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NCT Number: NCT07233564

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Irreversible Pulpitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saidu College of Dentistry

Swāt, Khyber Pakhtunkhwa, 19200, Pakistan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

College of Physicians and Surgeons Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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