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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

Tracking Information
First Submitted Date  ICMJE November 13, 2018
First Posted Date  ICMJE November 19, 2018
Last Update Posted Date November 22, 2018
Estimated Study Start Date  ICMJE December 25, 2018
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2018)
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 )
Original Primary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
Post operative pain assessed with the Numerical Rating Pain Scale [ Time Frame: up to 48 hours after root canal tretment (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 )
Change History Complete list of historical versions of study NCT03745105 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 15, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Evaluation of the Effect of Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • Drug: Dexamethasone sodium phosphate
    prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.
  • Drug: Piroxicam Injectable Solution
    prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam
  • 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
Study Arms  ICMJE
  • Experimental: dexamethasone
    Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt)
    Intervention: Drug: Dexamethasone sodium phosphate
  • Experimental: piroxicam
    Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)
    Intervention: Drug: Piroxicam Injectable Solution
  • 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)
    Intervention: Drug: Mepivacaine HCL
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: November 15, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Safwa Es. Abd Elglil, B.D.S. (Cairo University) 01001259618 ext 002 safwaessam91@gmail.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03745105
Other Study ID Numbers  ICMJE CEBD-CU-2018-11-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Safwa Essam Mohammed Ahmed Abd el-glil, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Cairo University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP