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ORIGINAL RESEARCH Table of Contents   
Year : 2010  |  Volume : 21  |  Issue : 3  |  Page : 408-412
Efficacy and acceptability of 0.074% diclofenac-containing mouthwash after periodontal surgery: A clinical study


1 Department of Periodontics, Institute of Dental Sciences, Bareilly, India
2 Department of Periodontics, M G Dental College & Hospital, Jaipur, India
3 Department of Periodontics, KLES Institute of Dental Sciences, Belgaum, India
4 Department of Periodontics, YMT Dental College, Navi Mumbai, Mumbai, India

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Date of Submission21-May-2009
Date of Decision12-Sep-2009
Date of Acceptance21-May-2010
Date of Web Publication29-Sep-2010
 

   Abstract 

Background: The systemic use of non-steroidal anti-inflammatory drugs are associated with various side-effects like hepatotoxicity, blood dyscrasias, nephrotoxicity and gastric irritability. Among these, gastric irritability is the most common and the most important one, which should be taken care of. Therefore, it may be preferable to use a local formulation such as a mouthwash to treat the inflammatory conditions of the oral cavity.
Aim: To determine the efficacy and acceptability of 0.074% diclofenac mouthwash in relieving pain and inflammation of post-periodontal surgery patients.
Materials and Methods: The study was designed as a double-blind, placebo-controlled clinical trial. Twenty chronic periodontitis patients who were scheduled for full-mouth periodontal flap surgery were randomized to receive either diclofenac mouthwash or placebo to rinse with 15 ml of solution daily for a period of 7 days. Modified gingival index (Lobene 1986) was used to verify gingival inflammation and visual analog scale was used to assess pain. After the baseline measurements for all the parameters were recorded, spontaneous pain and burning were evaluated daily while redness and edema were recorded on the 3 rd and 7 th day from the day of treatment.
Results: Data obtained were analyzed statistically using paired " t" test for intragroup comparison and unpaired " t"-test for intergroup comparison. Spontaneous pain was significantly reduced by diclofenac mouthwash. Other parameters, i.e. gingival inflammation and swelling, had not shown significant reduction in scores in either group, although the reduction was higher in the test group.
Conclusion: The new 0.074% diclofenac mouthwash is an effective and tolerable medicinal product for post-surgical symptomatic relief.

Keywords: Diclofenac mouthwash, pain, visual analog scale, periodontal surgery

How to cite this article:
Agarwal S, Mathur S, Kothiwale S, Benjamin A. Efficacy and acceptability of 0.074% diclofenac-containing mouthwash after periodontal surgery: A clinical study. Indian J Dent Res 2010;21:408-12

How to cite this URL:
Agarwal S, Mathur S, Kothiwale S, Benjamin A. Efficacy and acceptability of 0.074% diclofenac-containing mouthwash after periodontal surgery: A clinical study. Indian J Dent Res [serial online] 2010 [cited 2014 Jul 30];21:408-12. Available from: http://www.ijdr.in/text.asp?2010/21/3/408/70814
Managing acute post-operative pain is inherent to dental practice. The etiology of post-operative pain is the progress of inflammation and swelling in the area of the procedure. The magnitude of this depends on the degree of tissue damage produced and on the extent of operative trauma. [1] Tissue damage resulting from surgery induces the production of Cyclooxygenase-2 (COX-2), which in turn leads to the synthesis of prostaglandins (PGs), which sensitize pain fibers and promote inflammation. [2]

Non-steroidal anti-inflammatory drugs (NSAIDs) are among the most widely used class of drugs for the management of acute and chronic pain in dentistry. Pain activates the pituitary-adrenal axis with subsequent pituitary secretion of β-endorphin, leading to elevated levels of circulating β-endorphins. NSAIDs affect the release of β-endorphin during post-operative pain.[3] Clinical trials have shown that NSAIDs are effective in the management of any level of dental pain, whether mild, moderate or severe. [3],[4] The post-operative sequel of dental procedures also includes other signs of inflammation due to tissue injury, most prominently edema. NSAIDs also minimize edema following surgical procedures.

NSAIDs are associated with many adverse effects, like gastric irritability, which lead to a number of contraindications. Inhibition of PG synthesis diminishes the protective effect of PG on the gastric mucosa. This inhibition may lead to dyspepsia and, more seriously, to gastric bleeding. Enteric-coated formulations may reduce the likelihood of dyspepsia but they do not prevent gastric damage and the subsequent bleeding. [2] Thus, recent line of NSAID research has focused on the development of daily topical administration forms such as gels, toothpastes and rinses, as many of the compounds like flurbiprofen are readily absorbed through the gingival tissues. In general, NSAIDs are lipophilic and easily penetrate into the oral and gingival tissues to rapidly inhibit local gingival crevicular fluid PGE 2 levels within 1 h. [5],[6]

Topical NSAIDs like 0.3 mg flurbiprofen gel have shown benefit in the treatment of periodontitis. [6] Data on the efficacy of a topical ketorolac rinse have also been presented by Jeffcoat et al. [7] According to them, rinsing twice daily with 0.1% ketorolac tromethamine significantly reduces alveolar bone loss and gingival crevicular fluid PGE 2 levels.

Diclofenac is a powerful anti-inflammatory and analgesic drug that is well suited for local use in the oral cavity. Diclofenac competes with arachidonic acid in a dose-dependent manner for binding with platelet COX. This results in decreased production of PG and thus reduces inflammation, swelling and pain. The drug also affects polymorphonuclear leukocyte function in vitro, thereby reducing chemotaxis, superoxide toxic radical production and neutral protease production and, thereby, reducing inflammation. [8],[9]

Thus, an attempt has been made in this study to determine the local anti-inflammatory and analgesic effect of 0.074% diclofenac mouthwash on post-periodontal surgery patients.


   Materials and Methods Top


The study was carried out and approved by the local research and ethical committee, KLES Institute of Dental Sciences, Belgaum. Out-patients reporting to the Department of Periodontics were the source of data. Informed consent was obtained from all study subjects.

Twenty chronic periodontitis patients (eleven males and nine females) scheduled for full quadrant flap surgery were enrolled for the study. Subjects in the age range of 35-45 years and having a minimum of 16 teeth with three posterior teeth in each quadrant were included. Patients with acute periodontal disease, systemic disease/condition that affects oral tissues, history of intolerance or hypersensitivity to active substance diclofenac and pregnant/lactating women were excluded from the study. Also, patients who had taken systemic NSAID therapy during the last 3 months of the study were excluded.

The study was designed as a randomized, double blind, placebo-controlled clinical trial. In all subjects, a similar flap technique, i.e. modified flap operation by Kirkland, [10] was performed, with crevicular incision. Direct loop sutures were placed to approximate the flap edges. Periodontal pack was not given as it might have interfered with the penetration of the drug into the gingival tissues and was also not required for well-approximated wound edges. Subjects were randomized to receive either diclofenac mouthwash or placebo to rinse with 15 ml solution twice daily for 7 days after surgery. The 10-point visual analog scale (VAS) was used to assess pain and the Modified Gingival Index (MGI) [11] was used to assess the inflammation. Additional parameters like swelling and burning sensation was evaluated on a 5-point scale (0=absent, 1=mild, 2=moderate, 3=intense, 4=not evaluated). Acceptability of the product was evaluated on a 4-point scale (0=unacceptable, 1=unpleasant, 2=acceptable, 3=pleasant).

A baseline measurement of all parameters was performed at 8 PM on the day of the surgery once the effect of anesthesia wears off. Spontaneous pain and burning were evaluated daily at 8AM for 7 days while redness and edema were evaluated after 3 and 7 days of treatment.

Data pertaining to the VAS score and swelling scores were analyzed using Wilcoxon Sign Rank test for intragroup comparison and Mann-Whitney U-test for intergroup comparison. Data obtained for the MGI score was subjected to statistical analysis using Student's paired "t"-test for intragroup comparison and Student's unpaired "t"-test for intergroup comparison. The level of significance was taken as 0.05 (P<0.05).


   Results Top


All subjects completed the study. Compared to baseline measurements, spontaneous pain was significantly reduced by diclofenac mouthwash on the first day of treatment(P=0.0020) [Table 1]. After a week of treatment, the pain intensity was reduced to zero in 90% of the cases. While in the placebo group, no improvement or slight worsening of the score was reported on the first day of treatment versus baseline (P=1.0000) [Table 2]. Comparing both the groups, reduction in pain score is significantly higher in the test group than in the control group (P<0.0001) [Table 3], [Figure 1].
Table 1 :Visual analog scale score for the test group


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Table 2 :Visual analog scale score for the control group


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Table 3 :Comparison of visual analog scale scores between the test and control groups


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Figure 1 :Graphical representation of visual analog scale scores for cases and controls

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Other parameters, i.e. gingival inflammation, showed a highly significant reduction in the scores in the test group when compared to baseline (P<0.0001) [Table 4] and significant reduction in the control group when compared to baseline (P=0.0003) [Table 5]. However, when comparing both the groups, the difference was not statistically significant at any time interval (P>0.05) [Table 6],[Figure 2]. Reduction in swelling on the 3 rd day was significant in the test group (P=0.0312) [Table 7] but was not significant in the control group (P=0.1250) [Table 8]. Reduction in swelling with diclofenac is not significant when compared to placebo (P>0.05) [Table 9],[Figure 3]. Mild burning was reported in few subjects rinsing with diclofenac mouthwash but none of the placebo group patients reported the same. Palatability was judged as pleasant/acceptable in all cases.
Table 4 :Modified gingival index score for the test group


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Table 5 :Modified gingival index score for the control group


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Table 6 :Comparison of modified gingival index scores between the case and control groups


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Table 7 :Swelling scores in the test group


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Table 8 :Swelling scores in the control group


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Table 9 :Comparison of swelling scores between the test and control groups


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Figure 2 :Graphical representations of modified gingival index scores for cases and controls.

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Figure 3 :Graphical representations of the swelling scores for cases and controls

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   Discussion Top


The present study has clearly shown that 0.074% diclofenac mouthwash at a dose of 15 ml twice daily is endowed with significant local analgesic effects (P<0.0001) [Table 1] and [Table 3]. The anti-inflammatory effect was also found to be favorable for the diclofenac group, although this was not significant.

Diclofenac is sparingly soluble in water and hence its release is favored from aqueous solutions. [12] The new 0.074% diclofenac mouthwash has overcome the disadvantages of insolubility and unpleasant taste in an oral liquid formulation.

As most NSAIDs are lipophilic, diclofenac too appeared to be absorbed rather quickly when considering the brief contact of the solution with the oral mucosa, i.e. 1 min. The proposed dose regimen of 1 min rinsing with 15 ml solution twice daily for 1 week was found to be optimum. The tolerability of the product has been confirmed to be good, with no adverse effects, except mild burning in few subjects.

Results of the present study are in corroboration with one multicentric clinical study. In this study, the efficacy of 0.074% diclofenac mouthwash was evaluated in 79 patients with pain intensity at the end of anesthesia effect, equivalent to 54.8±15.1 of VAS. All parameters, i.e. spontaneous pain, redness and edema, showed significant improvement. The physician's and patient's final judgement recorded resolution/improvement in 94.1% of the cases, concluding that the mouthwash is efficacious and tolerable in the treatment of inflammatory condition of the buccal cavity following oral/periodontal surgery. [13]

Another double-blind, placebo-controlled clinical study confirmed the efficacy, acceptability and safety of a mouthwash containing 0.074% diclofenac in patients undergoing oral or periodontal surgery. The pain score was significantly lower in the diclofenac group than in the placebo group, both at 8 PM on the day of surgery(P=0.003) and at 8 AM the following day (P=0.001). Also, the gingival inflammatory condition were significantly improved by diclofenac mouthwash versus placebo(P<0.001). Both test and placebo formulations were found to be safe and palatable. [14]

In another study, Kostrica et al. [15] evaluated the efficacy of 0.074% w/v diclofenac mouthwash in treating mucositis of the oral cavity by radiotherapy. Seventy-seven subjects were asked to rinse thrice daily with 15 ml of solution for a minimum of 2 weeks up to a maximum of 6 weeks. This placebo-controlled trial showed favourable results with diclofenac, although at the end of the treatment period no statistical differences were observed when compared to baseline. [15]

Diclofenac-based formulations also had been evaluated for treatment of recurrent apthous stomatitis. Three percent diclofenac in 2.5% hyaluronan gel was found to have anti-inflammatory and pain-relieving effects. [16],[17]

Passali et al. [18] compared the efficacy and tolerability of mouthwash formulations of ketoprofen lysine salt (KLS) and benzydamine hydrochloride (BH) in patients with acute inflammation of the pharyngeal cavity. In this randomized, multicenter, parallel-group, single-blind study, the patients were assigned to receive undiluted BH 15 ml (22.5 mg) or KLS 10 ml (160 mg) diluted in 100 ml of water. Both agents were gargled twice daily until pain remission or up to 7 days. The differences between groups in the duration of analgesic effect after the first dose of drug and the time course of pain were found to be statistically significant (P=0.006 andP=0.017, respectively), favouring KLS. A significantly greater proportion of BH-treated patients reported adverse events (P=0.001). They concluded that KLS mouthwash exerts a significantly longer first-application analgesic action with significantly greater local tolerability than BH mouthwash. [18]

Another study in a crossover design compared mouthwash preparations of 0.15% benzydamine HCl and acetaminophen codeine as analgesics following periodontal surgery in 18 chronic periodontitis patients. The analgesic effect of acetaminophen codeine was significantly higher than that of benzydamine HCl following periodontal surgery (P=0.008) in severe cases. However, no significant difference was found between the two when given for mild cases (P=0.9). The study concluded that in cases with mild post-operative pain following periodontal surgery, benzydamine HCl can be prescribed as an analgesic. However, in other cases, this mouthwash should be prescribed along with acetaminophen codeine to reduce systemic drug consumption. [19]

Another randomized, double-blind crossover study evaluated the pain-relieving effect of 2% morphine oral solution in patients suffering from radiotherapy- and/or chemotherapy-induced oral mucositis. Pain alleviation was significant (P<0.001), with duration of pain relief being 123.7±98.2 min for morphine. Results of this study suggest a possible analgesic effect of topical morphine. [20]

The results of the study, particularly in clinical terms, demonstrate that diclofenac mouthwash is characterized by excellent efficacy in relieving pain consequent to oral or periodontal surgical procedures. But, the anti-inflammatory effect was not found to be statistically significant. The reason behind this might be the small sample size. Thus, study on a large sample size would provide more conclusive results.


   Conclusion Top


The new 0.074% diclofenac mouthwash is an effective and tolerable medicinal product for post-surgical symptomatic relief. Thus, it can be an alternative drug for patients who cannot tolerate systemic NSAIDs. Also, by substituting systemic with topical NSAID, systemic drug interactions in patients on anticoagulants and asthmatics can be avoided. This topical formulation is sufficiently effective for pain relief after minor oral surgical procedures without subjecting the patients to systemic side-effects.

 
   References Top

1.Nazaroglou I, Kafas P, Dabarakas N. Post-operative pain in dentistry: A review. Surg J 2008;3:96-103.  Back to cited text no. 1      
2.Haas DA. An update on analgesics for the management of acute postoperative dental pain. J Can Dent Assoc 2002;68:476-82.  Back to cited text no. 2      
3.Dionne RA, Berthold CW. Therapeutic uses of non-steroidal anti-inflammatory drugs in dentistry. Crit Rev Oral Biol Med 2001;12:315-30.  Back to cited text no. 3      
4.Dionne RA, Gordon SM. Nonsteroidal anti-inflammatory drugs for acute pain control. Dent Clin North Am 1994;38:645-67.  Back to cited text no. 4      
5.Salvi GE, Williams RC, Offenbacher S. Nonsteroidal anti-inflammatory drugs as adjuncts in the management of periodontal diseases and peri-implantitis. Curr Opin Periodontol 1997;4:51-8.  Back to cited text no. 5      
6.Williams RC, Jeffcoat MK, Howell TH, Reddy MS, Johnson HG, Hall CM, et al. Topical flurbiprofen treatment of periodontitis in beagles. J Periodontal Res 1988;23:166-9.  Back to cited text no. 6      
7.Jeffcoat MK, Reddy MS, Haigh S, Buchanan W, Doyle MJ, Meredith MP, et al. A comparison of topical ketorolac, systemic flurbiprofen, and placebo for the inhibition of bone loss in adult periodontitis. J Periodontol 1995;66:329-38.  Back to cited text no. 7      
8.Friman C, Johnston C, Chew C, Davis P. Effect of diclofenac sodium, tolfenamic acid and indomethacin on the production of superoxide induced by N-formyl-methionyl-leucyl-phenylalanine in normal human polymorphonuclear leukocytes. Scand J Rheumatol 1986;15:41-6.  Back to cited text no. 8      
9.Wildfeuer A. Effects of non-steroidal anti-inflammatory drugs on human leukocytes. Z Rheumatol 1983;42:16-20.  Back to cited text no. 9      
10.Kirkland O. The suppurative pus pocket; its treatment by the modified flap operation. J Am Dent Assoc 1931;18:1462-70.  Back to cited text no. 10      
11.Lobene RR, Weatherford T, Ross NM, Lamm RA, Menaker L. A modified gingival index for use in clinical trials. Clin Prev Dent 1986;8:3-6.  Back to cited text no. 11      
12.Van der bijl P, Van Eyk AD, Seifart HI, Viljoen I, Jooste M. Transmucosal permeation of topically applied diclofenac and piroxicam. J App Res 2003;3:505-11.  Back to cited text no. 12      
13.Tramθr M, Bassetti C, Metzler C, Morgantini A. Efficacy and safety of mouthwash diclofenac in oral or periodontal surgery. Minerva Stomatol 2001;50:309-14.  Back to cited text no. 13      
14.Weinstein RL. Double blind placebo-controlled study on efficacy, acceptability and safety of mouthwash diclofenac in oral or periodontal postoperative period. Minerva Stomatol 2001;50:315-9.  Back to cited text no. 14      
15.Kostrica R, Rottenberg J, Kvech J, Betka J, Jablonicky J. Randomised, double-blind comparison of efficacy and tolerability of diclofenac mouthwash versus placebo in mucositis of oral cavity by radiotherapy. J Clin Res 2002;5:1-15.  Back to cited text no. 15      
16.Fariba I, Taghi G, Mazdak ES, Maryam T, Hossein SA, Shahla E, et al. The efficacy of 3% diclofenac in 2.5% hyaluronan gel base for the treatment of recurrent aphthous stomatitis (RAS): A double blind study. Egypt Dermatol Online J 2005;1:4.   Back to cited text no. 16      
17.Saxen MA, Ambrosius WT, Rehemtula al-KF, Russell AL, Eckert GJ. Sustained relief of oral aphthous ulcer pain from topical diclofenac in hyaluronan: A randomized, double-blind clinical trial. Oral Surg Oral Med Oral Pathol Oral Radiol Endod 1997;84:356-61.  Back to cited text no. 17      
18.Passΰli D, Volontι M, Passΰli GC, Damiani V, Bellussi L; MISTRAL Italian Study Group. Efficacy and safety of ketoprofen lysine salt mouthwash versus benzydamine hydrochloride mouthwash in acute pharyngeal inflammation: A randomized, single-blind study. Clin Ther 2001;23:1508-18.  Back to cited text no. 18      
19.Khoshkhoonejad AA, Khorsand A, Rastgar F. A comparative study on benzydamine HCL 0.5% and acetaminophen codeine in pain reduction following periodontal surgery. J Dent Med 2004;17:39-44.   Back to cited text no. 19      
20.Vayne-Bossert P, Escher M, de Vautibault CG, Dulguerov P, Allal A, Desmeules J, et al. Effect of topical morphine (mouthwash) on oral pain due to chemotherapy- and/or radiotherapy-induced mucositis: A randomized double-blinded study. J Palliat Med 2010;13:125-8.  Back to cited text no. 20      

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Correspondence Address:
Sangita Agarwal
Department of Periodontics, Institute of Dental Sciences, Bareilly
India
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DOI: 10.4103/0970-9290.70814

PMID: 20930354

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