Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000152628
Ethics application status
Approved
Date submitted
30/01/2014
Date registered
7/02/2014
Date last updated
18/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to estimate the changes in serum periostin levels in adult patients, following dental extractions with or without surgery.
Scientific title
A study to estimate the magnitude and time course changes in serum periostin levels in adult patients, following either simple tooth extraction, or tooth extraction involving surgery
Secondary ID [1] 284012 0
Nil known
Universal Trial Number (UTN)
U1111-1150-3950
Trial acronym
PER05
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Serum Periostin levels following dental extractions 291045 0
Condition category
Condition code
Oral and Gastrointestinal 291387 291387 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Serum Periostin levels
Serum Periostin levels will be measured at 7 time points: Baseline (up to 1 week prior to tooth extraction/surgery), Week 1, Week 2, Week 3, Week 4, Week 6 and Week 12 post extraction, via a specific periostin laboratory assay.
Intervention code [1] 288696 0
Not applicable
Comparator / control treatment
N/A - observational study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291382 0
Serum periostin levels over a 12 week period following dental extraction
Timepoint [1] 291382 0
Serum Periostin levels will be measured at 7 time points: Baseline (up to 1 week prior to tooth extraction/surgery), Week 1, Week 2, Week 3, Week 4, Week 6 and Week 12 post extraction, via a specific periostin laboratory assay.
Secondary outcome [1] 306639 0
Associations between serum periostin and non-asthmatic health conditions (as captured by general health questionnaire e.g. diabetes)
Timepoint [1] 306639 0
Baseline (up to 1 week prior to dental extraction/ surgery)

Eligibility
Key inclusion criteria
Aged between 18 to 75 years
Able to provide informed consent
Scheduled for dental extraction +/- surgery
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Doctor’s diagnosis of Asthma, Bronchitis or COPD
Wheezing or use of respiratory inhalers in the past 12 months
Known pregnancy
Significant co morbidities (determined at investigator discretion)
Hospital admission within last 3 months
Surgery within last 3 months, determined at investigator discretion (this includes all major surgery requiring general anaesthetic, dental extractions and root canal procedures. This does not include minor procedures, including but not limited to mole or wart removal, dental fillings etc).
Oral or Systemic Corticosteroids within the last 3 months
Any other safety concern at the investigator’s discretion

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
34 participants (in each group) are sufficient to detect a paired difference in periostin of 0.5 of a standard deviation with 80% power. The conventional interpretation of an effect size of 0.5 of a standard deviation is of a medium effect size. For a comparison between large and small dental procedures a sample size of 68 has a 90% power to detect a 0.8 standard deviation difference, a large effect size difference.
The periostin levels will be plotted against time and a non-parametric scatter plot smoother will be used to determine if there is a pattern of variation with time that might be usefully explored with parametric regression (e.g. linear, quadratic, cubic time terms). Paired t-test and mixed linear models will be used to compare the 12 week periostin level with measurements at the other times to formally compare the change with time.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/02/2014
Actual
3/03/2015
Date of last participant enrolment
Anticipated
30/06/2016
Actual
22/08/2016
Date of last data collection
Anticipated
15/11/2016
Actual
28/10/2016
Sample size
Target
68
Accrual to date
Final
68
Recruitment outside Australia
Country [1] 5789 0
New Zealand
State/province [1] 5789 0
Wellington

Funding & Sponsors
Funding source category [1] 288634 0
Commercial sector/Industry
Name [1] 288634 0
Genentech, Inc.
Country [1] 288634 0
United States of America
Primary sponsor type
Charities/Societies/Foundations
Name
Medical Research Institute of New Zealand
Address
Medical Research Institute of New Zealand
Level 7 CSB, Wellington Hospital
Riddiford Street
Newtown
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 287341 0
None
Name [1] 287341 0
Address [1] 287341 0
Country [1] 287341 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290489 0
Northern B HDEC
Ethics committee address [1] 290489 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 290489 0
New Zealand
Date submitted for ethics approval [1] 290489 0
Approval date [1] 290489 0
15/01/2014
Ethics approval number [1] 290489 0
13/NTB/187

Summary
Brief summary
Levels of POSTN (a protein-coding gene, also known as osteoblast specific factor) gene expression and periostin have been measured in a number of tissues and disease states. Periostin is associated with type I collagen in the periodontal ligament where it regulates the biomechanical properties of connective tissue around the tooth. Increased expression of the POSTN gene has been measured in the periodontal ligament on occlusal loading, investigators concluding that periostin is therefore essential for the integrity and function of the ligament. The serum levels of periostin following dental surgery have not yet been investigated.
This study of the magnitude and longitudinal changes in serum periostin levels in participants undergoing dental surgery endeavours to determine the clinical significance of periostin following dental surgery. Results from this study will provide a clearer picture of periostin production and further the development of periostin as a serum biomarker for asthma, as part of a programme of research being conducted at the Medical Research Institute of New Zealand.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45934 0
Prof Richard Beasley
Address 45934 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 45934 0
New Zealand
Phone 45934 0
+64 4 805 0147
Fax 45934 0
Email 45934 0
[email protected]
Contact person for public queries
Name 45935 0
Dr Rachel Caswell-Smith
Address 45935 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 45935 0
New Zealand
Phone 45935 0
+64 4 805 0247
Fax 45935 0
Email 45935 0
[email protected]
Contact person for scientific queries
Name 45936 0
Dr Rachel Caswell-Smith
Address 45936 0
Medical Research Institute of New Zealand Private Bag 7902, Wellington 6242
Country 45936 0
New Zealand
Phone 45936 0
+64 4 805 0247
Fax 45936 0
Email 45936 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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