None listed
Conditions
Brief summary
The aim of this study is to investigate whether platelet-rich fibrin (PRF), prepared from a patient’s own blood, can improve healing after lower wisdom tooth surgery. The study will compare two types of PRF (H-PRF and A-PRF) to see whether they reduce pain, swelling, difficulty in mouth opening, and dry socket in the first week after surgery. The study will also assess patient satisfaction and gum healing around the neighbouring tooth 3 months after surgery.
Interventions
This study is a randomised controlled trial comparing three different approaches to healing after lower wisdom tooth removal. Eligible individuals who need to have their lower wisdom teeth removed under local anaesthesia at the Faculty of Dentistry, University of Otago will be invited to participate.
Participants will be randomly allocated to one of three groups using a computer-generated random sequence:
1) A group receiving horizontal platelet-rich fibrin (H-PRF)
2) A group receiving advanced
This study is a randomised controlled trial comparing three different approaches to healing after lower wisdom tooth removal. Eligible individuals who need to have their lower wisdom teeth removed under local anaesthesia at the Faculty of Dentistry, University of Otago will be invited to participate. Participants will be randomly allocated to one of three groups using a computer-generated random sequence: 1) A group receiving horizontal platelet-rich fibrin (H-PRF) 2) A group receiving advanced platelet-rich fibrin (A-PRF) 3) A control group receiving routine care, where the socket is left to be filled only with blood clot Random allocation means that group assignment is decided by chance, rather than by the researcher or participant. This helps ensure the groups are similar and allows fair comparison between treatments. Allocation will be concealed until the time of surgery to prevent selection bias. Each participant, regardless of group allocation, will have two tubes of blood samples taken (approximately 10 mL each tube) so that they do not know which group they are in (participant blinding). In the two intervention groups, a PRF clot made from the participant’s own blood will be placed into the tooth socket immediately after extraction. In the control group, no PRF will be placed, and the socket will be left to filled only with blood clot. A-PRF is derived using a fixed-angle centrifuge with the centrifuge protocol of 1300 RPM (~200 RCF) for 8 minutes. H-PRF, representing the new generation of PRF, is derived using a horizontal centrifuge with the centrifuge protocol of 700 RCF for 8 mins. It is claimed that H-PRF has up to four times amount of growth factors, hence exerting enhanced healing properties. (RPM = revolutions per minute; RCF = relative centrifugal force) The surgery will take approximately one hour. All the surgical procedures, regardless of group allocation, will be done by Dr Hermawan Tjoa, a registered dentist with a postgraduate qualification in Oral Surgery who is also an Oral Surgery Registrar occupying a specialty training post at the Faculty of Dentistry, University of Otago. The intervention arms involve the Registrar applying either A-PRF or H-PRF clots directly into the sockets following extraction, hence not relying on patients' adherence.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
16 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
- Patients aged between 16 and 45 years (inclusive) - Healthy patients, classified as American Society of Anesthesiologists (ASA) I or II - Willing to have the extraction of only a single impacted mandibular third molar under local anaesthesia (LA) - Willing to have a venepuncture for the purpose of drawing 20 mL blood to prepare autologous PRF clots and using them in accordance with the research protocol - The involved third molar must require mucoperiosteal flap elevation and ostectomy for removal
Exclusion criteria
- Patients outside the age range of the inclusion criteria - Patients with known systemic medical disorders, such as cardiac, respiratory, endocrine, hepatic, or bleeding disorders, who are classified as ASA III or greater - Patients on anti-platelets and/or anticoagulants one week before, during, or one week after the surgery - Patients on long-term immune-suppressants, or those on these medications for the duration of the study - Patients currently or previously on bone-modifying medications including, but not limited to, bisphosphonates and denosumab - Patients on long-term analgesics, including opioids - Patients having received dental or surgical treatment in the preceding four weeks - Patients with known adverse reactions to paracetamol, non-steroidal anti-inflammatory drugs, codeine, or adrenaline-containing local anaesthetics - Pregnant or lactating women - Patients refusing to undergo the surgery under LA only and/or those unwilling or unable to attend the follow-up appointments - The involved third molar is associated with pathologies, such as odontogenic cysts and tumours, or spreading odontogenic infection, excluding localised infection such as pericoronitis - The degree of impaction of the third molar that mandates surgical removal under intravenous (IV) sedation or general anaesthesia (GA), or mandates coronectomy
Outcome results
None listed