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Trial registered on ANZCTR


Registration number
ACTRN12620000937910
Ethics application status
Approved
Date submitted
23/07/2020
Date registered
21/09/2020
Date last updated
27/01/2022
Date data sharing statement initially provided
21/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of advanced platelet-rich fibrin on post-operative outcomes following wisdom teeth surgery
Scientific title
Does the intra-operative use of advanced platelet-rich fibrin (A-PRF) improve post-operative outcomes in third molar surgery?
Secondary ID [1] 301368 0
None
Universal Trial Number (UTN)
U1111-1252-5079
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative complications following impacted mandibular wisdom teeth surgeries 317612 0
Condition category
Condition code
Oral and Gastrointestinal 315689 315689 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 316684 316684 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placement of platelet-rich fibrin + Surgispon (aerated gelatin sponge dressing) into dental sockets following surgical removal of impacted wisdom teeth
1. To prepare the platelet-rich fibrin, 10-20ml of blood is drawn via the patient's IV cannula (which is inserted for IV sedation patients) into plastic tubes. These tubes are then spun in the centrifuge according manufacturer's instruction to separate the blood cells and plasma, and to allow the fibrin strands to clot together with the platelet cells and form platelet-rich fibrin.
2. As each individual has a different percentage of platelets, white blood cells and plasma, the amount of platelet-rich fibrin provided to each participant will be whatever is retrieved from the 10-20ml's worth of blood sample once the cell layers have been separated via the centrifugation
3. Each participant will receive both intervention and control treatments (one on each side of the mouth) in the same surgical procedure within one IV sedation session.
4. We will allocate 90 minutes (sedation + surgery time) for each participant.
5. The surgical team performing the intervention will consist of the dentist (Oral Surgery Post Graduate student), a dental assistant, and a registered nurse.
6. Medical health questionnaire will be recorded on the patient's file, along with the operation note which will detail the pre-op assessment of surgical difficulty of each tooth, pre-op condition of the teeth (to ensure there's no active infection present), surgical time taken for each tooth, and amount + type of sutures placed. The participants will have their questionnaires and pain diary checked by the dentist performing the intervention to ensure that they're completed correctly.
Participants will be asked to record their pain level (1-10) and any pain medications taken on the pain diary twice a day (morning & night) for the first 2 days following surgery, and then once a day from post-operative day 3-7.
Intervention code [1] 317702 0
Treatment: Other
Comparator / control treatment
placement of Surgispon aerated gelatin sponge dressing into dental socket following surgical removal of impacted wisdom teeth
Control group
Active

Outcomes
Primary outcome [1] 324536 0
facial swelling will be assessed by scanning the face using 3-dimensional volumetric morphometric imaging software (3dMDtrio system).
Timepoint [1] 324536 0
post-operative day 2 (primary timepoint) and day 7
Primary outcome [2] 324537 0
post-operative pain will be analysed using 100mm visual analogue scale.
Timepoint [2] 324537 0
Post-operative pain will be measure daily from post-operative day 1-7, with assessment on day 2 being primary timepoint.
Secondary outcome [1] 384933 0
Incidence of dry socket.
The original dental surgeon who did the surgery will also be the one doing the review. Dry socket will be diagnosed if there is severe postoperative pain surrounding the alveolus after post-operative day 2 (pain greater than 70/100 on a 100mm visual analogue scale) that does not improve with analgesics onboard, followed by partial or total clot loss in the interior of the alveolus, with or without halitosis.
If there are signs of acute infection of the socket, e.g. pus/suppuration, then the socket will be diagnosed as infected instead of dry socket.
Timepoint [1] 384933 0
anytime in the 7 days following surgery

Eligibility
Key inclusion criteria
- 16-40 years of age (inclusive)
- Healthy patients (ASA I or ASA II)
- Requires removal of bilateral symmetrically impacted mandibular third molars
- Consents to having IVS and LA for the third molar surgery
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with known systemic disorders such as cardiac, hepatic, endocrine, renal or
bleeding disorders that are deemed to be classified as ASA III and ASA IV
- Patients on anticoagulant / antiplatelet therapy
- Patients who received dental treatment or surgery in the past 4 weeks
- Patients who are allergic to or cannot tolerate paracetamol, non-steroidal anti-
inflammatory drugs, codeine, corticosteroids, or adrenaline-containing lignocaine
- Pregnant or lactating patients
- Pre-existing local infection with associated swelling around third molars
- Patients refusing to undergo IVS&LA, be involved in the study and/or unable to attend
follow-up appointments

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generator will be used to allocate a number to the participant.
Odd-numbered participants will get the intervention placed in their left tooth socket and even-numbered participants will get the intervention placed in their right tooth socket.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Other
Other design features
Split-mouth design
Each patient act as their own control. One side of the mouth is the intervention side while the other side of the mouth is the control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size determination: To detect a moderate effect size of 0.45s on facial swelling between the intervention and control sides, with a two-sided 5% significance level and power of 90%, a sample size of 52 was necessary. The target total sample size will be set at 70 to account for drop-out from loss of data such as incomplete pain diary records and failure to attend follow up appointments as prescribed in the study protocol. This sample size also suffices to detect an effect size of 0.45s in pain outcome as well, with the same power and significance level. https://www.stat.ubc.ca/~rollin/stats/ssize/n1.html was used for calculation of sample size.

STATISTICAL ANALYSIS
Statistical analyses will be undertaken using Stata version 15 (StataCorp LP, Texas, USA). Following the computation of summary statistics for the dependent variables and covariates, participant characteristics will be tabulated and analysed using a multivariable linear regression model. Baseline characteristics and categorical data will be compared using chi-squared tests. Multivariate modelling for the main dependent variables (facial swelling and postoperative pain) will accommodate the clustering inherent in the split-mouth design, along with a term representing the side of the mouth on which the intervention has been placed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
6/10/2020
Actual
1/12/2020
Date of last participant enrolment
Anticipated
Actual
1/07/2021
Date of last data collection
Anticipated
Actual
25/07/2021
Sample size
Target
70
Accrual to date
Final
70
Recruitment outside Australia
Country [1] 22791 0
New Zealand
State/province [1] 22791 0
Otago

Funding & Sponsors
Funding source category [1] 305809 0
Charities/Societies/Foundations
Name [1] 305809 0
New Zealand Dental Association Research Foundation
Country [1] 305809 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jesslyn Praganta
Address
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country
New Zealand
Secondary sponsor category [1] 306251 0
None
Name [1] 306251 0
Address [1] 306251 0
Country [1] 306251 0
Other collaborator category [1] 281407 0
Individual
Name [1] 281407 0
Dr Harsha De Silva
Address [1] 281407 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country [1] 281407 0
New Zealand
Other collaborator category [2] 281408 0
Individual
Name [2] 281408 0
A/Prof Rohana De Silva
Address [2] 281408 0
Department of Oral Diagnostic and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country [2] 281408 0
New Zealand
Other collaborator category [3] 281409 0
Individual
Name [3] 281409 0
Prof Murray Thomson
Address [3] 281409 0
Department of Oral Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country [3] 281409 0
New Zealand
Other collaborator category [4] 281410 0
Individual
Name [4] 281410 0
Prof Darryl Tong
Address [4] 281410 0
Department of Oral Diagnostics and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country [4] 281410 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306079 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 306079 0
Ethics committee country [1] 306079 0
New Zealand
Date submitted for ethics approval [1] 306079 0
31/07/2020
Approval date [1] 306079 0
30/09/2020
Ethics approval number [1] 306079 0
20/STH/129

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

Contacts
Principal investigator
Name 102626 0
Dr Jesslyn Praganta
Address 102626 0
Department of Oral Diagnostics and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 102626 0
New Zealand
Phone 102626 0
+64 2102309366
Fax 102626 0
Email 102626 0
jesslyn.praganta@otago.ac.nz
Contact person for public queries
Name 102627 0
Jesslyn Praganta
Address 102627 0
Department of Oral Diagnostics and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 102627 0
New Zealand
Phone 102627 0
+64 2102309366
Fax 102627 0
Email 102627 0
jesslyn.praganta@otago.ac.nz
Contact person for scientific queries
Name 102628 0
Jesslyn Praganta
Address 102628 0
Department of Oral Diagnostics and Surgical Sciences
Faculty of Dentistry
University of Otago
PO Box 56
Dunedin 9054
Country 102628 0
New Zealand
Phone 102628 0
+64 2102309366
Fax 102628 0
Email 102628 0
jesslyn.praganta@otago.ac.nz

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


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.