Effect of Pre-medication With Anti-inflammatory Drugs(Ibuprofen and Dexamethasone)on Post-Endodontic Pain

NCT ID: NCT06980870

Last Updated: 2025-05-20

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

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-15

Study Completion Date

2025-06-15

Brief Summary

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Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain with symptomatic irreversible pulpitis

Detailed Description

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Study will be conducted after the approval of Institutional Ethics Review Committee, AFID (ANX "A").

A total of 130 entitled patients reporting to Operative Dentistry Department, Armed Forces Institute of Dentistry will be invited for participation in this study. The procedure will be explained to the patients and their parents in Urdu language and a written informed consent will be taken (ANX "B") They will be screened for inclusion by taking history, performing relevant clinical examination and necessary tests along with peri-apical radiographs. Patients fulfilling the inclusion criteria will be divided into two groups using consecutive non random sampling.

Group 1: Patients treated with premedication of Non steroidal anti inflammatory drug (Ibuprofen) Group 2: Patients treated with premedication of Steroidal anti inflammatory drug (Dexamethsone)

Both groups will receive medication 15 mins before intiating root canal treatment. Root canal treatment will then be initiated under local anesthesia and rubber dam isolation. Working length will be taken 1mm from radiographic apex with apex locator and will be confirmed with radiograph. The root canals will be instrumented with ProTaper Next system under copious irrigation with 5.25% sodium hypochlorite (NaOCl). Patency will be confirmed with a #10 K file between each instrument change. The root canals will be flushed with 5 mL of 17% EDTA solution. To control the microbiological impact on post-operative pain calcium hydroxide will be used as an intra-canal medicament and likewise 5.25% sodium hypochlorite as an irrigant in both groups. Following instrumentation and calcium hydroxide placement in the canal using lentulo spirals, the cavity will be temporarily sealed with cavit.

At the end of every appointment, patient will be given a visual analogue scale. The patient will be advised to mark the line corresponding with the intensity of his pain at 24, 48 and 72 hours after the first visit. The patient will be recalled after one week for obturation and final full coverage restoration. Analgesics will be prescribed in case of severe intolerable pain.

Conditions

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Post-endodontic Pain Ibuprofen Dexamethasone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pain with ibuprofen

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Group Type ACTIVE_COMPARATOR

Anti-inflammatory drug (ibuprofen)

Intervention Type DRUG

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Pain with dexamethasone

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Group Type ACTIVE_COMPARATOR

Anti-inflammatory drug (dexamethsaone)

Intervention Type DRUG

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Interventions

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Anti-inflammatory drug (ibuprofen)

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Intervention Type DRUG

Anti-inflammatory drug (dexamethsaone)

Effect of pre-medication with anti-inflammatory drugs(ibuprofen and dexamethasone)on Post-Endodontic pain

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Permanent teeth with acutely inflamed pulp without swelling or draining sinus.
2. Patients of either gender aged between 18-50 years old.
3. Systemically healthy patients.
4. Patients who agree to attend for recall appointments and provide a written consent.

Exclusion Criteria

1. Patients on preoperative analgesics and antibiotics.
2. Teeth with calcified canals and previously treated teeth.
3. Pregnant and lactating mothers.
4. Patients who are immunocompromised, anxious and mentally handicapped.
5. Patients who are allergic to any of the test medications.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Armed Forces Institute of Dentistry, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Qurat-ul-ain Abbasi

Post-Graduate Resident Operative Dentistry & Endodontic

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Quratulain Abbasi, BDS

Role: PRINCIPAL_INVESTIGATOR

AFID

Locations

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Armed Forces Institute Of Dentistry

Rawalpindi, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Quratulain Abbasi, BDS

Role: CONTACT

00923315317467

Maha Ali Mirza, BDS

Role: CONTACT

00923365605412

Facility Contacts

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Quratulain Abbasi, BDS

Role: primary

00923315317467

Maha Ali Mirza, BDS

Role: backup

009923365605412

Other Identifiers

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Ibuprofen versus Dexamethasone

Identifier Type: -

Identifier Source: org_study_id

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