Postoperative Pain After Dexamethasone Injection by Two Techniques in Irreversible Pulpitis

NCT07755306 | Completed Phase 4

• 2 other identifiers: FDASU-Rec IM122413self funded
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized clinical trial to evaluate the effect of dexamethasone in two different techniques on postoperative pain by dividing patients randomly into three groups:

• Group I: buccinator injection of dexamethasone.
• Group II: buccal infiltration of dexamethasone.
• Group III (Control): IANB using local anesthesia only post operative pain will be evaluated subjectively by patients by VAS score after procedure immediately and follow up for 12, 24 and 72 hours and frequency of analgesic intake

Conditions

Post Operative Pain, Acute

Keywords

irreversible pulpitis; postoperative pain; visual analogue score; dexamethasone; buccinator injection; buccal infiltration

Outcome Measures

Primary Outcomes (1)

• visual analogue score (VAS) from 0 to 10

  VAS preoperative ,immediately postoperative,12hrs,24hrs,72hrs

  postoperative 72 hours

Study Arms (3)

buccinator injected by DEX drug

ACTIVE COMPARATOR

patients will receive dexamethasone(2ml/8mg) 1ml per 30 sec slow injection at buccinator muscle as single injection preoperatively

Drug: dexamethasone 8mg

buccal infiltration by DEX drug

ACTIVE COMPARATOR

buccal infiltration of dexamethasone (8mg/2ml) as single injection preoperative

Drug: dexamethasone 8mg

control

NO INTERVENTION

no intervention

Interventions

dexamethasone 8mg DRUG

8mg/2ml injected slowoly 30 sec for 1ml as single injection before the endotreatment

buccal infiltration by DEX drug; buccinator injected by DEX drug

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders 2- Older than age of (18 to 60) years 3- Participants willing to commit for the entire period of the trial and agreed to sign the written consent after full explanation of the study 4- Having a mandibular molar tooth with vital pulp 5- These patients were also suffering from symptomatic irreversible pulpitis ,intermittent or continuous sharp pain that lasts longer after removal of the stimulus 6- Patients with moderate to severe symptoms VAS≥4

You may not qualify if:

• Vulnerable group; pregnant females, mentally ill and diseased patientsetc.… 2- Patients irritable to local anesthesia 3- Patients who are supposed to take plain anesthesia 4- Use of analgesic or antibiotic within 6 hours before the visit 5- Absence of bleeding in the pulp chamber during cavity preparation 6- Severe periodontal disease b- Patients' randomization, allocation and blinding:

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Abeer Abdelhakim Elgendy, Professor

  Faculty of Dentistry, Ain Shams University

  PRINCIPAL INVESTIGATOR

• Mahmoud Fahim, lecturer

  Faculty of Dentistry, Ain Shams University

  STUDY DIRECTOR

• salma masoud, master student

  Faculty of Dentistry, Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student

Model Details: • patients will be randomly divided into three groups: * Group I: will receive buccinator muscle injection of dexamethasone((2ml of 8mg) after inferior alveolar nerve block (IANB) * Group II: will receive buccal infiltration of dexamethasone (2ml of 8mg) after (IANB) * Group III (Control): will receive IANB by anesthetic 4% articaine HCl with 1:100,000 ratio of epinephrine only.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: March 26, 2024
• Primary Completion: December 26, 2025
• Study Completion: April 26, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)