Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars
Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial
1 other identifier
interventional
60
0 countries
N/A
Brief Summary
The aim of the study is to evaluate the effect of piroxicam (20mg) compared to placebo on post-endodontic pain of single-visit endodontic treatment of non-vital mandibular molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2019
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJuly 16, 2019
July 1, 2019
1 year
June 25, 2019
July 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 6 hours after the first visit
6 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 12 hours after the first visit
12 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 24 hours after the first visit
24 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 48 hours after the first visit
48 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 72 hours after the first visit
72 hours
Postendodontic pain using a pain-measuring scale
Postoperative pain is measured using the Numerical Rating Scale (NRS) which is an 11-point scale from 0-10 where 0 represents no pain and 10 represents the worst pain measured 7 days after the first visit
7 days
Secondary Outcomes (1)
Analgesic medication intake incidence
7 days
Study Arms (2)
Piroxicam drug
EXPERIMENTAL20 mg piroxicam
Placebo
PLACEBO COMPARATORplacebo
Interventions
Eligibility Criteria
You may qualify if:
- Patients aging between 18-50 years old
- Patients with mandibular molar with non-vital pulp.
- Systemically- healthy patients (ASA I or II).
- Patients who agree to attend for recall appointments and provide a written consent.
You may not qualify if:
- Pregnant or lactating female patients.
- Patients allergic to piroxicam.
- History of peptic ulceration.
- Periapical abscess, fistula.
- Non-restorable teeth.
- Moderate or severe marginal periodontitis i.e. pocket probe\>3mm.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Related Publications (4)
Konagala RK, Mandava J, Pabbati RK, Anupreeta A, Borugadda R, Ravi R. Effect of pretreatment medication on postendodontic pain: A double-blind, placebo-controlled study. J Conserv Dent. 2019 Jan-Feb;22(1):54-58. doi: 10.4103/JCD.JCD_135_18.
PMID: 30820083BACKGROUNDJoshi N, Mathew S, George JV, Hegde S, Bhandi S, Madhu KS. Comparative evaluation of the efficacy of two modes of delivery of Piroxicam (Dolonex((R))) for the management of postendodontic pain: A randomized control trial. J Conserv Dent. 2016 Jul-Aug;19(4):301-5. doi: 10.4103/0972-0707.186454.
PMID: 27563175BACKGROUNDNekoofar MH, Sadeghipanah M, Dehpour AR. Evaluation of meloxicam (A cox-2 inhibitor) for management of postoperative endodontic pain: a double-blind placebo-controlled study. J Endod. 2003 Oct;29(10):634-7. doi: 10.1097/00004770-200310000-00005.
PMID: 14606784BACKGROUNDMohamed AF, El-Asfouri HA, Amin SAW. Effect of sublingual fast-dissolving piroxicam premedication on postoperative pain experience in mandibular molars with non-vital pulp: a randomized double-blind controlled trial. Head Face Med. 2024 Sep 21;20(1):52. doi: 10.1186/s13005-024-00453-x.
PMID: 39306665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Asmaa FE Mohamed, B.D.S
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- The study will be participant and operator-blind where the participant and operator will not know the intervention done.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Postgraduate Student, Department of Endodontics, Faculty of Dentistry, Cairo University
Study Record Dates
First Submitted
June 25, 2019
First Posted
June 26, 2019
Study Start
September 1, 2019
Primary Completion
September 1, 2020
Study Completion
December 1, 2020
Last Updated
July 16, 2019
Record last verified: 2019-07