Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars
Primary Purpose
Non-Vital Tooth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Piroxicam
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Non-Vital Tooth focused on measuring Piroxicam, Postendodontic pain, analgesic intake
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Piroxicam drug
Placebo
Arm Description
20 mg piroxicam
placebo
Outcomes
Primary Outcome Measures
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
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
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
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
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
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
Secondary Outcome Measures
Analgesic medication intake incidence
Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03998826
Brief Title
Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars
Official Title
Effect of Piroxicam Premedication on Postendodontic Pain in Mandibular Molars With Non-vital Pulp: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
September 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
Patients will be clinically and radiographically examined and their eligibility will be assessed. Eligible patients will be treated in one visit.
Patients will be randomly assigned to one of 2 groups: experimental group (premedication with 20 mg of piroxicam) and the control group (premedication with placebo). Each participant will receive a standard inferior alveolar nerve block injection. After endodontic treatment, patients will be given postoperative instructions and informed, in case of pain, to receive ibuprofen 200 mg as rescue medication.
Postendodontic pain intensity and incidence at the different pain categories (No, mild, moderate, severe) will be assessed 6, 12, 24, 48, 72 hours and 7 days postoperatively using a 0-10 numerical rate scale (NRS). Analgesic intake throughout the 7 days will be recorded.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Vital Tooth
Keywords
Piroxicam, Postendodontic pain, analgesic intake
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment Type: Two arm, parallel, randomized clinical trial. Allocation ratio: 1:1 Framework: Superiority.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The study will be participant and operator-blind where the participant and operator will not know the intervention done.
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Piroxicam drug
Arm Type
Experimental
Arm Description
20 mg piroxicam
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
Piroxicam
Intervention Description
20mg piroxicam
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Postendodontic pain using a pain-measuring scale
Description
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
Time Frame
6 hours
Title
Postendodontic pain using a pain-measuring scale
Description
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
Time Frame
12 hours
Title
Postendodontic pain using a pain-measuring scale
Description
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
Time Frame
24 hours
Title
Postendodontic pain using a pain-measuring scale
Description
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
Time Frame
48 hours
Title
Postendodontic pain using a pain-measuring scale
Description
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
Time Frame
72 hours
Title
Postendodontic pain using a pain-measuring scale
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Analgesic medication intake incidence
Description
Analgesic medication intake incidence (Yes/No) as a rescue medication in case postoperative pain persisted after the sham medication intake.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asmaa FE Mhamed, B.D.S
Phone
+201273035494
Email
logainali89@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suzan AW Amin, Ph.D
Email
swaness@rocketmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asmaa FE Mohamed, B.D.S
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30820083
Citation
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.
Results Reference
background
PubMed Identifier
27563175
Citation
Joshi 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.
Results Reference
background
PubMed Identifier
14606784
Citation
Nekoofar 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.
Results Reference
background
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Piroxicam Premedication for Postendodontic Pain in Non-vital Mandibular Molars
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