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

NCT03519152 | Completed Phase 1

• 1 other identifier: tatyasaheb kore dental college
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  3 days

Study Arms (2)

study group one side

EXPERIMENTAL

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

study group second side

PLACEBO COMPARATOR

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

Interventions

low dose diclofenac DRUG

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.

Also known as: periodontal flap surgery, scaling and root planning

study group one side; study group second side

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tatyasaheb Kore Dental College: lead

Study Sites (1)

Dental

Kolhāpur, Maharashtra, 416113, India

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Diclofenac; Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Dilip Khambete, MDS

  tatayasaheb kore dental college and hospital new pargaon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patient were masked for which tablet they were reciving during the study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: May 8, 2018
• Study Start: March 20, 2016
• Primary Completion: May 20, 2017
• Study Completion: May 21, 2017
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)