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Trial registered on ANZCTR


Registration number
ACTRN12617001279314
Ethics application status
Approved
Date submitted
17/08/2017
Date registered
6/09/2017
Date last updated
24/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Clinical Trial Assessing TrimphDent Application in Adult Patients Undergoing Routine Tooth Extraction
Scientific title
A pilot study to evaluate feasibility of TrimphDent Application in Adult Patients Undergoing Routine Tooth Extraction
Secondary ID [1] 292641 0
None
Universal Trial Number (UTN)
Trial acronym
PET
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tooth extraction. 304372 0
Condition category
Condition code
Oral and Gastrointestinal 303702 303702 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
Single application of experimental device, TrimphDent, by injection. TrimphDent is an injectable biomaterial consisting of a synthetic polymer and peptide, Thymosin B4, chemically bonded to create a single uniform molecule.
Between 0.5ml and 2ml of TrimphDent will be injected to fill the empty dental socket immediately after tooth-extraction. The amount of TrimphDent to be injected (i.e. between 0.5ml and 2ml) is dependent on the size of the empty dental socket and this is based on clinical judgment. Application of TrimphDent will be performed by an experienced Dental Implant Surgeon and Specialist Periodontist. It is expected that TrimphDent will remain in-situ permanently as it stimulates and interfaces with both tissue regeneration.
Intervention code [1] 298875 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303066 0
Performance of TrimphDent in stimulating new bone regeneration following tooth extraction. Measured by presence of bone mineralisation and inflammatory responses by bone histology and CT examination.
Timepoint [1] 303066 0
3 months post TrimphDent application
Primary outcome [2] 303155 0
Performance of TrimphDent in reducing post-operative infection following oral surgery. Measured by examination of the target tissue by oral and histological examination as well as CT imaging.
Timepoint [2] 303155 0
7 days post TrimphDent application and 3 months post TrimphDent application
Secondary outcome [1] 337816 0
Safety of TrimphDent for use in oral and maxillofacial surgeries to facilitate hard and soft tissue formation. Adverse Events (AE) and Serious Adverse Event (SAE) assessment. Possible adverse events/reactions include:
* Seroma, haematoma or infection at the extraction site.
* Tenderness or redness at the extraction site.
* Swelling, fluid collection, infection of soft tissue or bone (osteomyelitis)
* Osteolysis
* Ectopic and/or exuberant bone formation
* Foreign body/allergic reaction
* Incisional complications
* Nonunion, malunion or delayed union
* Damage to nearby tissue
* Neurological system compromise
* Pain and discomfort
* Scar formation
Possible adverse events/reactions will be assessed by clinical interview, oral examination, CT evaluation and bone histology.
Timepoint [1] 337816 0
From time of TrimphDent application through to 3 months post application of TrimphDent.
Secondary outcome [2] 338054 0
Examination of in vivo characteristics of TrimphDent in humans using oral examination, CT-evaluation and bone histology.
Timepoint [2] 338054 0
From time of TrimpDent application through to 3 months post TrimphDent application.

Eligibility
Key inclusion criteria
- Patients greater than 18 years of age.
- Patients undergoing a planned tooth extraction.
- Patients willing to give written informed consent and willing to participate and comply with the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with chronic inflammation as assessed by clinical laboratory assessments.
- Patients with low liver function as assessed by clinical laboratory assessments.
- Patients with low kidney function as assessed by clinical laboratory assessments.
- Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
- Patients with a history of disease that is likely to interfere with the normal post-operative healing process.


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
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
As this is a pilot study of an investigational product, there will be no statistically powered endpoints that will be tested, Descriptive statistical tools will be used to describe data which will be qualitatively assessed against an historical (literature) control population.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 297269 0
Commercial sector/Industry
Name [1] 297269 0
Trimph Industries Pty Ltd
Address [1] 297269 0
T4/125
National Innovation Centre
4 Cornwallis Street
Eveleigh 2015
NSW
Country [1] 297269 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Trimph Industries Pty Ltd
Address
T4/125
National Innovation Centre
4 Cornwallis Street
Eveleigh 2015
NSW
Country
Australia
Secondary sponsor category [1] 296246 0
None
Name [1] 296246 0
Address [1] 296246 0
Country [1] 296246 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298387 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 298387 0
Ethics committee country [1] 298387 0
Australia
Date submitted for ethics approval [1] 298387 0
Approval date [1] 298387 0
20/01/2017
Ethics approval number [1] 298387 0

Summary
Brief summary
TrimphDent is an injectable biomaterial for use in dental and maxillofacial applications. TrimphDent consists of two components: (1) the Trimph smart synthetic polymer and (2) a peptide (Thymosin B4). The use of TrimphDent as a regenerative scaffold is aimed to:
a) stimulate new bone regeneration following tooth extraction.
b) negate the need for bone harvesting operations or other bone grafting procedures following tooth extraction
c) reduce post-operative infections risks following oral surgery.

This initial pilot study will enrol ten (10) patients from one (1) centre in Western Australia, The study is being conducted in conjunction with standard of care procedures in patients undergoing tooth extraction with subsequent planned dental implant procedure.

The primary objective of this pilot study is to identify qualitative measures and analytical methodologies to further investigator the use of TrimphDent. This will be done using three methods including: oral examination, histological evaluation and CT-imaging. These methodologies will be utilised to evaluate bone regeneration in the presence of TrimphDent following tooth extraction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76918 0
A/Prof Dax Calder
Address 76918 0
West Perth Periodontics
21 Rheola Street
West Perth
WA 6005
Country 76918 0
Australia
Phone 76918 0
+ 61 8 9321 7581
Fax 76918 0
Email 76918 0
dcalder@optusnet.com.au
Contact person for public queries
Name 76919 0
Dr Ali Fathi
Address 76919 0
Trimph Industries Pty Ltd
T4/125 National Innovation Centre
4 Cornwallis Street
Eveleigh 2015
NSW
Country 76919 0
Australia
Phone 76919 0
+ 61 413 721 939
Fax 76919 0
Email 76919 0
ali.fathi@trimph.com.au
Contact person for scientific queries
Name 76920 0
Dr Ali Fathi
Address 76920 0
Trimph Industries Pty Ltd
T4/125 National Innovation Centre
4 Cornwallis Street
Eveleigh 2015
NSW
Country 76920 0
Australia
Phone 76920 0
+ 61 413 721 939
Fax 76920 0
Email 76920 0
ali.fathi@trimph.com.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary