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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

Primary Purpose

Postoperative Pain

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Dexamethasone sodium phosphate

Piroxicam Injectable Solution

Mepivacaine HCL

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

dexamethasone

piroxicam

Mepivacaine HCL

Arm Description

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

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

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)

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

number of analgesics taken by the patient

Number of analgesic tablets taken by the patient after endodontic treatment.

Full Information

NCT ID

NCT03745105

First Posted

November 13, 2018

Last Updated

November 20, 2018

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03745105

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

December 25, 2018 (Anticipated)

Primary Completion Date

December 1, 2019 (Anticipated)

Study Completion Date

December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

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

Postoperative Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

42 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dexamethasone

Arm Type

Experimental

Arm Description

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

Arm Title

piroxicam

Arm Type

Experimental

Arm Description

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

Arm Title

Mepivacaine HCL

Arm Type

Active Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Dexamethasone sodium phosphate

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Piroxicam Injectable Solution

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Mepivacaine HCL

Intervention Description

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 Measure Information:

Title

Post operative pain assessed with the Numerical Rating Pain Scale

Description

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 )

Time Frame

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

Secondary Outcome Measure Information:

Title

number of analgesics taken by the patient

Description

Number of analgesic tablets taken by the patient after endodontic treatment.

Time Frame

Until 48 hours after endodontic treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

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

Phone

01001259618

Ext

002

safwaessam91@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27790253

Citation

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.

Results Reference

background

PubMed Identifier

22432824

Citation

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.

Results Reference

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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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