None listed
Conditions
Brief summary
Scientific question: 1) Are there any differences in procedural efficacy and post-operative outcomes between conventional 3-0 vicryl rapide suture wound closure and 3-0 V-loc knotless suture wound closure in third molar surgery? Hypothesis: 1) Knotless wound closure would be more efficacious than conventional simple interrupted wound closure in third molar surgery. 2) Knotless sutures would accumulate less debris and plaque, reducing erythema and eliminating irritation from the presence of knots, leading to an improvement in quality of life Statistical question: 1) What is the relative efficacy of knotless sutures in relation to third molar surgical wound closure and post-operative pain, swelling and irritation?
Interventions
The planned intervention uses COVIDIEN 3-0 V-Loc (VLOCM1824) knotless sutures for wound closure following surgical third molar removal. The intervention will be administered by the principal investigator, a dental council registered practitioner.
The overall duration of the procedure is between 60-90 minutes, 20-30 minutes for the removal of each third molar as well as the closure of the site using the 1) knotless suture in the intervention site/side and 2) closure using the control material (c
The planned intervention uses COVIDIEN 3-0 V-Loc (VLOCM1824) knotless sutures for wound closure following surgical third molar removal. The intervention will be administered by the principal investigator, a dental council registered practitioner. The overall duration of the procedure is between 60-90 minutes, 20-30 minutes for the removal of each third molar as well as the closure of the site using the 1) knotless suture in the intervention site/side and 2) closure using the control material (current institutional standard, 3-0 vicryl rapide). The suture material is absorbable and do not commonly require removal.
Sponsors
Nigel Tan
Study design
Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion criteria
1. Patients referred for third molar removal from a primary care provider 2. Patients who volunteer participation 3. Patients may be either male or female 4. The patient has been screened by the primary investigator or supervising specialist for suitability to participate in the study 5. Are aged between 18 and 44 years 6. Are able to understand verbal and written instructions. 7. Present with bilateral similarly impacted mandibular third molars as determined using Winter’s (1926) classification system , requiring surgical removal 8. Are able to tolerate outpatient oral surgery under local anaesthetic and intravenous sedation 9. ASA l or ll 10. The patient has provided informed consent regarding: a. Participation in the study i. The use of knotless sutures in the closure of the surgical wound b. Surgical removal of third molars under local anaesthetic and intravenous sedation
Exclusion criteria
1. American society of anaesthesiologists (ASA) physical classification III or IV 2. Polypharmacy (greater than or equal to 5) medications 4. Patients contraindicated to undergo surgical third molar removal 5. Patients contraindicated to treatment under monoagent midazolam IV sedation 6. Opioid and illict drug addiction 7. Patients that have allergies or contraindications to the procedural usage of: a. midazolam b. dexamethasone c. parecoxib d. paracetamol e. ibuprofen f. co-amoxiclav g. cefazolin h. clindamycin i. chlorhexidine 8. The presence of symptomatic pericoronitis. 9. The presence of other pathology in the oral cavity. 10. Patients with poor oral hygiene (plaque >1/3 of tooth surface). 11. Pregnant or lactating women. 12. Male patients who do not agree to facial hair removal. 13. Patients who are unable to give informed consent. 14. Patients who decline participation. 15. Patients who are unable to attend the required follow-up appointments. 16. Patients who are unable to comprehend directions and instructions. 17. Patients unwilling to trim facial hair for the purposes for the measurement of facial swelling
Outcome results
None listed