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Table of Contents   
ORIGINAL RESEARCH  
Year : 2019  |  Volume : 30  |  Issue : 1  |  Page : 57-60
A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study


1 Department of Periodontology, Rungta College of Dental Sciences and Research, Bhilai, Chhattisgarh, India
2 Department of Periodontology, Aditya Dental College, Beed, Maharastra, India
3 Department of Periodontology, VYWS Dental College and Hospital, Amravati, Maharastra, India
4 Department of Periodontology, Government Dental College, Raipur, Chhattisgarh, India

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Date of Web Publication20-Mar-2019
 

   Abstract 

Background: Pain is an inevitable outcome of any periodontal surgery. Controlling postoperative pain is of utmost importance so as to increase patient compliance. The present study aims to compare the degree of postoperative analgesia with the use of oral diclofenac sodium and transdermal diclofenac patch following periodontal flap surgery in patients with chronic periodontitis. Materials and Methods: A total of 20 patients requiring full mouth flap surgery were selected for this study. Flap surgery was performed quadrant-wise and transdermal diclofenac patch was applied on the right arm following surgery of one of the quadrants and 100 mg oral diclofenac sodium twice daily was prescribed following surgery of the subsequent quadrant. The postoperative pain was recorded on visual analog scale and pain intensity scale 24 h after the surgery. Results: Both the statistical and clinical observation showed that diclofenac sodium administered transdermally has equal efficacy as compared to drug administered orally. Conclusion: The study concludes that the diclofenac administered transdermally has equal potency in relieving postoperative pain as compared to orally administered diclofenac sodium following modified flap surgery. Transdermal patch has an added advantage of better patient compliance as it does not cause gastric disturbance.

Keywords: Chronic periodontitis, pain, periodontal flap surgery, transdermal diclofenac patch

How to cite this article:
Diwan V, Srinivasa T S, Ramreddy K Y, Agrawal V, Nagdeve S, Parvez H. A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study. Indian J Dent Res 2019;30:57-60

How to cite this URL:
Diwan V, Srinivasa T S, Ramreddy K Y, Agrawal V, Nagdeve S, Parvez H. A comparative evaluation of transdermal diclofenac patch with oral diclofenac sodium as an analgesic drug following periodontal flap surgery: A randomized controlled clinical study. Indian J Dent Res [serial online] 2019 [cited 2019 Jun 25];30:57-60. Available from: http://www.ijdr.in/text.asp?2019/30/1/57/254532

   Introduction Top


The premise of successful periodontal treatment is based not only on the proper surgical technique but also on the prevention and management of postoperative complications. Pain is one of the most commonly experienced symptoms after periodontal surgery. Hence, surgeons strive for an analgesic modality that would provide profound analgesia and would be best tolerated by the patient, hence ensuring patience compliance.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most widely used therapeutic class of analgesic compounds used to relieve postoperative pain.[1],[2] Diclofenac is the most extensively used for postoperative inflammatory conditions, and it affords quick relief of pain and swelling.[3]

Analgesic drugs can be administered in a variety of routes, including oral, parenteral, inhalation as well as transdermal.[4] Oral administration has only 50% of the absorbed dose of diclofenac sodium due to the first pass metabolism.[5]

Recently, drugs can be delivered across the skin to have an effect on the tissues adjacent to the site of application or to have an effect after distribution through the circulatory system.[6] This concept has led to the development of transdermal patches. A transdermal patch or skin patch is a medicated adhesive patch that is placed on the skin to deliver a specific dose of medication through the skin and into the bloodstream.[7] Transdermal drug delivery system provides a means to sustain drug delivery as well as to reduce the intensity of action and thus reduce the side effects associated with its oral administration [Figure 1].
Figure 1: Transdermal diclofenac patch

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Transdermal patches offer several advantages over the oral route such as bypassing first pass metabolism, slow controlled absorption, constant plasma concentration which is maintained for a longer duration, no patient dependence for drug doses, no gastric discomfort, and flexibility of terminating the drug administration by simply removing the patch from the skin.[8],[9]

To the best of our knowledge, no study reported the clinical use of transdermal diclofenac patch following periodontal flap surgery. Hence, the aim of this study was to compare the degree of postoperative analgesia with the use of transdermal diclofenac patch and oral diclofenac sodium following periodontal flap surgery in patients with chronic periodontitis.


   Materials and Methods Top


Patient selection

The study was conducted in the Department of Periodontology, Rungta College of Dental Sciences and Research, Bhilai, Chhattisgarh, India from December 2014 to March 2015. A total of 20 systemically healthy patients with chronic periodontitis were selected from the outpatient department. The study group included 12 male and 8 female patients of age group 20–50 years. Patients were classified as having chronic periodontitis on the basis of the 1999 consensus classification of periodontal diseases.[10] Inclusion criteria were patients with chronic periodontitis requiring flap operation following Phase I therapy, patients with no other systemic ailment. Patients excluded were patients with endodontically involved teeth requiring management, those allergic to NSAIDs, pregnant and lactating females and patients presenting with a history of active peptic ulcerations within the past 6 months.

The ethical clearance for the study was provided by an institutionally approved Ethical Committee, and all the subjects were informed about the nature of the study and the probable side effects of the drugs being administered. A written informed consent was obtained from all the subjects.

Presurgical therapy

A full-mouth supra- and sub-gingival scaling and root planing procedure were performed and oral hygiene instructions were given to the patient before surgery. The periodontal evaluation was performed 4 weeks after phase I therapy to confirm the surgical need. The selected quadrants were randomly divided with the flip of a coin into Group A and Group B. For Group A, following modified flap surgery, transdermal diclofenac patch (200 mg) Nupatch, Zudus Cadila, Ahmedabad was placed on the right arm immediately for 24 h. Modified flap surgery was performed for Group B 1 week after the first surgery and oral diclofenac sodium (100 mg) Voveran SR, Novartis, Bangalore twice a day was prescribed for 24 h. Patients were instructed to continue the same medication for the next 2 days if pain persists. All the surgical procedures were performed by a single operator.

Surgical procedure

A few mL of 0.12% chlorhexidine digluconate rinse was used for intraoral antisepsis, and iodine solution was used for extraoral antisepsis. Local anesthesia was administered following which buccal and lingual sulcular incisions were made and full thickness mucoperiosteal flap reflected. Meticulous debridement and root planing were performed using ultrasonic instruments Biosonic s1 Coltene Whaledent and area-specific curettes Gracey Curettes, Hu-Friedy. Mucoperiosteal flap was repositioned and secured in place with 3–0 nonresorbable silk suture Mersilk, Johnson and Johnson, HP. For Group A, transdermal patch was placed on the right arm for 24 h [Figure 2]. Antibiotic (500 mg amoxicillin, 3 times/day for 3 days) was prescribed, and the patient was discharged with pain assessment chart.
Figure 2: Transdermal diclofenac patch applied on the right arm of the patient

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Postsurgical pain assessment

Pain was the primary variable which was assessed. Two subjective scales were employed to record the pain postoperatively. The visual analog scale (VAS) with 6 points (no pain, slight, mild, moderate, severe, horrible) and pain intensity scale (PIS) with 5 points (no pain, very mild pain, mild pain, moderate pain, severe pain) were used to assess the pain. Patients were recalled after 24 h and scores were recorded. Apart from pain, any other discomfort which a patient may encounter during 24 h postoperative period was also noted.

Statistical analysis

Data were analyzed using SPSS Version 11.5 software, SPSS Inc., Chicago, USA. Power calculation was performed before the study was initiated. To achieve an 80% power keeping α at 0.05 and to detect a difference in parameters between groups, 18 quadrants/group were required which was rounded to 20 quadrants/group, hence 20 patients (40 quadrants) were selected for the study. Mann-Whitney U-test was employed to analyze the difference between the groups (Group A and Group B). The comparison was done between the groups for both VAS and PIS scales and value of P < 0.05 was considered to be significant.


   Results Top


Twenty patients initially enrolled completed the study. None of the patients reported significant swelling in the operated area. Mean age of the patient was 35.05 years. Twenty-eight patients were selected for the study of which 8 were excluded from the study. 20 patients (40 quadrants) completed the study [Figure 3]. Twelve patients reported no difference for VAS and PIS scales for Group A and Group B. Two patients with transdermal patch took supportive medication. Four patients reported gastric irritation with oral diclofenac sodium. The mean values for transdermal patch group in VAS and PIS scales were 0.6 ± 0.51 and 1.2 ± 0.63, respectively. Similarly, the mean values for oral diclofenac sodium group in VAS and PIS scale were 0.8 ± 0.42 and 1.6 ± 0.8, respectively [Table 1]. There was no statistically significant difference between transdermal patch group and oral diclofenac group for both VAS and PIS scale [Figure 4].
Figure 3: Flow diagram of the study

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Table 1: Statistical analysis of the groups

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Figure 4: Graph depicting the values for the groups

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   Discussion Top


Dealing with postoperative pain remains an arena for never ending research with better formulations and modalities continuously replacing obsolete ones. Postsurgical pain has often been a nemesis for surgeons and patients alike due to considerable degree of inflammatory response involved.

NSAIDs are among the most widely used medications in the world due to their demonstrated efficacy in reducing pain and inflammation.[11]

Diclofenac sodium, an aryl acetic acid derivative[3],[12] is the commonly employed NSAID either as a sole agent or in combination with other NSAIDs. It is nonselective cox inhibitor (traditional NSAID) which acts by inhibition of the proinflammatory enzyme cyclooxygenase.[3],[13] It can be delivered through the skin as a transdermal patch. An advantage of a transdermal drug delivery route over other types such as oral, topical, etc., is that it provides a controlled release of the medicament into the circulation.[14]

The transdermal diclofenac patch (Nu Patch) is used to relieve mild to moderate postoperative pain. It is applied once for the duration of 24 h and produces rapid pain relief with minimal or no side effects. The patch is to be applied on the skin, preferably in an area devoid of any hair.[1],[15] The patch achieves plasma levels ranging between 20 and 50 ng/ml,[15] which is lesser when compared to the oral route, but these levels are sustained for a longer time.[6],[15]

The transdermal patch may include the following components: (i) Liner – protects the patch during storage. The liner is removed before use, (ii) Adhesive – serves to adhere the components of the patch together along with adhering the patch to the skin and also acts as drug reservoir, (iii) Release liner – controls the release of the drug from the reservoir, (iv) Backing – protects the patch from the outer environment.[6],[16]

Transdermal patch works on crystal reservoir technology.[6] This efficient way of releasing a drug is based on the over saturation of an adhesive polymer with medication, thus forcing a partial crystallization of the drug. The presence of both molecular solute and solid crystal forms allow for a considerably higher concentration and consistent supply of the drug in each patch. As the skin absorbs the molecular solute, crystals re-dissolve to maintain maximum thermodynamic activity at the site of contact. Thus, it ensures continuous controlled delivery of the drug into the circulation.[17],[18]

In previous studies, transdermal patches have been shown to be equally effective with an advantage over the orally administered drugs. Authors in the past have compared the efficacy of transdermal diclofenac patch with orally administered diclofenac sodium following root coverage procedure, and they concluded transdermal patch to be better in increasing patient compliance.[19] This study is in accordance with the above-mentioned study.

Similarly, transdermal patch has been shown to have a better efficacy over orally administered diclofenac sodium following third molar disimpaction and multiple premolar extractions.[1],[15]

The transdermal route is indeed desirable, but there is one obstacle: whereas the function of the GI tract is to render ingested material suitable for absorption, the skin's function is to keep things out of the body. The major barrier within the skin is the stratum corneum which is impermeable to water and behaves as a tough, flexible membrane. However, it allows passage of certain chemical substances. These chemical substances are characterized by low molecular weight (≤500 Da), lipophilicity, and effectiveness at low dosage.[6]

Transdermal patches can be the choice of the analgesic modality of near future with its equivalent or at times better efficacy over oral doses and a better patient acceptance.


   Conclusion Top


The diclofenac administered transdermally has equal potency in relieving postoperative pain as compared to orally administered diclofenac sodium following periodontal flap surgery. However, long-term studies with a larger sample size along with other available analgesic modalities need to be carried out to validate this finding.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

 
   References Top

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Bachalli PS, Nandkumar H, Srinath N. A comparative study of diclofenac transdermal patch against oral diclofenac for pain control following removal of mandibular impacted third molars. J Maxillofac Oral Surg 2009;8:167-72.  Back to cited text no. 15
    
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Correspondence Address:
Dr. Vikas Diwan
House No: 13/144, Balaji Ward, Jagdalpur - 494 001, Chhattisgarh
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijdr.IJDR_84_17

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