Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000092392
Ethics application status
Approved
Date submitted
14/02/2008
Date registered
15/02/2008
Date last updated
15/02/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
chronOS Implant Evaluation Study. The Canberra Surgicentre and Synthes Australia are conducting a clinical study to evaluate the performance of chronOS granules (bone substitute) following the extraction of wisdom tooth/teeth to prevent the risk of periodontal defects.
Scientific title
To measure the efficacy of beta-TriCalcium Phosphate (TCP) bone graft filler in preventing periodontal defect on the distal aspect of the M2 following M3 extraction.
Secondary ID [1] 523 0
Not applicable
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mandibular M3 extraction may result in bony periodontal defects on the distal surface of the adjacent second molar. 2837 0
Dental health. 2838 0
Condition category
Condition code
Oral and Gastrointestinal 2969 2969 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 2970 2970 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
beta-TriCalcium Phosphate granules will be placed in the socket of one of the bilaterally extracted M3. After six months a first set of x-rays will be done to observe bone level at the cemento-enamel junction of the chronOS filled socket versus the non-filled socket. A second set of x-rays will be done at 12 months.
Intervention code [1] 2568 0
Not applicable
Comparator / control treatment
No treatment
Control group
Uncontrolled

Outcomes
Primary outcome [1] 3843 0
To prospectively determine using a non-randomized single blind controlled series whether subjects may benefit from periodontal healing after using a synthetic B-TCP bone graft material at the time of M3 extraction.
Timepoint [1] 3843 0
6 and 12 month follow up after operation.
Primary outcome [2] 3844 0
Prevention of peridontal defects.
Timepoint [2] 3844 0
18 months
Secondary outcome [1] 6478 0
Not applicable
Timepoint [1] 6478 0
Not applicable

Eligibility
Key inclusion criteria
Age >= 18 years
Removal of two mandibular M3
Mesioangular or horizontal M3 position
Agreement for return follow-up for at least 12 months.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Age < 18 years
No adjacent M2
Diabetic
Chronic steroid use.
Malignant condition
Previous radiotherapy to the maxilla or mandible.
Significant difference between the cementoenamel junction (CEJ) bilaterally, defined as attachment level variance of 1mm or more.

Study design
Purpose of the study
Prevention
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 774 0
2612

Funding & Sponsors
Funding source category [1] 3090 0
Self funded/Unfunded
Name [1] 3090 0
Canberra Surgicentre
Country [1] 3090 0
Australia
Primary sponsor type
Other
Name
Canberra Surgicentre
Address
11 Torrens Street
Braddon ACT 2612
Country
Australia
Secondary sponsor category [1] 2787 0
Commercial sector/Industry
Name [1] 2787 0
Synthes
Address [1] 2787 0
1 Lucknow Road
Riverside Corporate Park
North Ryde NSW 2113
Country [1] 2787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5038 0
Canberra Surgicentre Ethics committee
Ethics committee address [1] 5038 0
11 Torrens Street
Braddon ACT 2612
Ethics committee country [1] 5038 0
Australia
Date submitted for ethics approval [1] 5038 0
Approval date [1] 5038 0
04/06/2007
Ethics approval number [1] 5038 0

Summary
Brief summary
The primary purpose of this study is to confirm that chronOS (bone substitute) can decrease the risk of peridodontal defects following extraction of their wisdom tooth/teeth (M3) extraction.
It has been reported that by extracting the mandibular M3 bony peridontal defects can occur on the distal surface of the adjacent second molar. These bony defects are particularly present in patients who had their wisdom teeth extracted when over 26 years of age.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28375 0
Address 28375 0
Country 28375 0
Phone 28375 0
Fax 28375 0
Email 28375 0
Contact person for public queries
Name 11532 0
Hailey Cordina
Address 11532 0
11 Torrens Street
Braddon ACT 2612
Country 11532 0
Australia
Phone 11532 0
(02) 6276 3920
Fax 11532 0
Email 11532 0
[email protected]
Contact person for scientific queries
Name 2460 0
Alisa Stevenson
Address 2460 0
11 Torrens Street
Braddon ACT 2612
Country 2460 0
Australia
Phone 2460 0
(02) 6276 3920
Fax 2460 0
Email 2460 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.