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Trial registered on ANZCTR

Registration number

ACTRN12615000593538

Ethics application status

Approved

Date submitted

26/05/2015

Date registered

5/06/2015

Date last updated

6/06/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

The effects of micro-osteoperforations on orthodontic root resorption and tooth movement - A pilot study

Scientific title

The effect of micro-osteoperforations into the alveolar bone versus no micro-osteopeforations on root root resorption and rate of tooth movement in patients who require upper premolar extractions as part of their overall orthodontic treatment plan

Secondary ID [1]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

orthodontic root resorption

Condition category

Condition code

Oral and Gastrointestinal

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

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The study involves participants who require upper premolar extractions as part of their overall orthodontic treatment plan.
First part:
The first part of the project involves placing orthodontic braces only on the upper posterior teeth. Using a split-mouth design, one side will be randomly made control, while the other will be the experimental side in which micro-osteoperforations will be placed. Micro-osteoperforations involves the placement of a series of small punctures through the gingiva and alveolar bone associated with the roots of teeth to stimulate a localized inflammatory process. A specialized instrument designed specifically for micro-osteoperforations will be used.
Three perforations 3-7mm deep in a vertical alignment will be placed on both the mesial and distal aspects of the upper first premolar. Including the anaesthetic administration, the micro-osteoperforation procedure would take approximately 30 minutes.
Using partial braces on the upper posterior teeth (first and second premolar and first molar), orthodontic force will be applied to the first premolars bilaterally for 4 weeks, after which the teeth will be extracted as part of the patient’s ongoing orthodontic treatment. These extracted teeth will then be scanned with a MicroCT scanner and the extent of resorption measured. Patients will also be asked to record their level of discomfort on the experimental and control side following the placement of braces and micro-osteoperforations.
Second part:

The second part of the study involves placing full braces on the subjects. This will take place around 2 weeks after the extractions of the premolars and conclusion of the first part of the study. It will involve 24 weeks of aligning and levelling teeth. After this period, another three perforations in a vertical alignment will be placed distal to the upper canine on the experimental side and the rate of canine retraction will be compared to the control side. Patients will be assessed and tooth movement measured off study models every 2-4 weeks, over an 8-week period.

Intervention code [1]

Treatment: Surgery

Intervention code [2]

Treatment: Devices

Comparator / control treatment

The control would be the randomly selected side of the mouth where there will be no micro-osteoperforations.
First part:
Like the intervention side, an orthodontic force will be placed to move the upper first premolar buccally (towards the cheek) for 4 weeks, after which the premolar would be extracted and examined under Micro-CT to assess extent of root resorption. Second part:
The rate of orthodontic space closure of the first premolar extraction space at the control side would also compared with the intervention side.

Control group

Active

Outcomes

Primary outcome [1]

Amount of orthodontic root resorption. The premolar roots will be scanned with a MicroCT scanner and the extent of root resorption measured.

Timepoint [1]

4 weeks post orthodontic forces

Secondary outcome [1]

Orthodontic tooth movement. This will be measured clinically inside the mouth every 2 weeks for 8 weeks, and also from models from impressions of the teeth.

Timepoint [1]

32 weeks after commencement of orthodontic treatment

Eligibility

Key inclusion criteria

Need for bilateral maxillary first premolar extractions (necessitating moderate anchorage requirements) and fixed appliance treatment;
Permanent Dentition;
Apexification (root formation) completed;
Similar degree of minimal crowding on each side of the maxillary arch

Minimum age

12 Years

Maximum age

18 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Previous orthodontic or orthopaedic treatment;
Craniofacial anomaly present;
Previous reported or observed dental treatment of the maxillary canines;
History of trauma, bruxism or parafunction;
Past and present signs and symptoms of periodontal disease;
Significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement.

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 will be recruited from the orthodontic waiting list at Sydney Dental Hospital.
The Orthodontic Department routinely screens patients to assess whether they have an orthodontic problem that requires treatment. The patient is placed on the appropriate waiting list if the quality for treatment.
Patients with a specific orthodontic problem (maxillary protrusion or bimaxillary protrusive and severe crowding) are selected from the waiting list.
These patients are sent a letter from the Head of Department inviting their participation in the study. These patients are asked to attend for an examination to screen for eligibility for the study, if they meet the criteria, they are then invited to participate in the research project.
When interested patients attend for screening, they are asked to complete the Participant Consent Form before any screening procedures are undertaken.
If the patients are ineligible for the study, they will commence their routine clinical care immediately and will not be returned to the waiting list.
Allocation is not concealed due to the split-mouth design of the study (one side of the mouth would be randomly assigned to be experimental and the other side would be assigned as control). However, as the same operator is going to place the micro-osteoperforations and examine the root resorption, the extracted premolars will be given a random de-identification number which will be stored on master spread sheet. This will be done to prevent the operator from knowing which tooth was experimental or control.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Sides of mouth would be randomly assigned as experimental or control via coin toss (heads and tails allocated as right and left).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

20/07/2015

Actual

1/10/2015

Date of last participant enrolment

Anticipated

30/06/2016

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Sydney Dental Hospital - Surry Hills

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Department of Orthodontics, Sydney Dental Hospital

Address [1]

2 Chalmers St
Surry Hills NSW 2010

Country [1]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Australian Society of Orthodontics Foundation for Research and Education

Address

Level 3, 33-35 Atchison Street
St Leonards NSW 2065

Country

Australia

Secondary sponsor category [1]

Commercial sector/Industry

Name [1]

Pacific Orthodontics

Address [1]

Pacific Orthodontics Pty Ltd
P.O. Box 885
Kenmore, Brisbane
QLD 4069
AUSTRALIA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

SLHD Ethics Review Committee (RPAH Zone)

Ethics committee address [1]

Research Development Office Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/05/2015

Approval date [1]

14/08/2015

Ethics approval number [1]

EC00113

Summary

Brief summary

A primary objective of orthodontic treatment is to achieve a functional and aesthetic outcome efficiently and with minimum root resorption.  Preliminary research has shown promising results with micro-osteoperforations and accelerated orthodontic tooth movement.  Being a relatively recent adjunct to orthodontic treatment, further research is required to gain insight into the effects of micro-osteoperforation on tooth movement as well as on root resorption.

The aim of the proposed investigation is twofold.  The first part consists of applying buccally directed orthodontic forces to the upper 1st premolars to compare the amount of root resorption that occurs with normal orthodontic tooth movement, with that which occurs with orthodontic tooth movement in areas treated with micro-osteoperforations.  The micro-osteoperforations will be applied using a disposable appliance designed for this purpose by Propel Orthodontics.  The Propel device is a TGA approved, FDA registered medical device specifically designed to create micro-osteoperforations.  The second part consists of quantitatively measuring the rate of bodily canine retraction with normal orthodontic tooth movement, and orthodontic tooth movement associated with micro-osteoperforations.  The hypothesis of this research project is that micro-osteoperforations will minimise orthodontic root resorption while allowing accelerated rates of orthodontic tooth movement. 

The proposed investigation will be a Prospective Cohort study involving 12-14 subjects.  The first part of the project involves placing orthodontic braces only on the upper posterior teeth.  Using a split-mouth design, one side will be randomly made control, while the other will be the experimental side in which micro-osteoperforations will be placed.  Three perforations in a vertical alignment will be placed on both the mesial and distal aspects of the upper first premolar.  Orthodontic force will be applied to the first premolars bilaterally for 4 weeks, after which the teeth will be extracted as part of the patient’s ongoing orthodontic treatment.  These extracted teeth will then be scanned with a MicroCT scanner and the extent of resorption measured.  Patients will also be asked to record their level of discomfort on the experimental and control side following the placement of braces and micro-osteoperforations.  

The second part of the study involves placing full braces on the subjects with 24 weeks of aligning and levelling teeth.  After this period, another three perforations in a vertical alignment will be placed distal to the upper canine on the experimental side and the rate of canine retraction will be compared to the control side.  Patients will be assessed and tooth movement measured off study models every 2-4 weeks, over an 8-week period.  

Conclusion:
Root resorption is a significant consequence of orthodontic treatment.  As micro-osteoperforations is a new adjunctive treatment to orthodontics, further research is needed to assess its effect on root resorption and to confirm its association with accelerated orthodontic tooth movement.

Trial website

Trial related presentations / publications

Public notes

Attachments [1]

/AnzctrAttachments/368641-Microosteoperforations ethics application.doc

Attachments [2]

/AnzctrAttachments/368641-RESEARCH PROTOCOL.docx

Contacts

Principal investigator

Name

Prof M. Ali Darendeliler

Address

Sydney Dental Hospital
2 Chalmers St
Surry Hills NSW 2010

Country

Australia

Phone

+612 9351 8314

Fax

ali.darendeliler@sydney.edu.au

Contact person for public queries

Name

Emmanuel Chan

Address

Sydney Dental Hospital
2 Chalmers St
Surry Hills NSW 2010

Country

Australia

Phone

+612 9351 8314

Fax

emmanuel.y.chan@gmail.com

Contact person for scientific queries

Name

Emmanuel Chan

Address

Sydney Dental Hospital
2 Chalmers St
Surry Hills NSW 2010

Country

Australia

Phone

+612 9351 8314

Fax

emmanuel.y.chan@gmail.com

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

Source	Title	Year of Publication	DOI
Embase	Effectiveness of minimally invasive surgical procedures in the acceleration of tooth movement: a systematic review and meta-analysis.	2016	https://dx.doi.org/10.1186/s40510-016-0146-9

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically