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Completed

NCT Number: NCT05824793

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

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.

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Key information

Conditions

PRF Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Trismus

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Hospital of Odonto-Stomatology, Ho Chi Minh City

Ho Chi Minh City, Ho Chi Minh, 70000, Vietnam

About this study

The study was a parallel randomized controlled trial on patients having impacted mandibular third molar (IMTM) extraction. This study was performed at the Department of Minor Oral Surgery in the National Hospital of Odonto - Stomatology in HCM City from October 2019 to April 2021. All patients who had IMTM extraction were examined by the dentists at the Department of Minor Oral Surgery. If IMTM were Montero≥2(7), patients would be referred to the research team. After reviewing the criteria for inclusion and exclusion, the investigators explained to all patients the information about the operation, healing time, and possible complications, and the investigators obtained their informed consent before surgery.

Based on recent research with a power of 80% and α=5%, the investigators calculated the minimum sample size for comparing 2 mean values. The result is each group needs a minimum of 36 participants. The initial sample consisted of 85 in both groups intended to participate in this study at the Department of Minor Oral Surgery in the National Hospital of Odonto - Stomatology in HCM City from October 2019 to April 2021. One patient was excluded from this study because of the ASA PS Index>2. After randomization, one patient in the study group could not collect blood for centrifugation; seven patients were excluded due to lack of compliance (four in the control group, three in the study group). Finally, 76 samples remained in this study (Male 23, Female 53).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A-PRF+

Combination Product

A-PRF+ contributes to accelerating the healing process, more rapid revascularization, and reducing the risk of inflammation at the graft site. It leads to a decrease in the severity of postoperative complications. Many authors have mentioned platelet concentrates as an effective adjunction that improves the healing of hard and soft tissue and decreases pain, swelling, and trismus. However, there are still some controversial results in the literature. Recently, it has been demonstrated that the production of PRF with lower centrifugal force and lower centrifugal time has more potential to release several growth factors and facilitate more favorable healing at the site of the application when compared to standard PRF. Promoting the healing process after tooth extraction using A-PRF+ aims to manage patient discomfort as well as postoperation complications.

Primary outcomes

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

    Time frame: 2 hours immediately after the lips stopped feeling numb

    The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.

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

    Time frame: 4 hours immediately after the lips stopped feeling numb

    The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.

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

    Time frame: 6 hours immediately after the lips stopped feeling numb

    The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.

  4. VAS index indicating pain value 1 day after surgery

    Time frame: 1 day after surgery

    The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.

  5. VAS index indicating pain value 3 days after surgery

    Time frame: 3 days after surgery

    The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.

  6. VAS index indicating pain value 7 days after surgery

    Time frame: 7 days after surgery

    The pain was evaluated subjectively by suggesting patients mark the severity of pain on the VAS, which ranges from 0 (no pain) to 10 (unbearable pain) in increasing order of pain severity. The patients would record their pain score by marking a point on a straight line; the pain point would be the measured distance from the left end to the point that the patient marked.

  7. Maximum mouth opening at baseline

    Time frame: Before surgery

    The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus.

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

    Time frame: 3 days after surgery

    The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus

  9. Change in maximum mouth opening between baseline and 7 days after surgery

    Time frame: 7 days after surgery

    The maximum mouth opening (the distance between incisal edges of upper and lower central incisors) difference before and after surgery indicates trismus

  10. Mean Facial Landmark Length at baseline

    Time frame: Before surgery

    Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.

  11. Mean Facial Landmark Length 3 days after operation

    Time frame: 3 days after operation

    Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.

  12. Mean Facial Landmark Length 7 days after operation

    Time frame: 7 days after operation

    Preoperatively, patients are marked with landmarks on the face A, B, C, D with an indelible brush to measure facial swelling. A is the canthus of the eye, B is the gonion, C is the tragus, D is the mouth commissure. Patients were seated in a relaxing position with the inferior border of the mandible parallel to the floor. Use a non-elastic ruler that measures preoperative measurements, including AB as vertical swelling score and CD as horizontal swelling score. The patient was re-measured the length size of the two AB and CD that had been marked and measured.

Sponsors and collaborators

Lead sponsor

University of Medicine and Pharmacy at Ho Chi Minh City

Other

Registry information

Official study title

The Efficacy of A-PRF+ on Postoperative Outcomes Following Surgical Removal of Impacted Mandibular Third Molars: a Randomized Controlled Trial

Acronym: A-PRF+

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 24, 2023
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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