Comparison of Pain Between Supraperiosteal Injection of Dexamethasone Versus Placebo on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis

NCT07233564 | Active Not Recruiting DMC

• 1 other identifier: 117-ERB/023
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled trial aims to compare the effectiveness of supra periosteal injection of dexamethasone versus placebo in reducing post operative pain in teeth diagnosed with symptomatic irreversible pulpitis. A total of 44 patients will be randomly assigned into two groups: Group A will receive a supra periosteal injection of dexamethasone(4mg/ml), and Group B will receive a similar injection of normal saline as placebo. post operative pain will be assessed at 6hr,24hr and 48hr using a VAS Analogue Scale, with the final outcome measured at 24hrs. the study will help determine whether local dexamethasone injection is effective in minimizing postoperative pain

Conditions

Irreversible Pulpitis

Keywords

Effect of dexamthasone on irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

• Post operative pain

  Pain will be measured using a 10 - point Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6= moderate pain, and 7-10 = severe pain the absence of pain will be considered as effective treatment

  24hr after endodontic treatment

Study Arms (2)

Dexamethasone injection group

EXPERIMENTAL

participant in this arm will receive a supraperiosteal injection of 4mg/ml dexamethasone at the mucobuccal fold prior to endodontic treatment for symptomatic irreversible pulpitis

Drug: Dexamathsone 4mg/ml associated with experimental arm

Saline injector(placebo) group

PLACEBO COMPARATOR

Drug: Normal saline injection

Interventions

Dexamathsone 4mg/ml associated with experimental arm DRUG

particappant in this group will receive a supraperiosteal injection of dexamethasone 4mg/ml at the mucbuccal fold before endodontic treatment of teeth with symptomatic irreversible pulpitis

Dexamethasone injection group

Normal saline injection DRUG

particapant in this group will receive a supraperiosteal injection of normal saline at mucobuccal fold in the similar manner and volume as the experoimental drug

Saline injector(placebo) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients age 18 or above 18 year old (to have complete apex formation)
• Patient with normal periapical area (no pain on percussion).
• Patient who have not received any preoperative analgesic and antibiotic in last one month.

You may not qualify if:

• Pregnancy and Lactation because radiographs are contraindicated.
• Moderate to severe periodontal disease because teeth are not salvageable.
• Patient with nonvital teeth diagnose via cold test and EPT.
• Patient with known sensitivity to dexamethasone by history.
• Patients whose medical history include a history of certain illnesses, such as HIV, heart disease, or epilepsy (conditions that can affect a patient's rate of healing).

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

Study Sites (1)

Saidu College of Dentistry

Swāt, Khyber Pakhtunkhwa, 19200, Pakistan

Location

Related Links

• Related Info

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: AAfzal

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: July 15, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 15, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

PA (1)