


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.