Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
Scientific title
Effect of injectable platelet rich fibrin (I-PRF) on resolution of periapical lesion within endodontically treated teeth: randomized control trial
Secondary ID [1] 312159 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
symptomatic apical periodontitis 333812 0
Condition category
Condition code
Oral and Gastrointestinal 330480 330480 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
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.
Intervention code [1] 328604 0
Treatment: Other
Comparator / control treatment
Obturation was done alone in control group A without addition of Injectable platelet rich fibrin
Control group
Active

Outcomes
Primary outcome [1] 338252 0
Periapical healing
Timepoint [1] 338252 0
Baseline, and 4 months post-intervention.
Secondary outcome [1] 435153 0
Nil
Timepoint [1] 435153 0
Nil

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
Minimum age
20 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
numbered containers
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)
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
Actual
21/10/2020
Date of last participant enrolment
Anticipated
Actual
22/01/2021
Date of last data collection
Anticipated
Actual
20/05/2021
Sample size
Target
40
Accrual to date
Final
40
Recruitment outside Australia
Country [1] 26309 0
Pakistan
State/province [1] 26309 0
Islamabad

Funding & Sponsors
Funding source category [1] 316524 0
Self funded/Unfunded
Name [1] 316524 0
Country [1] 316524 0
Primary sponsor type
University
Name
riphah international univeristy
Address
Country
Pakistan
Secondary sponsor category [1] 318703 0
Hospital
Name [1] 318703 0
Islamic International Dental Hospital
Address [1] 318703 0
Country [1] 318703 0
Pakistan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315317 0
Riphah International University Ethics Committee
Ethics committee address [1] 315317 0
Ethics committee country [1] 315317 0
Pakistan
Date submitted for ethics approval [1] 315317 0
01/11/2019
Approval date [1] 315317 0
21/11/2019
Ethics approval number [1] 315317 0
IIDC/IRC/2019/11/005

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

Contacts
Principal investigator
Name 134318 0
Dr Saad Shahnawaz
Address 134318 0
Islamic international dental hospital, St.# 41, 7th Ave, G-7/4, Islamabad, 44000,
Country 134318 0
Pakistan
Phone 134318 0
+923215349841
Fax 134318 0
Email 134318 0
[email protected]
Contact person for public queries
Name 134319 0
Saad Shahnawaz
Address 134319 0
Islamic international dental hospital, St.# 41, 7th Ave, G-7/4, Islamabad, 44000,
Country 134319 0
Pakistan
Phone 134319 0
+923215349841
Fax 134319 0
Email 134319 0
[email protected]
Contact person for scientific queries
Name 134320 0
Alia ahmed
Address 134320 0
Islamic international dental hospital, St.# 41, 7th AveG-7/4, Islamabad, 44000,
Country 134320 0
Pakistan
Phone 134320 0
+923334372772
Fax 134320 0
Email 134320 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• anyone who wishes to access it

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participants Periapical scores

What types of analyses could be done with individual participant data?
• only to achieve the aims in the approved proposal

When can requests for individual participant data be made (start and end dates)?
From:
available for 2 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• contact principal investigator [email protected]

Are there extra considerations when requesting access to individual participant data?
No


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.