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

NCT ID: NCT07233564

Last Updated: 2025-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-15

Study Completion Date

2026-02-15

Brief Summary

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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

Detailed Description

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Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Dexamathsone 4mg/ml associated with experimental arm

Intervention Type 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

Saline injector(placebo) group

Group Type PLACEBO_COMPARATOR

Normal saline injection

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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College of Physicians and Surgeons Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Aqsa Afzal

AAfzal

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saidu College of Dentistry

Swāt, Khyber Pakhtunkhwa, Pakistan

Site Status

Countries

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Pakistan

Related Links

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Other Identifiers

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117-ERB/023

Identifier Type: -

Identifier Source: org_study_id

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