Hyaluronic Acid and Amino Acid Gel Applied to the Alveolar Socket After Mandibular Third Molar Extraction
Condition: Pain; Oral Surgery; Third Molar Extraction
Study type: Interventional

Summary: 
      Objective: The study aimed to assess the effect of topical application of an amino acid +
      sodium hyaluronate acid gel after lower third molar extraction.

      Study design: 136 patients requiring lower third molar extraction were enrolled. An amino
      acid + sodium hyaluronate acid (HA) gel was applied to the sockets of the patients in the
      treatment group immediately following extraction; the sockets of the controls were simply
      flushed with a sterile saline solution. 7 and 14 days after surgery, patients' outcomes and
      postoperative complications were evaluated. Cumulative incidence of dehiscence and secondary
      outcome measures were analyzed using a chi-square test.
    

Detailed description: 
      A lower third molar was extracted under local anesthesia generally involving an inferior
      alveolar nerve block associated with a buccal nerve block (2% mepivacaine with 1:100,000
      epinephrine, Optocain, Molteni Dental, Italy), plus sedation as necessary. All the surgical
      tools and materials as well as the surgical field were sterile. A full-thickness flap was
      raised and, if necessary, osteotomy and tooth sectioning were performed using a straight
      handpiece with dedicated burs under copious irrigation with sterile saline solution. The
      extraction was completed with curved and straight extractors, the socket was closely
      inspected and the dental follicle was removed. The bone edges were refined to remove the bone
      spurs with a bone lime and then irrigated with abundant sterile 0.9% saline solution.
      Depending on the group to which the patient was assigned, one of the following procedures was
      carried out: the socket was filled with a topical amino acid + sodium hyaluronate gel
      (Aminogam®, sterile syringe 2 ml) or the socket was flushed, using a 2ml sterile syringe
      similar to one utilized to apply the gel, with sterile physiological solution. The flap was
      then repositioned and sutured (Novosyn 4.0, B. Braun AG, Melsungen, Germany) to allow healing
      by primary intention. After surgery, the patients were prescribed antibiotics (amoxicillin
      clavulanate 1 g every 12 hours for 6 days, or clarithromycin 250 mg every 12 hours for 6
      days) and painkillers (paracetamol 1000 mg every 8 hours was recommended). The patients were
      also provided standard postoperative recommendations regarding activity, diet, and smoking.
      The following data were registered at the time of surgery: the range of pre-operative mouth
      opening measurement (assessed by measuring the distance between the incisors), the type of
      sedation utilized, if osteotomy or root resection was carried out, the quantity of
      peri-operative bleeding, the amount of time between incision and suture (surgical procedure
      time).
    

Intervention name(s): Aminogam
Intervention type(s): Device
Intervention description(s): A lower third molar was extracted. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. Depending on the group to which the patient was assigned, one of the following procedures was carried out.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: third molar extraction; hyaluronic acid