An appraisal of innovative meloxicam mucoadhesive films for periodontal postsurgical pain control: A double-blinded, randomized clinical trial of effectiveness

Abstract

Background and 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.Materials and 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 4th day of postsurgery. The primary outcome measure was postsurgical pain level and recorded at 1st, 2nd, 3rd, 4th, 5th, 24th, and 48th 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.Conclusion: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.

Evaluation of a curcumin-containing mucoadhesive film for periodontal postsurgical pain control

“…These time intervals were selected based on the results of a study by Rajeswari et al ,[35] who evaluated periodontal postoperative pain control using meloxicam mucoadhesive films.…”

“…Based on a study by Rajeswari et al ,[35] the power of the study was 80% and the required sample size was calculated as 13, which was rounded off to 15 patients with bilateral moderate or advanced periodontitis.…”

Topic delivery of analgesics in oral surgery

“…They performed a clinical trial on 68 patients and demonstrated a pain relief. Then, Al Hezaimi et al and Movassaghian et al published in 2010 and 2011, respectively, clinical trials showing pain relief using ketorolac and amitriptyline respectively compared to a placebo [6,17]. Throughout their investigations, these authors demonstrated that the formulation of their tablets, in term of molecular weight of the polymers and HPMC/CMC ratio, plays a crucial role.…”

“…However, on a clinical point of view, only a few of them have been evaluated. The main part of polymer used is composed of cellulose and its derivatives (cellulose, methylcellulose, carboxymethyl cellulose (CMC) and hydroxylpropyl methylcellulose HPMC)), which are formulated alone or with a copolymer [6,7,[13][14][15][16][17]. The formulations aim at optimizing the encapsulation of the analgesic while controlling its leakage.…”

“…Even if this delivery route is very convenient (easy administration, low costs) and effective, it suffers from several drawbacks linked to the administration route, to the molecule used or to the patient's compliance (Tab. 1) [6,7].…”