To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Pain, Postoperative
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Pain after periodontal surgical procedures is a common manifestation. The perception of pain
      is highly subjective and varies substantially among individuals. Many factors affect pain
      perception, such as the nature, duration, and extent of the surgery and psychological aspects
      (e.g., stress and anxiety). Pain after periodontal surgery is an example of acute dental pain
      of mild to moderate severity. Non-steroidal anti-inflammatory drugs (NSAIDs) have a
      significant advantage in the control of pain after periodontal or oral surgical procedures.

      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.

      As Diclofenac associated with many adverse effects, like gastric irritability, nausea,
      headache, dizziness. Undesirable effects may be minimized by using the lowest effective dose
      for the shortest duration necessary to control symptoms. As many of clinical trials have
      suggested Diclofeanc 50 mg alleviates the postoperative pain. So main aim of the study was to
      evaluate the effectiveness of low dose Diclofenac(25mg) in reducing the post operative pain
      after periodontal flap surgeries. Thus comparing the effects of low dose Diclofenac and
      Diclofenac 50mg for reducing post-operative pain.
    

Detailed description: 
      The present split mouth, single blind randomized controlled clinical trial was carried out in
      the

      Department of Periodontology and source of the patients was from the outpatient section of
      Tatyasaheb Kore Dental College & Research Centre, New Pargaon.

      Patients were enrolled in the study between November 2016 and June 2017. Based ' on the power
      of study that was l 80% with alpha of 0.05 with SD of ±1.47, we required

      18 experimental quadrants and 18 control quadrants. Considering 10% dropout " sample size was
      finalized at 20.

      The study included 20 patients [14 males and 6 females] with generalized chronic
      periodontitis.

      With age ranging from 17-55 years, the selected patient had atleast 20 natural teeth, and
      with no history of previous periodontal therapy preceding six months of study. Medically
      compromised patients, pregnant and lactating mothers, smokers and alcoholics, and those with
      a history of taking anticoagulant therapy, patient reporting intake of steroidal or
      non-steroidal antiinflammatory drugs (previous 3 months) or antibiotics in previous six month
      were excluded from the study. Patient with known hypersensitivity to Diclofenac and gastric
      diseases were also not considered.

      The protocol of the study was explained to each patient, and informed consent was obtained
      after explanation of the study. A split mouth design was used. A total of 40 quadrants in 20
      patients (two quadrants in each patient) were operated. Complete medical evaluations of all
      the patients were done to rule out any systemic conditions.

      All patients were scheduled for open flap debridement surgery on at least two quadrants >1
      weeks apart. Each quadrant was randomly allocated (coin test) a different medication regimen
      for postoperative pain control. So in one patient two quadrant were operated one quadrant
      received Low Dose Diclofenac tablets (25mg Diclofenac and 325 mg paracetamol), BID for 3
      days, whereas the other operated quadrant received Diclofenac (50mg Diclofenac and 325mg
      paracetamol), BID for 3 days.

      A flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both
      the quadrants same technique of anesthesia was employed. The location and the extent of
      surgery, volume of the local anesthesia given, and time required to perform the surgical
      procedure was noted in the patient file (Table/Fig 4). Participants were instructed to
      complete VAS chart once in the morning and once in evening for 3 days with the gap of 8 hours
      in between and recalled on 4thday and asked about any discomfort noted during following
      postoperative dayss in the form of questionnaire [Table/fig 5]. For measuring the clinical
      pain intensity the participants were provided with the visual analog scale (VAS). The VAS
      consists of a 10-cm line anchored by two extremes: no pain and pain that could not be more
      severe.

      Participants were asked to make a mark on the line representing their level of perceived
      pain.

      STATISTICAL ANALYSIS:- Data were analyzed using statistical software. The P value was set at
      0.05 for all tests. The postsurgical pain parameters were presented as mean - SD and were
      compared using the independent t test.

      While for the intra group analysis repeated measures of analysis of variance (ANOVA) test was
      used and data were presented as mean.
    

Intervention name(s): low dose diclofenac
Intervention type(s): Drug
Intervention description(s): it is a split mouth design in which one side recieved low dose diclofenac(25mg) after periodontal flap surgery and in next week second side will recieve diclofenac 50mg after flap surgery.
Other intervention name(s): periodontal flap surgery; scaling and root planning
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment