title: An appraisal of innovative meloxicam mucoadhesive films for periodontal postsurgical pain control: A double-blinded, randomized clinical trial of effectiveness.
abstract: OBJECTIVE
  Transmucosal analgesic delivery is a promising approach to periodontal postoperative pain management. The purpose of this clinical trial is to appraise the effectiveness of transmucosal drug delivery system with meloxicam films and to identify its minimum effective dosage via this route after periodontal flap surgery.
  
  
  METHODS
  The analgesic mucoadhesive films were formulated using meloxicam and hydroxypropyl methyl cellulose polymer by solvent casting method. The sample size consisted of 60 chronic periodontitis patients who require periodontal flap surgery. The subjects were randomized using lottery method into four groups (Group A - 45 mg; B - 30 mg; C - 20 mg; D - 10 mg meloxicam per film). After periodontal flap surgery, the respective meloxicam mucoadhesive films were placed over the surgical site and were removed on 4(th) day of postsurgery. The primary outcome measure was postsurgical pain level and recorded at 1(st), 2(nd), 3(rd), 4(th), 5(th), 24(th), and 48(th) h using a 0-10 mm visual analog scale with markings from 0 = no pain to 10 = extreme pain.
  
  
  RESULTS
  The postoperative pain control observed in Groups A and B was found to be effective, and the patient comfort level was very satisfactory. Whereas in Group C, it was found to be high in the first 3 h postsurgically, after which adequate pain relief was seen. Group D exhibited inadequate pain relief. No adverse reactions were noted after applying the film in any of the groups.
  
  
  CONCLUSIONS
  Transmucosal delivery of meloxicam was found to be effective and safe in postsurgical pain control of periodontal flap surgery. The minimum effective dosage via this route for meloxicam was found to be with 30 mg mucoadhesive films.
authors: Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India.
authors: S Raja
authors: SR
authors: Rajeswari
authors: Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India.
authors: Triveni M
authors: TM
authors: Gowda
authors: Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India.
authors: Tarun A B
authors: TA
authors: Kumar
authors: Department of Pharmaceutics, Bapuji Pharmacy College, Davangere, Karnataka, India.
authors: J
authors: J
authors: Thimmasetty
authors: Department of Periodontics, Bapuji Dental College and Hospital, Davangere, Karnataka, India.
authors: Dhoom Singh
authors: DS
authors: Mehta
keywords: Meloxicam; minimal effective dose; pain; postoperative; transmucosal route