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To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery

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ClinicalTrials.gov Identifier: NCT03519152
Recruitment Status : Completed
First Posted : May 8, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dr.Kshitij .K. Karmkar, Tatyasaheb Kore Dental College

Brief 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.


Condition or disease Intervention/treatment Phase
Chronic Periodontitis Drug: low dose diclofenac Phase 1 Phase 2

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: patient were masked for which tablet they were reciving during the study.
Primary Purpose: Treatment
Official Title: To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery: A Clinical Trail.
Actual Study Start Date : March 20, 2016
Actual Primary Completion Date : May 20, 2017
Actual Study Completion Date : May 21, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: study group one side
All patients were scheduled for open flap debridement surgery on at least two quadrants ≥1 weeks apart.One group will receive Low Dose Diclofenac tablets (25mg Diclofeanc and 325 mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis will be included in study. For each quadrant, a flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure will be recorded in the patient file. Patients will be instructed to complete a pain diary chart for 3 days.
Drug: low dose diclofenac
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 Names:
  • periodontal flap surgery
  • scaling and root planning

Placebo Comparator: study group second side
Other group will receive Diclofeanc (50mg Diclofenac and 325mg paracetamol), BID for 3 days. The patients who are diagnosed with generalized moderate/severe chronic periodontitis were included in study. For each quadrant, aperiodontal flap was raised under local anesthesia (2% lignocaine with 1:80,000 epinephrine). In both the quadrants same technique of anesthesia will be employed. The location and the extent of surgery, volume of the local anesthesia given, and time required to perform the surgical procedure was recorded in the patient file. Patients were instructed to complete a pain diary chart for 3 days.
Drug: low dose diclofenac
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 Names:
  • periodontal flap surgery
  • scaling and root planning




Primary Outcome Measures :
  1. visual analog scale VAS [ Time Frame: 3 days ]
    it messures pain intensity it is an 10cm line anchored by two extremes 0 for no pain and 10 for extreme pain



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Ages Eligible for Study:   17 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Generalized moderate/severe chronic periodontitis
  2. The probing depth (PD) of the surgical sites in the both group ranged from 5 to 8 mm.
  3. The clinical attachment level (CAL) at the surgical sites in both the group ranged from 5 to 9 mm.
  4. Quadrant with the presence of atleast 6 teeth will be selected for study.

Exclusion Criteria:

  1. Tobacco in any form and alcoholics.
  2. Pregnant and lactating mother.
  3. Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic 3 months prior to recruitment for study.
  4. Subjects who had received periodontal treatment within the previous 6 months.
  5. Patient who have history of intolerance or hypersensitivity to Diclofenac and with gastric diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03519152


Locations
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India
Dental
Kolhapur, Maharashtra, India, 416113
Sponsors and Collaborators
Tatyasaheb Kore Dental College
Investigators
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Study Chair: Dilip Khambete, MDS tatayasaheb kore dental college and hospital new pargaon

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Responsible Party: Dr.Kshitij .K. Karmkar, Principle investigator, Tatyasaheb Kore Dental College
ClinicalTrials.gov Identifier: NCT03519152     History of Changes
Other Study ID Numbers: tatyasaheb kore dental college
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Diclofenac
Periodontitis
Chronic Periodontitis
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action