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Trial registered on ANZCTR
Registration number
ACTRN12624000914561
Ethics application status
Approved
Date submitted
15/05/2024
Date registered
26/07/2024
Date last updated
26/07/2024
Date data sharing statement initially provided
26/07/2024
Date results provided
26/07/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Use of injectable platelet rich fibrin for the treatment of periapical lesions in teeth
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Scientific title
Effect of injectable platelet rich fibrin (I-PRF) on resolution of periapical lesion within endodontically treated teeth: randomized control trial
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Secondary ID [1]
312159
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none
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
symptomatic apical periodontitis
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Condition category
Condition code
Oral and Gastrointestinal
330480
330480
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
40 teeth from systemically healthy patients with periapical radiolucency and without abscesses were selected, which were randomly divided into two groups of 20 each. Both groups were medicated for two weeks with triple antibiotic paste (TAP) consisting of ciprofloxacin, metronidazole, and minocycline, sealed with Teflon tape and a temporary dressing (Cavit, 3M) in the access cavity. A single endodontist did this procedure.
In control group A, the single cone obturation technique was done alone. In contrast, in trial group B, 4ml of blood was drawn into sterile, non-coated plastic PET tubes and centrifuged at 700 rpm (60 g) for 3 minutes to make I-PRF, which was injected immediately before single cone obturation. The complete procedure took an average of 2 hours. Again the same endodontist did this procedure to completion.
Preoperative radiographs and postoperative radiographs were taken for all the participants at a follow-up of 4 months using the Orstavik Periapical Index (PAI). Two endodontist observers scored the preoperative and postoperative radiographs using PAI for every patient.
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Intervention code [1]
328604
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Treatment: Other
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Comparator / control treatment
Obturation was done alone in control group A without addition of Injectable platelet rich fibrin
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Control group
Active
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Outcomes
Primary outcome [1]
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Periapical healing
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Assessment method [1]
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Orstavik Periapical Index (PAI)
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Timepoint [1]
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Baseline, and 4 months post-intervention.
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Secondary outcome [1]
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Nil
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Assessment method [1]
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Nil
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Timepoint [1]
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Nil
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Eligibility
Key inclusion criteria
• Teeth requiring endodontic treatment with a PAI score of 2 or above in adult patients (above 20)
• Teeth with single root and single canal
• Percussion test positive or negative
• Patients with mature tooth roots
• Patients with necrotic tooth
• Teeth with a diagnosis of irreversible pulpitis
• Pulp test negative or positive
• Patients not taking any antibiotics or analgesics before treatment
• Age between 20 and 60 years at 4 months follow-up
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Minimum age
20
Years
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Maximum age
60
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Perforated teeth with poor prognosis
• Broken down root (Bdr)/ unrestorable teeth/grossly carious teeth
• Patients with immature roots
• Patients with systemic diseases
• Teeth with internal or external root resorption
• Previously endodontically treated teeth
• Patients with draining abscesses or chronic sinus tract
• Teeth with multiple roots or multiple canals
• Patients aged 60 or above
• Patients aged 20 or below
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers
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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)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
21/10/2020
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Date of last participant enrolment
Anticipated
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Actual
22/01/2021
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Date of last data collection
Anticipated
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Actual
20/05/2021
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Sample size
Target
40
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Accrual to date
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Final
40
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Recruitment outside Australia
Country [1]
26309
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Pakistan
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State/province [1]
26309
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Islamabad
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Funding & Sponsors
Funding source category [1]
316524
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Self funded/Unfunded
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Name [1]
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Address [1]
316524
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Country [1]
316524
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Primary sponsor type
University
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Name
riphah international univeristy
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Address
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Country
Pakistan
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Secondary sponsor category [1]
318703
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Hospital
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Name [1]
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Islamic International Dental Hospital
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Address [1]
318703
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Country [1]
318703
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Pakistan
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Riphah International University Ethics Committee
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Ethics committee address [1]
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Islamic international dental hospital, G-7/4, Islamabad, 44000,
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Ethics committee country [1]
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Pakistan
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Date submitted for ethics approval [1]
315317
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01/11/2019
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Approval date [1]
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21/11/2019
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Ethics approval number [1]
315317
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IIDC/IRC/2019/11/005
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Summary
Brief summary
The study aims to compare periapical healing in teeth with symptomatic apical periodontitis undergoing root canal treatment with periapical injection of I-PRF versus root canal treatment alone
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
134318
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Dr Saad Shahnawaz
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Address
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Islamic international dental hospital, St.# 41, 7th Ave, G-7/4, Islamabad, 44000,
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Country
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Pakistan
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Phone
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+923215349841
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Saad Shahnawaz
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Address
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Islamic international dental hospital, St.# 41, 7th Ave, G-7/4, Islamabad, 44000,
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Country
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Pakistan
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Phone
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+923215349841
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Alia ahmed
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Address
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Islamic international dental hospital, St.# 41, 7th AveG-7/4, Islamabad, 44000,
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Country
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Pakistan
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Phone
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+923334372772
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Fax
134320
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Email
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
individual participants Periapical scores
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When will data be available (start and end dates)?
available for 2 years after publication
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Available to whom?
anyone who wishes to access it
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Available for what types of analyses?
only to achieve the aims in the approved proposal
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How or where can data be obtained?
contact principal investigator
[email protected]
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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.
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