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

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 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. 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.

[1]  C. Cellini,et al.  Postoperative Pain Control , 2013, Clinics in Colon and Rectal Surgery.

[2]  T. Keefe,et al.  Bioequivalence in dogs of a meloxicam formulation administered as a transmucosal oral mist with an orally administered pioneer suspension product. , 2013, Journal of veterinary pharmacology and therapeutics.

[3]  Marc B. Brown,et al.  Advances in oral transmucosal drug delivery. , 2011, Journal of controlled release : official journal of the Controlled Release Society.

[4]  Hom-lay Wang,et al.  Evaluation of novel adhesive film containing ketorolac for post-surgery pain control: a safety and efficacy study. , 2011, Journal of periodontology.

[5]  R. Moore,et al.  Single dose oral meloxicam for acute postoperative pain in adults. , 2009, The Cochrane database of systematic reviews.

[6]  C. Melia,et al.  The extended release properties of HPMC matrices in the presence of dietary sugars. , 2009, Journal of controlled release : official journal of the Controlled Release Society.

[7]  A. Domb,et al.  Mucoadhesive polymers for delivery of drugs to the oral cavity. , 2008, Recent patents on drug delivery & formulation.

[8]  R. Seymour,et al.  An evidence-based update of the use of analgesics in dentistry. , 2008, Periodontology 2000.

[9]  P. Moore,et al.  Adverse drug interactions in dentistry. , 2008, Periodontology 2000.

[10]  H. Toker,et al.  Effect of meloxicam on gingival crevicular fluid IL-1beta and IL1 receptor antagonist levels in subjects with chronic periodontitis, and its effects on clinical parameters , 2006, Clinical Oral Investigations.

[11]  N. Buduneli,et al.  In vitro studies of a degradable device for controlled-release of meloxicam. , 2005, Journal of clinical periodontology.

[12]  B. Mealey,et al.  Post-surgical infections: prevalence associated with various periodontal surgical procedures. , 2005, Journal of periodontology.

[13]  A. Dehpour,et al.  Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. , 2003, Journal of endodontics.

[14]  D. Türck,et al.  Meloxicam oral suspension: a treatment alternative to solid meloxicam formulations , 2001, Inflammation Research.

[15]  P. Schoenfeld.  Gastrointestinal safety profile of meloxicam: a meta-analysis and systematic review of randomized controlled trials. , 1999, The American journal of medicine.

[16]  N. Davies,et al.  Clinical Pharmacokinetics of Meloxicam , 1999, Clinical pharmacokinetics.

[17]  V. Trach,et al.  Local tissue tolerability of meloxicam, a new NSAID: indications for parenteral, dermal and mucosal administration. , 1996, British journal of rheumatology.

[18]  B. Auvinet,et al.  Comparison of the onset and intensity of action of intramuscular meloxicam and oral meloxicam in patients with acute sciatica. , 1995, Clinical therapeutics.

[19]  R. Hutchinson,et al.  The incidence and severity of complications and pain following periodontal surgery. , 1985, Journal of periodontology.

[20]  R. Seymour.  Efficacy of paracetamol in reducing post-operative pain after periodontal surgery. , 1983, Journal of clinical periodontology.

[21]  S. Tran,et al.  Managing postoperative pain following periodontal surgery. , 2013, Journal.

[22]  R. Narayan,et al.  Formulation and evaluation of buccal film of Ivabradine hydrochloride for the treatment of stable angina pectoris , 2013, International journal of pharmaceutical investigation.

[23]  T. Sorsa,et al.  Gingival crevicular fluid matrix metalloproteinase-8 levels following adjunctive use of meloxicam and initial phase of periodontal therapy. , 2002, Journal of periodontology.

[24]  F. Degner,et al.  The efficacy and tolerability of an 8-day administration of intravenous and oral meloxicam: a comparison with intramuscular and oral diclofenac in patients with acute lumbago. German Meloxicam Ampoule Study Group. , 1996, Current medical research and opinion.

[25]  M. Rathbone,et al.  The oral cavity as a site for systemic drug delivery , 1994 .

[26]  S. Bergman,et al.  Nonsteroidal anti-inflammatory agents in relieving dental pain: a review. , 1983, Journal of the American Dental Association.