Can Pretreatment With Analgesics Reduce Postendodontic Pain?

NCT ID: NCT07271654

Last Updated: 2025-12-09

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

COMPLETED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-01

Study Completion Date

2025-10-01

Brief Summary

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This randomized controlled trial investigated whether a single dose of diclofenac sodium taken before a root canal procedure can reduce pain in the hours following the treatment. 160 patients with tooth pain from irreversible pulpitis were divided into two groups. One group received 100mg of diclofenac sodium 30 minutes before their procedure, while the other group received no pretreatment. Pain levels were measured at 6, 12, and 24 hours after the procedure. The study found that patients who took diclofenac before treatment were significantly more likely to be pain-free at 6 and 12 hours after the procedure compared to those who did not.

Detailed Description

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This was a parallel-arm, randomized controlled trial conducted in the Department of Operative Dentistry, Saidu College of Dentistry. A total of 160 patients aged 20-60 years with a diagnosis of irreversible pulpitis in vital teeth were enrolled via consecutive sampling. Participants were randomized using a computer-generated sequence with allocation concealment via sealed opaque envelopes. The experimental group (n=80) received a single oral dose of 100 mg diclofenac sodium 30 minutes prior to endodontic treatment. The control group (n=80) received no pretreatment medication. All endodontic treatments were performed by experienced operators using a standardized protocol. The primary outcome was postendodontic pain intensity, assessed using a Visual Analogue Scale (VAS) and categorized as none, mild, moderate, or severe. Pain levels were recorded via structured telephone interviews at 6, 12, and 24 hours post-treatment. Statistical analysis was performed using R software, with group comparisons made using the chi-square test.

Conditions

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Pulpitis - Irreversible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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pre treatment with NSAIDS

Experimental

Group Type EXPERIMENTAL

Pre treatment with NSAIDS

Intervention Type PROCEDURE

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

No pretreatment with NSAIDS.

Intervention Type PROCEDURE

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

No pre treatment with NSAIDS

No pretreatment medication was administered before endodontic treatment.

Group Type ACTIVE_COMPARATOR

Pre treatment with NSAIDS

Intervention Type PROCEDURE

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

No pretreatment with NSAIDS.

Intervention Type PROCEDURE

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

Interventions

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Pre treatment with NSAIDS

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

Intervention Type PROCEDURE

No pretreatment with NSAIDS.

Single oral dose of 100 mg Diclofenac Sodium, administered 30 minutes prior to endodontic treatment.

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

Current use of prophylactic antibiotics.

Pregnancy or lactation.

Mental disabilities.

Systemic illnesses contraindicating endodontic therapy.

Known hypersensitivity or adverse reaction to NSAIDs.

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 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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Faiz ur rahman

Postgraduate Resident, Department of Operative Dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Saidu College of dentistry,Swat

Swat, , Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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SCD-EndoPain-2025

Identifier Type: -

Identifier Source: org_study_id

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