None listed
Conditions
Brief summary
Many third molars (wisdom teeth) become impacted and fail to erupt, requiring removal due to problems such as decay or gum disease. Surgical removal of third molars is a common oral & maxillofacial procedure that is associated with significant morbidities and risk of complications such as pain, swelling, restricted mouth opening (trismus), dry socket, and post-operative infection. These affect quality of life and prevent patients from returning to their usual daily activities. Interventions that minimise post-operative complications allow patients to recover more comfortably and increase their satisfaction with the surgery. Advanced platelet-rich fibrin (A-PRF) is an improved version of the second-generation plasma concentrate. Recent marketing identifies it as a “wonder drug” which can treat anything from extraction sockets to oro-antral communication, and even promote bone regeneration. Recent studies have demonstrated that A-PRF has potential for improving socket healing following dental extraction. However, the available studies have had limited statistical power and high heterogeneity in outcomes. Since A-PRF is derived from the patient’s own blood, it is a relatively cheap and simple procedure to dress the socket without the risk of cross-infection or foreign body reaction. A-PRF would also be more readily accepted by patients who decline animal-derived products due to their religious/cultural beliefs. This study aims to assess the effects of placing A-PRF in extraction sockets at reducing post-operative pain, facial swelling and the incidence of dry socket following surgical removal of impacted mandibular third molars. An adequately powered randomised control trial such as this will be a valuable addition to current knowledge on A-PRF. Should there be a positive finding, A-PRF could be recommended as standard practice following third molar surgeries to reduce the post-operative burden and increase patient comfort.
Interventions
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
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.
Sponsors
Dr Jesslyn Praganta
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to 40 Years
Healthy volunteers
No
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
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
Outcome results
None listed