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

November 14, 2025 updated by: Aqsa Afzal, College of Physicians and Surgeons Pakistan

Comparison of Pain Between Supraperiosteal Injection of Dexamethasone Versus Placebo on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Khyber Pakhtunkhwa
      • Swāt, Khyber Pakhtunkhwa, Pakistan, 19200
        • Saidu College of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dexamethasone injection group
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
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
Placebo Comparator: Saline injector(placebo) group
Drug: Normal saline injection
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operative pain
Time Frame: 24hr after endodontic treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

College of Physicians and Surgeons Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 15, 2026

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

November 14, 2025

First Posted (Actual)

November 18, 2025

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 117-ERB/023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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