Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001124123
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
12/08/2019
Date last updated
8/04/2022
Date data sharing statement initially provided
12/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
PET-B: Post Extraction use of TetraMax Part B (TMB). A comparator controlled clinical investigation comparing the bone healing capability of the investigational product "TetraMax plus BioOss" and the gold standard standard of care comparator "BioOssCollagen" (BioOssCol) for adults who have been treatment planned for tooth extraction/s and implant placement at the same extraction site/s.
Scientific title
PET-B: Post Extraction use of TetraMax Part B (TMB).. A comparator controlled clinical investigation comparing the bone healing capability of the investigational product "TetraMax plus BioOss" and the gold standard standard of care comparator "BioOssCollagen" (BioOssCol), for adults who have been treatment planned for tooth extraction/s and implant placement at the same extraction site/s.
Secondary ID [1] 298890 0
None
Universal Trial Number (UTN)
U1111-1237-8133
Trial acronym
PET-B
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healing and bone regeneration post-tooth extraction 313858 0
Condition category
Condition code
Musculoskeletal 312271 312271 0 0
Other muscular and skeletal disorders
Oral and Gastrointestinal 312273 312273 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 - TetraMax-B (TMB) or comparator control device (BioOss Collagen granules) by direct injection into the post-extraction dental socket. The approximate duration of the interventional procedure is 2 hours. All devices will be administered by an experienced dental implant surgeon and specialist periodontist. A maximum of 0.7ml of investigational product (TMB) (40% TetraMax 60% BioOss granules) will be applied. A maximum of 2.5ml of comparator control device BioOss Collagen will be applied. Total amount applied is dependent of dental socket dimensions.
Intervention code [1] 315160 0
Treatment: Devices
Comparator / control treatment
Active control via gold standard state of art approved BioOss Collagen medical device -available at the clinical trial sites per routine standard of care, Instructions for use available via download here: https://dental.geistlich-na.com/en-us/professionals/bone-substitutes/bio-oss-collagen/instructions-for-use/
Administered via direct injection into the tooth socket site, formed as part of natural tooth extraction operation, as per routine standard of care practice. Performed by an experienced dental implant surgeon and specialist periodontist. Required amount is used depending on the specific socket site in question.
Control group
Active

Outcomes
Primary outcome [1] 320906 0
Bone healing as assessed by CT imaging and histochemical analysis
Timepoint [1] 320906 0
16 weeks post tooth extraction
Secondary outcome [1] 373306 0
Soft tissue healing as assessed by visual observation by periodontist
Timepoint [1] 373306 0
16 weeks post tooth extraction
Secondary outcome [2] 373307 0
Evaluate the safety of TetraMax when combined with BioOss (TMB) per assessment of pain, swelling and infection at the treatment application site by periodontist.
Timepoint [2] 373307 0
16 weeks post tooth extraction
Secondary outcome [3] 373603 0
Evaluate the safety of TetraMax when combined with BioOss (TMB) per assessment of device malfunction reports.
Timepoint [3] 373603 0
At the time of use, which is time of tooth extraction

Eligibility
Key inclusion criteria
• Participants greater or equal to 18 years of age
• Participants who have been treatment planned for tooth extraction/s and implant placement at the same extraction site/s.
• Participants willing to give written informed consent and willing to participate in and comply with the investigation requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Participants <18 years of age.
• Participants with acute infection at the target site or a surgical site located near infection.
• Pregnant or lactating women, or women of childbearing potential who are not willing to avoid becoming pregnant during the study.
• Participants who are concurrently enrolled in another clinical study, or who have or received an investigational device or drug within the past four (4) weeks.
• Participants with a history of a psychological illness or condition such as to interfere with the Participant's ability to understand the requirements of the study.
• Participants unwilling or unlikely, in the Principal Investigator’s opinion, to comply with the study follow-up.
• Participants who are undergoing or are to undergo an immunosuppressive therapy.
• Participants with active cancer.
• Participants who have received radiation therapy to the jaws.
• Participants taking any drugs shown to alter bone metabolism within the jaws (e.g., bisphosphonates).

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)
The PI will determine if a subject is eligible for inclusion in the clinical investigation and if so, obtain required informed consent.
The PI will advise the sponsor that a clinical trial participant is available for inclusion in the clinical investigation.
The sponsor will randomise the clinical trial participant to the applicable treatment plan (investigational product TMB or SOC comparator BioOssCollagen) using a sealed opaque envelope concealment process.
The PI will be informed whether the participant has been assigned to a standard of care or investigational product treatment plan.
It is not possible to conceal the TMB versus comparator status from the PI for this clinical investigation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order for the allocation of subjects will be generated using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All data will be statistically evaluated by analysis of variance (ANOVA) followed by using SPSS PC 10 software (SPSS Inc.; Chicago, IL, USA). The level of significance will be set at p< 0.05..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
14/08/2019
Actual
19/08/2019
Date of last participant enrolment
Anticipated
22/03/2023
Actual
Date of last data collection
Anticipated
21/07/2023
Actual
Sample size
Target
43
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 14362 0
West Perth Periodontics - West Perth
Recruitment postcode(s) [1] 27360 0
6005 - West Perth

Funding & Sponsors
Funding source category [1] 303431 0
Commercial sector/Industry
Name [1] 303431 0
Tetratherix Technology Pty Ltd
Country [1] 303431 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Tetratherix Technology Pty Ltd
Address
Unit 29, 34-36 Ralph Street Alexandria New South Wales 2015 Australia
Country
Australia
Secondary sponsor category [1] 303482 0
None
Name [1] 303482 0
Address [1] 303482 0
Country [1] 303482 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303962 0
St Vincents Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 303962 0
41 Victoria Parade Fitzroy VIC 3065
Ethics committee country [1] 303962 0
Australia
Date submitted for ethics approval [1] 303962 0
06/03/2019
Approval date [1] 303962 0
24/06/2019
Ethics approval number [1] 303962 0
HREC 043/19

Summary
Brief summary
This is a two-stage clinical investigation.
Stage 1, an open label safety run-in investigation of the first three participants, who received open-label TetraMax in combination with BioOss (TMB) has been successfully completed. The first nine participants of stage 2 (randomisation) have received the IP/control product and are currently undergoing follow-up.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95394 0
A/Prof Dax Calder
Address 95394 0
West Perth Periodontics
21 Rheola Street
West Perth
WA 6005
Country 95394 0
Australia
Phone 95394 0
+61 893217581
Fax 95394 0
Email 95394 0
[email protected]
Contact person for public queries
Name 95395 0
Dr Ali Fathi
Address 95395 0
Tetratherix Technology Pty Ltd, Unit 29, 34-36 Ralph Street, Alexandria, NSW 2015, Australia
Country 95395 0
Australia
Phone 95395 0
+61 413721939
Fax 95395 0
Email 95395 0
[email protected]
Contact person for scientific queries
Name 95396 0
Dr Ali Fathi
Address 95396 0
Tetratherix Technology Pty Ltd, Unit 29, 34-36 Ralph Street, Alexandria, NSW 2015, Australia
Country 95396 0
Australia
Phone 95396 0
+61 413721939
Fax 95396 0
Email 95396 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Patient and company confidentiality


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.