Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000190505
Ethics application status
Approved
Date submitted
26/08/2023
Date registered
27/02/2024
Date last updated
27/02/2024
Date data sharing statement initially provided
27/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The clinical effects of the adjunctive use of a viscoelastic gel containing hyaluronic acid and polynucleotides with deproteinised bovine bone mineral and collagen matrix in alveolar ridge preservation: A Pilot Randomised Controlled Clinical Trial
Scientific title
The clinical effects of the adjunctive use of a viscoelastic gel containing hyaluronic acid and polynucleotides with deproteinised bovine bone mineral and collagen matrix in alveolar ridge preservation: A Pilot Randomised Controlled Clinical Trial
Secondary ID [1] 310231 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tooth extraction 330930 0
Condition category
Condition code
Oral and Gastrointestinal 327729 327729 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
To compare the clinical efficacy of a new biological agent Regenfast [viscoelastic gel containing hyaluronic acid (HA) and polynucleotides (PN)] into alveolar ridge preservation biomaterials: deproteinised bovine bone mineral with 10% collagen (DBBM-C) and collagen matrix into extraction sockets.

250mg of DBBM-C soaked in 0.6ml viscoelastic gel for 5 minutes prior to placement into a single extraction socket (single administration) in each participant. The product will be soaked and administered by the primary clinician (Periodontist- Dr, A,J-L)
Intervention code [1] 326623 0
Treatment: Drugs
Comparator / control treatment
Control: Just the use of alveolar ridge preservation biomaterials: Deproteinised bovine bone mineral with 10% collagen (DBBM-C) and collagen matrix placed in extraction socket.

250mg of DBBM-C soaked in saline solution and placed into extraction socket by the same primary clinician (Periodontist- Dr A.J-L).
Control group
Active

Outcomes
Primary outcome [1] 335507 0
Efficacy of adding viscoelastic gel to ARP biomaterials measured through:
Quantitative measurements (hard-tissue) [Composite outcome]
a) Bucco-lingual horizontal ridge width changes at 1, 3, and 5mm below the alveolar ridge crest using a cone-beam computed tomography (CBCT).
b) Vertical height changes in the buccal (VHB) and palatal (VHP) alveolar ridge crest (VHB and VHP, respectively), using CBCT.
Timepoint [1] 335507 0
At baseline and at 16 weeks post-procedure
Primary outcome [2] 336998 0
Efficacy of adding viscoelastic gel to ARP biomaterials measured through:
Quantitative measurements of horizontal soft tissue thickness on the buccal aspect (“1mm from crest”) and vertical soft tissue thickness through the use of ultrasonography (Composite outcome)
Timepoint [2] 336998 0
At baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, and 16 weeks post-procedure
Secondary outcome [1] 424887 0
Soft tissue healing outcomes are measured through the:
o Quantitative rate of healing (% of socket closure over time based on sequential photographs OR M-D and B-L dimension changes over time).
Timepoint [1] 424887 0
1,2,4,8,12,and 16 weeks post procedure
Secondary outcome [2] 430345 0
Soft tissue healing outcomes are measured through the:
Assessment of healing based on the Landry et al. wound healing index at each time point
Timepoint [2] 430345 0
1,2,4,8,12, 16 weeks post-procedure
Secondary outcome [3] 430346 0
Patient-related outcomes (pain, quality of life, willingness to undergo the same type of surgery again) assessed as a composite outcome obtained through patient questionnaires using VAS scores and Oral Health Impact Profile (OHIP-14).
Timepoint [3] 430346 0
1,2,4,8,12, and 16 weeks post-procedure

Eligibility
Key inclusion criteria
Patient-specific inclusion criteria
• Age greater than or equal to 21 years old
• Females and Males
• Systemic and local conditions compatible with implant placement and experimental procedures
• Patient willing and fully capable of complying with the study protocol.

Tooth and site-specific inclusion criteria
To be considered the tooth site will have to fulfil all the following criteria:
• Terminal prognosis of a single-rooted incisor, canine or premolar tooth requiring extraction.
• Extraction may be indicated due to trauma, endodontic complication (root fracture) or unrestorable caries.
• Periodontal status: adequate oral hygiene, Bleeding on probing <20%, Plaque index < 20%
• Single tooth extraction with no missing adjacent teeth.
• Accepted characteristics of an extraction socket site:
o Buccal socket wall with >50% of the buccal bone height is present.
o Sufficient space is required for implant placement.
Minimum age
21 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient-specific exclusion criteria
• Current heavy smoking (>10 cigarettes/day for >6 months prior to and at the time of the surgical procedure)
• Patients with uncontrolled diabetes: defined as HbA1c >7.0
• Severe hematologic disorders, such as haemophilia or leukemia
• Liver or kidney failure
• History of radiation therapy in the head and neck area
• History of chemotherapy
• Systemic disease or conditions with a documented effect on bone metabolism and/or osseous healing
• Past (within 6 months prior to enrolment in the study) or current treatment with any medication with a documented effect on bone metabolism and/or osseous healing
• Documented allergy to dental materials involved in the experimental protocol
• Pregnancy or lactation
• Chronic drug abuse
• Psychological disorders: mental disabilities that may interfere with reading, understanding and signing the informed consent and/or with following study-related instructions.

Moreover, participants immediately exited the study upon:
• Request to withdraw from further participation
• Development of acute dental, peri-implant or oral conditions requiring treatment
• Development of conditions conflicting with the inclusion criteria listed above.
• Failure to comply with study instructions/requirements.

Site-specific exclusion criteria:
• Missing adjacent teeth
• Buccal socket wall with more than 3mm or 25% of the coronal mid-buccal vertical wall lost.
• Site with acute infection (i.e pain or presence of abscess).

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)
Once the patients have been identified to be suitable for the study by the examiner Dr. C.S. A periodontist not involved in the study will use a simple randomisation table created by a computer software to allocate the patients into one of the two groups. The treatment to be received by the patient will be concealed in an opaque envelope with their name labelled clearly on the front. This envelope will only be provided to the surgeon periodontist (Dr. A.J-L) on the day of treatment. The examiner Dr. C.S will remain blinded to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation) will be completed by an individual that is not involved in the research but is part of the teaching staff of the University of Western Australia.
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
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size:
As this is a pilot study, 10 control and 10 test participants will be enrolled. However, this number of participants is underpowered as 21 experimental subjects and 21 control subjects are required to be able to reject the null hypothesis based on a study done by Macbeth and colleagues.

The data will be analysed using IBM SPSS Statistics. To evaluate the differences in soft tissue linear and volumetric measurements between groups, a one-way ANOVA test was utilised to allow for different variances. Additionally, the changes in soft tissue thickness in each treatment group after 4 months will be compared to the baseline measurements. To control for false discovery, all p-values will be adjusted using the false discovery rate (FDR) method. The significance threshold will be set at 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
8/03/2024
Actual
Date of last participant enrolment
Anticipated
15/07/2024
Actual
Date of last data collection
Anticipated
31/07/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 25350 0
Oral Health Centre Western Australia - Nedlands
Recruitment postcode(s) [1] 40963 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 314390 0
University
Name [1] 314390 0
The University of Western Australia
Country [1] 314390 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
17 Monash Avenue, Nedlands, 6009, WA
Country
Australia
Secondary sponsor category [1] 316381 0
None
Name [1] 316381 0
Address [1] 316381 0
Country [1] 316381 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313484 0
Human Research Ethics Committee (HREC) of University of Western Australia
Ethics committee address [1] 313484 0
Ethics committee country [1] 313484 0
Australia
Date submitted for ethics approval [1] 313484 0
04/08/2023
Approval date [1] 313484 0
13/02/2024
Ethics approval number [1] 313484 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128330 0
A/Prof Leticia Algarves Miranda
Address 128330 0
Associate Professor Leticia Algarves Miranda, University of Western Australia 17, Monash Avenue Nedlands, 6009 WA
Country 128330 0
Australia
Phone 128330 0
+61 8 6457 7894
Fax 128330 0
Email 128330 0
[email protected]
Contact person for public queries
Name 128331 0
Leticia Algarves Miranda
Address 128331 0
Associate Professor Leticia Algarves Miranda, University of Western Australia 17, Monash Avenue Nedlands, 6009 WA
Country 128331 0
Australia
Phone 128331 0
+61 8 6457 7894
Fax 128331 0
Email 128331 0
[email protected]
Contact person for scientific queries
Name 128332 0
Leticia Algarves Miranda
Address 128332 0
Associate Professor Leticia Algarves Miranda, University of Western Australia 17, Monash Avenue Nedlands, 6009 WA
Country 128332 0
Australia
Phone 128332 0
+61 8 6457 7894
Fax 128332 0
Email 128332 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The quantitative and qualitative measurements obtained from the clinical trial. All results are de-identified and participants will not be identifiable.
When will data be available (start and end dates)?
Immediately following publication with no end date determined at this stage.
Available to whom?
case-by-case basis at the discretion of the primary investigator and researcher
Available for what types of analyses?
Quantitative and qualitative analyses
How or where can data be obtained?
Access subject to approval by Principal Investigator A/Prof Leticia Algarves Miranda. ([email protected])


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.