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Trial registered on ANZCTR


Registration number
ACTRN12610000638033
Ethics application status
Approved
Date submitted
3/07/2010
Date registered
4/08/2010
Date last updated
4/08/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
A prospective randomised comparative study on the use of panoramic radiograph and cone beam scan with respect to the outcomes and incidence of inferior alveolar nerve injury after lower third molar removal, and establishing guidelines for the indications of cone beam scan as an adjunct to panoramic radiographs
Scientific title
A prospective randomised comparative study on the use of panoramic radiograph and cone beam scan with respect to the outcomes and incidence of inferior alveolar nerve injury after lower third molar removal, and establishing guidelines for the indications of cone beam scan as an adjunct to panoramic radiographs in patients with impacted lower third molars
Secondary ID [1] 252371 0
-
Universal Trial Number (UTN)
U1111-1114-8218
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Impacted Wisdom teeth 257258 0
Inferior Alveolar Nerve injury after third molar removal 257759 0
Condition category
Condition code
Oral and Gastrointestinal 257397 257397 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 participating in study (patients for lower wisdom teeth removal) will be randomised into two groups:
1- OPG (orthopantomogram) only as the preoperative imaging(gold standard)
2- OPG (orthopantomogram) and cone beam scan as the preoperative imaging
The intervention is: requesting an additional scan (Cone Beam Scan) of the third molar area
The duration of intervention is approximately 5-10 mins (ie the duration to set up and take a cone beam scan is ~5-10mins) - ONLY one scan ie one session.
Period of follow up is as per standard protocol for postoperative wisdom teeth follow up, that is: at 2 weeks postoperatively, if any concerns then at 3-4 weeks postop, if residual paraesthsia then 3months postop, then at 6months postop. If no paraesthesia and no problems after 2 weeks then patients are discharged.
Intervention code [1] 256379 0
Other interventions
Comparator / control treatment
Control group - patients who have orthopantomogram radiograph (gold standard preoperative imaging for patients having removal of wisdom teeth)
Because we are assessing to see if additional imaging changes surgical outcome, our control group is the group without the additional imaging, ie without the cone beam scan. These patients just have the orthopantomogram as the preoperative imaging assessement.
The orthopantomogram is essential for ANY patient to be assessed for third molar removal (regardless of whether they wish to participate in the study, its a necessity to have one prior to third molar removal), hence prior to consultation is when the "control is administered"; and they will only be "administered" once.
Again, duration of follow is as per intervention group, that is: standard post-op wisdom teeth follow up.
Period of follow up is as per standard protocol for postoperative wisdom teeth follow up, that is: at 2 weeks postop, if any concerns then at 3-4 weeks postop, if residual paraesthsia then 3months postop, then at 6mths postop. If no paraesthesia and no problems after 2 weeks then patients are discharged.
Control group
Active

Outcomes
Primary outcome [1] 258324 0
The primary outcome measured is the number of patients who have post-operative paraesthesia of the inferior alveolar nerve (known complication of wisdom teeth removal)

This is assessed clinical with: light touch, pin point assessment, and direction sense in the lower lip and chin
Timepoint [1] 258324 0
2weeks post-operatively
6months post-operatively
Secondary outcome [1] 264028 0
other complications of surgery-eg delayed healing

This is assessed clinically: see socket or surgical site that does not heal by the follow up visit, signs include: exposed bone, erythema, pain, swelling, inflammation
Timepoint [1] 264028 0
2 weeks post-operatively
3months post-operatively

Eligibility
Key inclusion criteria
Inclusion criteria for recruitment of patients is that of a convenience population – male and female patients over 18 years of age requiring lower wisdom teeth removal, who consent to participating in the study
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion critieria include: pregnant patients, patients incapable of consenting, patients wtih jaw pathology, preexisting paraesthesia, where on OPG the distance between the inferior alveolar nerve and lower third molar is >5mm

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
RECRUITMENT/ENROLLING IN STUDY:
Patient for removal of wisdom teeth have a consultation before procedure, during this consultation, the option of participation in study (discussion of pros/cons, risks) and possibly obtaining a Cone Beam Scan is discussed with patient, if they are happy to participate, they will be asked to sign a consent form and will randomly be allocated to a group -Control (ie. orthopantomogram only), or Intervention (ie. orthopantomogram and Cone beam scan).
They may pull out of the study at any stage, and it will not affect treatment.

RANDOMISATION PROCESS
Sealed envelopes containing a card reading "orthopantomogram only" or "orthopantomogram and Cone beam scan", will be shuffled and kept in a stack for random allocation. Sealed envelopes will be distributed at the front reception of the oral surgery department to new patients presenting for wisdom teeth consultation. The patient will be asked to give the envelope to the consulting clinician. During consultation and discussion with the patient, if the patient consents to participate in the study (and does not have any of the exclusion criteria above), the envelope will be opened which will allocate the patient to a study group. (Patients in the "orthopantomogram only" group – nothing further needs to be done; patients allocated to the "orthopantomogram and cone beam scan" group will be asked to obtain a cone beam scan from a radiology unit in Melbourne centre)
Patients who do no wish to participate, or for whom the study is not relevant, the envelope will remained sealed and be put in a tray. At the end of the day, these un-opened envelopes will be reviewed by the researcher who will review to see how many of orthopantomogram or orthopantomogram and cone beam allocations amongst these previous unopened envelopes of those who did not wish to participate. They will be discarded and replace with the same number of each allocation (to try and maintain a balance of 50:50 ratio of orthopantomogram: orthopantomogram and cone beam scan throughout the study).
The allocations are in sealed envelopes and distributed by the front desk reception. Once the patient agrees to the study and the envelope is opened, the patient bradma needs to be put on the allocation slip and then put in a box to be collected. This is to keep track of the allocations and avoid clinicians deciding on allocations.

Just to clarify that it will be distributed by reception, not shuffled by reception.
a random number generator on the computer calculator is used to decide the order of "orthopantomogram only" or "orthopantomogram and cone beam scan"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation sequence will be with the use of a computerised sequence generator (Stattrek - http://stattrek.com/Tables/Random.aspx )
even numbers: "orthopantomogram only"
odd numbers: "orthopantomogram and cone beam scan"
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
4000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 256883 0
Self funded/Unfunded
Name [1] 256883 0
Country [1] 256883 0
Primary sponsor type
Hospital
Name
Royal Dental Hospital Melbourne
Address
720 Swantson street, Carlton, 3053, Victoria
Country
Australia
Secondary sponsor category [1] 256156 0
University
Name [1] 256156 0
Univeristy of Melbourne, School of Dental Science
Address [1] 256156 0
720 Swantson street, Carlton, 3053, Victoria
Country [1] 256156 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258892 0
Human Research Ethics, Melbourne Research Office, The University of Melbourne
Ethics committee address [1] 258892 0
720 Swanston street, Carlton, 3053, Victoria
Ethics committee country [1] 258892 0
Australia
Date submitted for ethics approval [1] 258892 0
10/10/2009
Approval date [1] 258892 0
16/02/2010
Ethics approval number [1] 258892 0
HREC 0932551
Ethics committee name [2] 258893 0
Dental Health Services Australia (DHSV) ethics committee
Ethics committee address [2] 258893 0
720 Swanston street, Carlton, 3053, Victoria
Ethics committee country [2] 258893 0
Australia
Date submitted for ethics approval [2] 258893 0
03/06/2009
Approval date [2] 258893 0
03/08/2009
Ethics approval number [2] 258893 0
project 216

Summary
Brief summary
A known risk factor for lower wisdom teeth removal is inferior alveolar nerve injury, due to the anatomical position and relationship of these two structures.
Patients who are referred for wisdom teeth removal routinely have an orthopantomogram for preoperative assessment of these teeth. Cone beam scan, which is a low dose computed tomography scan providing 3-dimension representation of the site, is becoming increasingly popular for inferior alveolar nerve localization. However, there are no studies to show that additional scanning improves outcomes and decreases risk of post-operative numbness for the patient. Furthermore, there are currently no guidelines regarding clear indications for the use of cone beam scan as an adjunct.
This project will look at the incidence of postoperative altered inferior alveolar nerve sensation in patients who have lower wisdom teeth removed – in groups where they have the routine orthopantomogram radiograph only, and those who have, in addition to the orthopantomogram radiograph, a cone beam scan. The project will aim to establish evidence based guidelines for the use of Cone beam scan imaging as an adjunctive tool for third molar surgery.
Patients who agree to take part in the project will be randomised into two groups – the control is the group without additional imaging ("orthopantomogram only" group), and the intervention group is the group with the additional cone beam scan ("orthopantomogram and Cone beam scan" group).
The imaging will be examined with respect to the relationship between the inferior alveolar nerve and lower wisdom teeth.
During routine post-operative visits, patients are routinely monitored to establish the presence of inferior alveolar nerve injury. This data will be collected and analysed.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 31104 0
Address 31104 0
Country 31104 0
Phone 31104 0
Fax 31104 0
Email 31104 0
Contact person for public queries
Name 14351 0
Lee Kaing
Address 14351 0
Level 4, Oral Maxillofacial Surgery Department, Royal Dental Hospital Melbourne
720 Swanston street, Carlton, 3053, Victoria
Country 14351 0
Australia
Phone 14351 0
+61 413513186
Fax 14351 0
nil
Email 14351 0
[email protected]
Contact person for scientific queries
Name 5279 0
Lee Kaing
Address 5279 0
Level 4, Oral Maxillofacial Surgery Department, Royal Dental Hospital Melbourne
720 Swanston street, Carlton, 3053, Victoria
Country 5279 0
Australia
Phone 5279 0
+61 413513186
Fax 5279 0
nil
Email 5279 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.