The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin)
- Disease/Condition
- PRF
- Drug/Device/Intervention
- A-PRF+
- Study type
- Interventional
- Intervention type
- combination product
- Primary sponsor
- University of Medicine and Pharmacy at Ho Chi Minh City
- Location
- Ho Chi Minh City, Vietnam
- Phase
- Phase 4
- Start date
- Oct 01, 2019
- End date
- Apr 30, 2021
- Enrollment
- 76 participants
VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb,VAS index indicating pain value 4 hours immediately after the lips stopped feeling numb,VAS index indicating pain value 6 hours immediately after the lips stopped feeling numb,VAS index indicating pain value 1 day after surgery,VAS index indicating pain value 3 days after surgery,VAS index indicating pain value 7 days after surgery,Maximum mouth opening at baseline,Change in maximum mouth opening between baseline and 3 days after surgery,Change in maximum mouth opening between baseline and 7 days after surgery,Mean Facial Landmark Length at baseline,Mean Facial Landmark Length 3 days after operation,Mean Facial Landmark Length 7 days after operation
Objectives: This study aims to evaluate the effects of A-PRF+ on postoperative pain,
 swelling, and trismus after surgical removal of impacted mandibular third molars.
 
 Method and Materials: A randomized controlled trial with a parallel design was performed on
 healthy patients with 76 impacted mandibular third molars with similar difficulty level,
 having needs and indications for extraction. All patients had the same standardized
 extraction protocol at the Department of Minor Oral Surgery of the National Hospital of
 Odonto - Stomatology in HCM City. In the study group, patients' blood was collected and
 centrifugated to produce A-PRF+, then placed in the wisdom tooth sockets after surgery. In
 the control group, the tooth sockets were curetted and sutured as in standard protocol. Pain
 value was assessed according to the VAS at 2, 4, and 6-hour time points after patients' lower
 lips stopped feeling numb, and on the 1st, 3rd, and 7th postoperative day; Swelling was
 evaluated based on the measurement between facial landmarks; Trismus was assessed based on
 the distance between incisal edges of upper central incisor and lower incisor during maximum
 mouth opening on the 3rd and 7th postoperative days. Data obtained were statistically
 analyzed.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT05824793
- Type
- Non-Device Trial
Access comprehensive clinical trial information for NCT05824793 through Pure Global AI's free database. This Phase 4 trial is sponsored by University of Medicine and Pharmacy at Ho Chi Minh City and is currently Completed. The study focuses on PRF. Target enrollment is 76 participants.
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