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

Not Applicable

• Conditions: Postoperative Pain
• Interventions: Drug: Piroxicam Injectable Solution; Drug: Dexamethasone sodium phosphate; Drug: Mepivacaine HCL

• Registration Number: NCT03745105
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-11
• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Last Update Submitted: 2018-11-20
• Last Update Posted: 2018-11-23
• Study Start: 2018-12-25
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 42

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
piroxicam	Piroxicam Injectable Solution	Pretreatment intraligamentary injection of 0.4 mL of 20 mg mL-1 piroxicam (Feldene, Pfizer, Egypt)
dexamethasone	Dexamethasone sodium phosphate	Pretreatment intraligamentary injection of 0.4 mL of 8 mg/2 mL dexamethasone (Dexamethasone, AMRIYA pharmaceutical, Egypt)
Mepivacaine HCL	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)

Primary Outcome Measures

Name	Time	Method
Post operative pain assessed with the Numerical Rating Pain Scale	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

Name	Time	Method
number of analgesics taken by the patient	Until 48 hours after endodontic treatment.	Number of analgesic tablets taken by the patient after endodontic treatment.