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

Primary Purpose

Chronic Periodontitis

Status
Completed
Phase
Phase 1
Locations
India
Study Type
Interventional
Intervention
low dose diclofenac
Sponsored by
Tatyasaheb Kore Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Periodontitis

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dental

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

study group one side

study group second side

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

visual analog scale VAS
it messures pain intensity it is an 10cm line anchored by two extremes 0 for no pain and 10 for extreme pain

Secondary Outcome Measures

Full Information

First Posted
February 1, 2017
Last Updated
May 8, 2018
Sponsor
Tatyasaheb Kore Dental College
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1. Study Identification

Unique Protocol Identification Number
NCT03519152
Brief Title
To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery
Official Title
To Compare Efficacy of Low Dose Diclofenac (25mg) in Management of Postoperative Pain After Periodontal Flap Surgery: A Clinical Trail.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 20, 2016 (Actual)
Primary Completion Date
May 20, 2017 (Actual)
Study Completion Date
May 21, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tatyasaheb Kore Dental College

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Periodontitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
Participant
Masking Description
patient were masked for which tablet they were reciving during the study.
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group one side
Arm Type
Experimental
Arm Description
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.
Arm Title
study group second side
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
low dose diclofenac
Other Intervention Name(s)
periodontal flap surgery, scaling and root planning
Intervention Description
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.
Primary Outcome Measure Information:
Title
visual analog scale VAS
Description
it messures pain intensity it is an 10cm line anchored by two extremes 0 for no pain and 10 for extreme pain
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Generalized moderate/severe chronic periodontitis The probing depth (PD) of the surgical sites in the both group ranged from 5 to 8 mm. The clinical attachment level (CAL) at the surgical sites in both the group ranged from 5 to 9 mm. Quadrant with the presence of atleast 6 teeth will be selected for study. Exclusion Criteria: Tobacco in any form and alcoholics. Pregnant and lactating mother. Patients with history of systemic ailments, patients under ant-inflammatory/antibiotic 3 months prior to recruitment for study. Subjects who had received periodontal treatment within the previous 6 months. Patient who have history of intolerance or hypersensitivity to Diclofenac and with gastric diseases
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dilip Khambete, MDS
Organizational Affiliation
tatayasaheb kore dental college and hospital new pargaon
Official's Role
Study Chair
Facility Information:
Facility Name
Dental
City
Kolhapur
State/Province
Maharashtra
ZIP/Postal Code
416113
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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