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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03745105
• Other study ID #: CEBD-CU-2018-11-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 25, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2018
• Source: Cairo University
• Contact: Safwa Es. Abd Elglil, B.D.S. (Cairo University)
• Phone: 01001259618
• Email: safwaessam91[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 42
• Est. completion date: December 1, 2019
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Pulpitis
• Toothache

Intervention

Drug:
• Dexamethasone sodium phosphate
prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.
• Piroxicam Injectable Solution
prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. — View 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. — View Citation

Outcome

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