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Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis

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ClinicalTrials.gov Identifier: NCT03745105
Recruitment Status : Not yet recruiting
First Posted : November 19, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Safwa Essam Mohammed Ahmed Abd el-glil, Cairo University

Brief Summary:
the study is conducted to assess and compare the efficacy of local intraligamentary injection of glucocorticoids(dexamethasone) and NSAID(piroxicam) on reduction of postoperative pain in patients with symptomatic irreversible pulpitis.

Condition or disease Intervention/treatment Phase
Postoperative Pain Drug: Dexamethasone sodium phosphate Drug: Piroxicam Injectable Solution Drug: Mepivacaine HCL Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
Estimated Study Start Date : December 25, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: dexamethasone
Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt)
Drug: Dexamethasone sodium phosphate
prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.

Experimental: piroxicam
Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)
Drug: Piroxicam Injectable Solution
prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam

Active Comparator: Mepivacaine HCL
Pretreatment Intraligamentary injection of 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml (Mepecaine - L, Alexandria Co.-Egypt)
Drug: Mepivacaine HCL
prophylactic intraligamentary supplemental injection 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml




Primary Outcome Measures :
  1. Post operative pain assessed with the Numerical Rating Pain Scale [ Time Frame: up to 48 hours after root canal treatment (At 4,6,12,24 and 48 hours after root canal treatment ). ]
    Intensity of pain after endodontic treatment is recorded by the patient using a numerical rating scale(where 0= no pain ,1-3 =mild pain ,4-6= moderate pain and 7-9= severe pain )


Secondary Outcome Measures :
  1. number of analgesics taken by the patient [ Time Frame: Until 48 hours after endodontic treatment. ]
    Number of analgesic tablets taken by the patient after endodontic treatment.



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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Systemically healthy patient (ASA I or II).
  2. Mandibular Posterior teeth with:

    • Preoperative sharp pain.
    • Absence of widening in the periodontal ligament (PDL).
    • Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).

Exclusion Criteria:

  1. Patients allergic to anesthetics, piroxicam (any other NSAIDs) or dexamethasone (other corticosteroids).
  2. Pregnant or nursing females.
  3. Patients having significant systemic disorder (ASA III or IV).
  4. Hemostatic disorders or anti-coagulant therapy during the last month.
  5. Consumption of opioid or non-opioid analgesics or corticosteroids during the last 12 hrs before treatment.
  6. Retreatment cases.

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): NCT03745105


Contacts
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Contact: Safwa Es. Abd Elglil, B.D.S. (Cairo University) 01001259618 ext 002 safwaessam91@gmail.com

Sponsors and Collaborators
Cairo University

Publications:
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Responsible Party: Safwa Essam Mohammed Ahmed Abd el-glil, resident at faculty of dentistry cairo university, Cairo University
ClinicalTrials.gov Identifier: NCT03745105     History of Changes
Other Study ID Numbers: CEBD-CU-2018-11-01
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pain, Postoperative
Pulpitis
Toothache
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Dexamethasone
Dexamethasone acetate
Piroxicam
Dexamethasone 21-phosphate
Mepivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors