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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03745105

Enrollment

Registered

2018-11-19

Start date

2018-12-25

Completion date

2019-12-01

Last updated

2018-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain

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.

Interventions

DRUGDexamethasone sodium phosphate

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

DRUGPiroxicam Injectable Solution

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

DRUGMepivacaine 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

20 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
number of analgesics taken by the patient	Until 48 hours after endodontic treatment.	Number of analgesic tablets taken by the patient after endodontic treatment.

Contacts

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

safwaessam91@gmail.com01001259618

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026