NCT03745105

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Dec 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 19, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

December 25, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

November 23, 2018

Status Verified

November 1, 2018

Enrollment Period

11 months

First QC Date

November 13, 2018

Last Update Submit

November 20, 2018

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Post operative pain assessed with the Numerical Rating Pain Scale

    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 )

    up to 48 hours after root canal treatment (At 4,6,12,24 and 48 hours after root canal treatment ).

Secondary Outcomes (1)

  • number of analgesics taken by the patient

    Until 48 hours after endodontic treatment.

Study Arms (3)

dexamethasone

EXPERIMENTAL

Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt)

Drug: Dexamethasone sodium phosphate

piroxicam

EXPERIMENTAL

Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)

Drug: Piroxicam Injectable Solution

Mepivacaine HCL

ACTIVE COMPARATOR

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

Interventions

Dexamethasone sodium phosphateDRUG

prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.

dexamethasone
Piroxicam Injectable SolutionDRUG

prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam

piroxicam
Mepivacaine HCLDRUG

prophylactic intraligamentary supplemental injection 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml

Mepivacaine HCL

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy patient (ASA I or II).
  • 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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Mehrvarzfar P, Esnashari E, Salmanzadeh R, Fazlyab M, Fazlyab M. Effect of Dexamethasone Intraligamentary Injection on Post-Endodontic Pain in Patients with Symptomatic Irreversible Pulpitis: A Randomized Controlled Clinical Trial. Iran Endod J. 2016 Fall;11(4):261-266. doi: 10.22037/iej.2016.2.

    PMID: 27790253BACKGROUND

  • Atbaei A, Mortazavi N. Prophylactic intraligamentary injection of piroxicam (feldene) for the management of post-endodontic pain in molar teeth with irreversible pulpitis. Aust Endod J. 2012 Apr;38(1):31-5. doi: 10.1111/j.1747-4477.2010.00274.x. Epub 2010 Oct 24.

    PMID: 22432824BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

dexamethasone 21-phosphateMepivacaine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Safwa Es. Abd Elglil, B.D.S. (Cairo University)

CONTACT

01001259618safwaessam91@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident at faculty of dentistry cairo university

Study Record Dates

First Submitted

November 13, 2018

First Posted

November 19, 2018

Study Start

December 25, 2018

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

November 23, 2018

Record last verified: 2018-11