|Year : 2018 | Volume
| Issue : 2 | Page : 156-158
A prospective cross-over clinical study to compare the effect of locally (Mouthwash) or systemically (Tablets) delivered diclofenac sodium after periodontal surgery: A pilot study
Shreeprasad Vijay Wagle, Amit Arvind Agrawal, Rutuja Sankhe
Department of Periodontology and Implantology, MGV's KBH Dental College and Hospital, Nashik, Maharashtra, India
|Date of Web Publication||14-Jun-2018|
Dr. Amit Arvind Agrawal
Department of Periodontology and Implantology, MGV's KBH Dental College and Hospital, Panchavati, Nashik - 422 003, Maharashtra
Source of Support: None, Conflict of Interest: None
Background: Local drug delivery is well known for its advantages over systemic drug therapy. Among nonsteroidal anti-inflammatory drugs, diclofenac is most commonly used analgesic and anti-inflammatory agent. Its mouthwash preparation has gained attention; however, there has not been any cross-over study reported in literature. Methods: Ten patients, indicated for periodontal surgeries, randomly received diclofenac mouthwash for 1 min, twice daily for 4 days, or diclofenac tablet twice daily for 4 days. After at least 15 days, second surgery was performed and mode of therapy was switched. The patient was asked to score Numeric Rating Scale index either personally or telephonically for those 4 days. Collected data were tabulated and analyzed. Results: When unpaired t-test was used for intergroup comparison (mouthwash group and tablet Group) at 95% confidence interval, it showed P = 0.0852 considered not statistically significant. That means pain reduction in mouthwash group is as equal as tablet group. Conclusion: The effect of locally administered diclofenac sodium mouthwash is equivalent to systemically delivered diclofenac sodium tablets. Hence, it can be stated that topical formulation is sufficiently effective for pain relief after periodontal surgical procedures without subjecting the patients to systemic side effects.
Keywords: Diclofenac sodium mouthwash, inflammation, nonsteroidal anti-inflammatory drugs, Numeric Rating Scale index, pain perception, periodontal surgery
|How to cite this article:|
Wagle SV, Agrawal AA, Sankhe R. A prospective cross-over clinical study to compare the effect of locally (Mouthwash) or systemically (Tablets) delivered diclofenac sodium after periodontal surgery: A pilot study. Biomed Biotechnol Res J 2018;2:156-8
|How to cite this URL:|
Wagle SV, Agrawal AA, Sankhe R. A prospective cross-over clinical study to compare the effect of locally (Mouthwash) or systemically (Tablets) delivered diclofenac sodium after periodontal surgery: A pilot study. Biomed Biotechnol Res J [serial online] 2018 [cited 2021 Apr 17];2:156-8. Available from: https://www.bmbtrj.org/text.asp?2018/2/2/156/234463
| Introduction|| |
Diclofenac is a potent anti-inflammatory drug that results in decreased production of prostaglandins (PGs); hence, reduce inflammation or swelling and pain, neutrophil production in vitro, reducing chemotaxis, superoxide, and neutral protease production during inflammation.
Pain is primarily a psychological experience. The etiology of postoperative 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. Tissue damage resulting from surgery induces the production of cyclooxygenase-2, which in turn leads to the synthesis of PGs, which stimulates pain fibers and promotes inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most widely used class of drugs for the management of acute and chronic pain in dentistry. Managing acute postoperative pain is inherent to dental practice. NSAIDs affect the release of β-endorphin during postoperative pain. Clinical trials have shown that NSAIDs are effective in the management of postoperative dental pain. The postoperative sequel of dental procedures also includes inflammation due to tissue injury, most prominently edema. NSAIDs minimize edema, and they are associated with many adverse effects, such as gastric irritability, which leads to a number of contraindications, as dyspepsia and more seriously gastric bleeding. Enteric-coated formulations may reduce the likelihood of dyspepsia; however, they do not prevent gastric bleeding. Recent NSAID research has focused on the development of daily topical gels, toothpastes, and rinses. Because NSAIDs can easily penetrate into the oral and gingival tissues to rapidly inhibit local gingival crevicular fluid PGE2 levels within 1 h due to their lipophilic nature.,
NSAID are increasingly used for perioperative pain relief, while their potential effects on wound healing are scarcely investigated. Diclofenac topical administration might be an alternative for avoiding flushing, pain, and discomfort in wound area, without having the complications of systemic administration. The aim of this present study was to determine and compare the efficacy of 0.074% diclofenac sodium mouthwash with its systemic formulation (50 mg tablet), in pain reduction after periodontal surgery.
| Methods|| |
The study was designed as a randomized, controlled clinical trial. This clinical study was carried out in the Department of Periodontology and Implantology. Ethical clearance was obtained from the Institutional Ethics Committee. Informed consent was obtained from the patients, before the study. A total of 10 patients with periodontal problems attending the dental hospital were selected for the study. Systemically healthy patients requiring at least two periodontal surgeries were included in the study. Patients with the history of intolerance or hypersensitivity to diclofenac, any systemic diseases or condition that affects the oral tissues, pregnant or lactating women, acute gingival or periodontal disease, and patients on oral or systemic NSAIDs therapy for the last 3 months were excluded from the study. Ten patients requiring atleast two periodontal surgeries were operated at gap of at least 15 days. After each surgery, all patients randomly received 0.074% diclofenac sodium mouthwash for 1 min, twice daily for 4 days, or 50 mg diclofenac sodium tablet twice daily for 4 days. The patient was asked to score Numeric Rating Scale (NRS) index either personally or telephonically for those 4 days. After that collected data were tabulated and analyzed.
Mouthwash was prepared in the Department of Pharmacology. Diclofenac sodium in pure powder form, sweetening agent, mint as a flavoring agent, and distilled water as base was used. Mouthwash was dispensed in 200 ml bottle. To maintain the concentration as 0.074%, in 200 ml 0.148 g, diclofenac sodium pure powder was added.
This clinical study is registered in Clinical Trial Registry India (www.ctri.nic.in) with CTRI registration number CTRI/2018/01/011365.
Data pertaining to NRS index scores, of baseline to 14th day were analyzed using unpaired t-test was used for intergroup comparison. The level of significance was taken as P < 0.05.
| Results|| |
Data were collected for 4 days after surgery. When unpaired t-test was used for intergroup comparison (mouthwash group and tablet group) at 95% confidence interval, it showed P = 0.0852, considered not significant t = 1.852 with 14° of freedom. That means pain reduction in mouthwash group is as equal as tablet group. Obtained results are shown in [Table 1] and Diagrammatic representation is given in [Figure 1].
|Figure 1: Intergroup comparison of Numeric Rating Scale index of column A (0.074% diclofenac sodium mouthwash) and column B (50 mg diclofenac sodium tablet)|
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When comparison was made between days mouthwash group showed comparatively more pain reduction in on 1st day after surgery. Diagrammatic representation has shown in [Figure 2].
| Discussion|| |
The present study has shown that 0.074% diclofenac sodium mouthwash is potent analgesic for postoperative periodontal surgery pain relief. It is a better alternative to systemic administration of same drug, i.e. 50 mg diclofenac sodium tablet if given after periodontal surgery. Results showed that maximum amount of pain in both the groups were on the day of surgery that reduced to lower levels from 2nd day [Figure 2]. According to the present study, 0.074% diclofenac mouthwash when given twice daily for 4 days have significant local analgesic effects. It has similar effect to that of systemic administration; this is the main result in the study.
As this study was pilot study, sample size was decided as 10 patients only. There was no such study in the literature where comparison of both groups made in a single patient. Pain is a noxious perception that can be perceived differently in different individuals; for this reason, evaluation of pain perception in should be done in same individual. To overcome this limitation, we took this study, where two identical periodontal surgeries were done in same individual, with 15 days gap between two surgeries. Gap between two periodontal surgeries was kept to minimize the memory effect of NSAIDs after 1st surgery. Hence, bias can be minimized.
After every surgery, NRS index was used to assess the pain reduction. This index has advantage that it can be recorded with telephonic communication between patient and operator. Use of NRS index reduces the patient's ignorance toward recording the data.
While preparing mouthwash in the Pharmacology department, water was used as base for mouthwash, because diclofenac sodium mouthwash has solubility in water as 50 mg in 100 ml of water; this is given in Indian pharmacopeia. For flavoring agent, mint was used. Because mint shows some masking effect on bitter taste of diclofenac sodium powder. Other ingredient was sweetening agent.
Agarwal et al. in 2010, studied the efficacy and acceptability of 0.074% diclofenac containing mouthwash after periodontal surgery in 20 patients they received either diclofenac mouthwash or placebo to rinse who were scheduled for full mouth flap surgery. They observed that spontaneous pain was significantly reduced by diclofenac mouthwash.
Yaghini et al. in 2011 studied the effect of diclofenac mouthwash on periodontal postoperative pain. They studied only 10 patients with flap surgery. One of the two quadrants in each patient was assigned to the test group which was given a diclofenac mouthwash, and the control group was given placebo mouthwash. They have suggested that diclofenac mouthwash alone is not sufficient to control pain for that both the groups were simultaneously advised ibuprofen. In addition, the study could not attribute the analgesic effects to diclofenac mouthwash alone, as all the patients were given ibuprofen systemically.
Mishra et al. in 2017 studied the effect of diclofenac mouthwash on postoperative pain after periodontal surgery. They studied 30 chronic periodontitis patients scheduled for flap surgery. Intragroup comparison showed significant reduction in pain.
Serafini et al. in their study compared the efficacy and tolerability of diclofenac epolamine (DHEP) mouthwash with diclofenac mouthwash (0.074%). They found that DHEP is efficient to reduce pain in the inflammation.
In the future prospects, more number of samples should be included for better bias elimination. Some other clinical parameters should be checked.
| Conclusion|| |
The effect of locally administered diclofenac sodium mouthwash is equivalent to systemically delivered 50 mg diclofenac sodium tablets. 0.074% diclofenac sodium mouthwash has shown more pain reduction on 1st day when compared to 50 mg diclofenac sodium tablet. Hence, it can be stated that topical formulation is sufficiently effective for pain relief after periodontal surgical procedures.
I acknowledge Dr Mangal Borkar, Reader at department of Pharmacology, MGV's KBH Dental College for constant guidance regarding the pharmacological aspect in this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]