Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000027516
Ethics application status
Approved
Date submitted
16/12/2014
Date registered
19/01/2015
Date last updated
28/10/2022
Date data sharing statement initially provided
28/10/2022
Date results information initially provided
28/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Single centre, open-label, pilot study of Celgro(tm) collagen membrane for guided bone regeneration around exposed implants in patients undergoing dental implant surgery
Scientific title
Single-centre, open-label, pilot study of Celgro(tm) collagen membrane for guided bone regeneration around exposed dental implants in patients undergoing dental implant surgery
Secondary ID [1] 285860 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental implants 293774 0
Condition category
Condition code
Oral and Gastrointestinal 294078 294078 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 who are undergoing dental implant surgery with bone augmentation will receive Celgro(tm) collagen membrane as a part of the bone augmentation procedure instead of a commercially-available collagen membrane. The membrane is placed in the jaw during implant placement surgery, which is a single occasion.
Intervention code [1] 290841 0
Treatment: Devices
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293862 0
Measurement of bone regeneration and healing by CBCT scan
Timepoint [1] 293862 0
6 months post-treatment
Primary outcome [2] 293863 0
Adverse events related to study treatment or procedures. The investigator will perform a full dental examination at each visit and participants will be questioned regarding any adverse events occurring between study visits. Potential adverse events related to the investigational product include infection of the surgical site due to membrane exposure to the oral cavity and allergic reaction to the Celgro product. Potential adverse events related to the dental surgery include pain, swelling, infection and slight bleeding at the surgical site.
Timepoint [2] 293863 0
Up to 6 months post-treatment
Secondary outcome [1] 312026 0
Wound healing assessment. The wound will be visually assessed by the investigator and the presence of soft tissue dehiscence, membrane exposure, swelling, inflammation, fibrin, plaque and necrosis recorded.
Timepoint [1] 312026 0
1 week, 1 month and 6 months post-treatment
Secondary outcome [2] 312027 0
Maximum pain score since the previous visit using a scale of 1-10 where 1 = no pain to 10 = worst pain
Timepoint [2] 312027 0
1 week and 1 month post-treatment

Eligibility
Key inclusion criteria
- Participant requires one or more dental implants with simultaneous bone augmentation procedure
- Tooth extraction procedure was performed prior to simultaneous augmentation procedure with no complications
- Female participants of child-bearing potential must:
*Have a negative pregnancy test within 72 hours of visit 1
*Agree not to fall pregnant while on the study
- Non-smoker
- Able to comply with the requirements of the protocol, including post-operative oral hygiene and attendance for follow-up procedures
- Able to give informed consent or has legally acceptable representative who can give informed consent in accordance with ICH/GCP
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Insulin-dependent, uncontrolled or poorly-controlled diabetes mellitus
- History of malignancy, radiotherapy or chemotherapy within the last 5 years
- Female participant who is pregnant or lactating
- Participant is taking medication that may have an effect on bone turnover or mucosal healing
- General contraindications for dental and/or surgical treatment
- Concurrent disease or medical condition which affects bone or connective tissue metabolism
- Known hypersensitivity to collagen
- Known substance abuse
- Participation in another study with an investigational product within previous 3 months
- Other clinically significant disease (including psychological disorders) or medical condition that would, in the opinion of the investigator, compromise the safety or the participant or the outcome of the study

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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2015
Actual
10/07/2015
Date of last participant enrolment
Anticipated
1/06/2018
Actual
13/09/2018
Date of last data collection
Anticipated
Actual
18/06/2019
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 290435 0
Commercial sector/Industry
Name [1] 290435 0
Orthocell Ltd
Country [1] 290435 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Orthocell Ltd
Address
Building 191
Murdoch University
South Street
Murdoch WA 6150
Country
Australia
Secondary sponsor category [1] 289146 0
None
Name [1] 289146 0
Address [1] 289146 0
Country [1] 289146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292115 0
St John of God Health Care HREC
Ethics committee address [1] 292115 0
12 Salvado Road
Subiaco WA 6009
Ethics committee country [1] 292115 0
Australia
Date submitted for ethics approval [1] 292115 0
29/12/2014
Approval date [1] 292115 0
11/02/2015
Ethics approval number [1] 292115 0
761

Summary
Brief summary
Tooth extraction or loss results in resorption of bone volume in the jaw. This is a natural phenomenon which occurs mainly during the first 3 months following removal of the tooth. Preservation of bone volume facilitates subsequent placement of dental implants and leads to improved functional and aesthetic outcomes for patients.

Guided bone regeneration (GBR) is a commonly used technique where a bone substrate (autologous or de-proteinised bovine bone matrix) is packed around the exposed implant to fill the defect, and covered with a membrane. The membrane promotes the growth of new bone by occluding infiltration of competing soft tissue, but permitting fluid and nutrient transfer to the newly forming bone. Native collagen membranes of porcine origin are commonly used as they have been proven to significantly enhance periodontal and bone regeneration in animal and human clinical studies.

Celgro(tm) is an acellular type I/III collagen matrix of porcine origin. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin.

Celgro(tm) is a next-generation membrane that is manufactured using collagen originating from animals bred and exclusively raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of Celgro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type.

This study proposes to use Celgro(tm) in a standardised dental implantation procedure to assess its suitability for use in GBR.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53594 0
Dr Brent Allan
Address 53594 0
St John of God Hospital
c/o 28 McCourt Street
West Leederville
WA 6007
Country 53594 0
Australia
Phone 53594 0
+61 08 9388 3999
Fax 53594 0
Email 53594 0
drbpallan@bigpond.com
Contact person for public queries
Name 53595 0
Dr Brent Allan
Address 53595 0
St John of God Hospital
c/o 28 McCourt Street
West Leederville
WA 6007
Country 53595 0
Australia
Phone 53595 0
+61 08 9388 3999
Fax 53595 0
Email 53595 0
drbpallan@bigpond.com
Contact person for scientific queries
Name 53596 0
Dr Clair Lee
Address 53596 0
Clinical Research Manager

Orthocell Ltd
Building 191
Murdoch University
South Street
WA 6150
Country 53596 0
Australia
Phone 53596 0
+61 08 9360 2888
Fax 53596 0
Email 53596 0
clair.lee@orthocell.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified line listings/summary data.
When will data be available (start and end dates)?
After final publication, no end date.
Available to whom?
Researchers with a scientifically and methodologically sound research proposal, which has been approved by a Human Research Ethics Committee, as assessed on a case-by-case basis.
Available for what types of analyses?
Meta-analysis.
How or where can data be obtained?
Subject to approval from the PI and Sponsor.

Email: luke.hanrahan@orthocell.com.au


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.