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

NCT ID: NCT03745105

Last Updated: 2018-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-25

Study Completion Date

2019-12-01

Brief Summary

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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

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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dexamethasone

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

Group Type EXPERIMENTAL

Dexamethasone sodium phosphate

Intervention Type DRUG

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

piroxicam

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

Group Type EXPERIMENTAL

Piroxicam Injectable Solution

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

Mepivacaine HCL

Intervention Type DRUG

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

Interventions

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Dexamethasone sodium phosphate

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

Intervention Type DRUG

Piroxicam Injectable Solution

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Safwa Essam Mohammed Ahmed Abd el-glil

resident at faculty of dentistry cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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

Role: CONTACT

01001259618 ext. 002

References

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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.

Reference Type BACKGROUND
PMID: 27790253 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22432824 (View on PubMed)

Other Identifiers

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CEBD-CU-2018-11-01

Identifier Type: -

Identifier Source: org_study_id

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