CompletedPhase 4

The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars (A-PRF+: Advanced Platelet Rich Fibrin)

Vietnam76 participantsStarted 2019-10-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Older than 18 of age * Healthy patients (ASA PS index ≤ 2) * The impacted mandibular third molar (IMTM) had to be in the "deep molars" ≥ 2 (according to Montero classification) * Absence of acute inflammation and/or infection in the IMTM areas * No history of NSAID usage four weeks before surgery Exclusion Criteria: * Those with systemic conditions or pharmacologic treatments that alter oral microbiota or immunologic response * Pregnant or breastfeeding women * Those with the presence of any neoplastic lesion (benign or malignant), clinically or radiologically, at the extraction site or close to the IMTM * Those with the presence of any radiolucent lesion larger than 1cm at the IMTM * Those absent of the adjacent teeth * Lack of compliance

What they're measuring

VAS index indicating pain value 2 hours immediately after the lips stopped feeling numb

Timeframe: 2 hours immediately after the lips stopped feeling numb

VAS index indicating pain value 4 hours immediately after the lips stopped feeling numb

Timeframe: 4 hours immediately after the lips stopped feeling numb

VAS index indicating pain value 6 hours immediately after the lips stopped feeling numb

Timeframe: 6 hours immediately after the lips stopped feeling numb

VAS index indicating pain value 1 day after surgery

Timeframe: 1 day after surgery

VAS index indicating pain value 3 days after surgery

Timeframe: 3 days after surgery

VAS index indicating pain value 7 days after surgery

Timeframe: 7 days after surgery

Maximum mouth opening at baseline

Timeframe: Before surgery

Change in maximum mouth opening between baseline and 3 days after surgery

Trial details

NCT IDNCT05824793

SponsorUniversity of Medicine and Pharmacy at Ho Chi Minh City

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04-23

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