Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001067066
Ethics application status
Not yet submitted
Date submitted
30/11/2010
Date registered
3/12/2010
Date last updated
3/12/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of mechanical vibration (Acceledent) on root resorption and the rate of tooth movement after application of orthodontic force. A micro-CT study.
Scientific title
Patients with crowded malocclusion requiring extraction of upper first premolar teeth as part of their orthodontic treatment will have Acceledent used on one side to compare the amount of root resorption and rate of tooth movement caused by orthodontic appliances.
Secondary ID [1] 253149 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Root resorption of teeth 258699 0
Condition category
Condition code
Oral and Gastrointestinal 258851 258851 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
Patients requiring upper 1st premolar extractions will have partial braces placed on the upper teeth to produce a buccally directed force on the upper 1st premolar teeth for 4 weeks. Acceledent is a new extraoral device that emits a low vibration force onto an attached mouthpiece. The mouth piece will be cut into half so that when placed in the mouth, only 1 side will feel the vibration force. During these 4 weeks, the patients will use Acceledent on one side only (randomly assigned) for 10 mins per day. After 4 weeks the upper first premolar teeth will be extracted and analysed with Micro CT for root resorption craters.
After extraction of the upper premolar teeth, full braces will be placed on the patient's teeth as part of their normal orthodontic treatment. Acceledent will continue to be used on one side to measure the rate of tooth movement with clinical measurements every 14 days and impression moulds every 28 days. The estimated measurement time for the rate of tooth movement is 3 months.
Intervention code [1] 257654 0
Treatment: Devices
Comparator / control treatment
All patients acted as their own controls. Control treatment will be the side which did not use Acceledent
Control group
Uncontrolled

Outcomes
Primary outcome [1] 259704 0
The sample will be analysed using a microcomputed tomography scan x-ray system, namely the SkyScan 1172 desktop x-ray micro-tomograph (SkyScan, Aartselaar, Belgium) . It enables the researcher to reconstruct the teeth in 3 dimensions as well as to reproduce slices. Once the resorption craters have been reconstructed, the internal parameters of the craters can be analysed and measured.
Timepoint [1] 259704 0
Records will be taken at the start of treatment at T-0. Patients will be seen every week for 4 weeks.
Secondary outcome [1] 266468 0
measurement of the rate of tooth movement
Timepoint [1] 266468 0
1) Initial phase 2 clinical records taken after upper 1st premolar extractions
2) Standardised dentition preparation procedure:
a. For initial alignment. (16 weeks).
b. Express the first, second and third order prescriptions. (8 weeks).
3) Vibration applied, using Acceledent.
a. Split mouth procedure (Side A & Side B ? randomly assigned per patient):
i. Side A [no vibration].
ii. Side B [vibration].
b. Vibration application protocol: 10 mins/day (Monday-Friday).
c. Vibration applied for a period of 3 months (12 weeks).
4) Clinical measurements taken every 14 days, and impressions taken every 28 days for the research period.

Eligibility
Key inclusion criteria
1. Need for bilateral upper first premolar extractions and fixed appliance orthodontic treatment;
2. Permanent Dentition;
3. No previous orthodontic or orthopaedic treatment;
4. No craniofacial anomaly present;
5. No previous reported or observed dental treatment of the maxillary canines;
6. No history of trauma, bruxism or parafunction;
7. No past and present signs and symptoms of periodontal disease;
8. No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement.
Minimum age
12 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Medically compromised patients
2. Patients with a history of poor compliance
3. Patients with active dental or gum disease
4. patients with poor oral hygiene
5. Patients that do not wish to volunteer for the study

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
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258122 0
Charities/Societies/Foundations
Name [1] 258122 0
Australian Society of Orthodontists
Country [1] 258122 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Australian Society of Orthodontists
Address
PO Box 576
Crows Nest NSW 1585
Australia
Country
Australia
Secondary sponsor category [1] 257299 0
None
Name [1] 257299 0
Address [1] 257299 0
Country [1] 257299 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 260124 0
Ethics committee address [1] 260124 0
Ethics committee country [1] 260124 0
Date submitted for ethics approval [1] 260124 0
08/12/2010
Approval date [1] 260124 0
Ethics approval number [1] 260124 0

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

Contacts
Principal investigator
Name 31942 0
Address 31942 0
Country 31942 0
Phone 31942 0
Fax 31942 0
Email 31942 0
Contact person for public queries
Name 15189 0
Daniel Tan
Address 15189 0
Discipline of Orthodontics, Sydney Dental Hospital,
2 Chalmers Street
Surrey Hills NSW 2010
Country 15189 0
Australia
Phone 15189 0
+61 2 92933388
Fax 15189 0
Email 15189 0
[email protected]
Contact person for scientific queries
Name 6117 0
Daniel Tan
Address 6117 0
Discipline of Orthodontics, Sydney Dental Hospital
2 Chalmers Street
Surrey Hills NSW 2010
Country 6117 0
Australia
Phone 6117 0
+61 2 92933388
Fax 6117 0
Email 6117 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.