Effectiveness if Premedication With Single Dose Piroxicam and Prednisolone After a Single Visit Root Canal Treatment .

NCT ID: NCT04124822

Last Updated: 2019-10-11

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

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-30

Study Completion Date

2019-07-15

Brief Summary

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Two drugs (Piroxicam and Prednisolone)are being compared for post operative endodontic pain after a single visit root canal treatment for 74 hours.

Detailed Description

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To evaluate effectiveness of single dose premedication with piroxicam(20mg) and prednisolone(20mg) on post endodontic pain after a single visit root canal treatment .

patient will be recalled every day for 4 days to know the pain scale using visual analogue scale .

Conditions

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Post-operative Endodontic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

subjects are randomly placed into one of the three groups: Placebo, Piroxicam (20 mg), Prednisolone (20 mg). The drugs will be given thirty minutes before procedure starts,followed by one visit root canal procedure. Postoperative pain will be evaluated up to 96 hours interval using a visual analog scale.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
It is a double blinded study in which investigator /caregiver and participant will be blinded and 3rd person not in the study will be dispatching drugs from the coded bottles .

Study Groups

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control

group 1 , is no intervention group in which root canal procedure will be done without drug as ideal protocol .

Group Type NO_INTERVENTION

No interventions assigned to this group

Piroxicam

group 2 is given Piroxicam 20 mg half an hour before root canal treatment to manage post operative pain.

Group Type EXPERIMENTAL

Piroxicam 20 mg

Intervention Type DRUG

Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels

Prednisolone

group 3 is given Prednisolone 20mg half an hour before root canal treatment to manage post operative pain.

Group Type EXPERIMENTAL

prednisolone 20 mg

Intervention Type DRUG

prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain

Interventions

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Piroxicam 20 mg

Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels

Intervention Type DRUG

prednisolone 20 mg

prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient ages from 20-40 years(28).
2. Single rooted tooth with symptomatic irreversible pulpitis.
3. With no analgesic or anti-inflammatory drug taken within a week period before procedure.

Exclusion Criteria

1. Patients presenting with any systemic disease
2. Patients already taking premedication for endodontic pain.
3. Pregnant or lactating patients.
4. Multirooted teeth.
5. Teeth with Pulpal necrosis.
6. Previously treated or initiated root canal treatment.
7. Patient presenting with allergy due to drug
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Anum Tanwir , MDS

MDS trainee (operative dentistry)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anum Tanwir, BDS

Role: PRINCIPAL_INVESTIGATOR

Dow University of Health Sciences

Locations

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DUHS

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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Tanwir A, Ahmed S, Akhtar H, Wahid U, Shakoor Abbasi M, Ahmed N. Effectiveness of Single Dose Premedication of Piroxicam and Prednisolone on Post Endodontic Pain in One Visit Root Canal Treatment: A Randomized Clinical Trial. Eur Endod J. 2022 Oct;7(3):187-192. doi: 10.14744/eej.2022.24119.

Reference Type DERIVED
PMID: 36217645 (View on PubMed)

Other Identifiers

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Dikiohs2013

Identifier Type: -

Identifier Source: org_study_id

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