The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
Primary Purpose
Pulpitis, Pain Management
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Placebo
Tramadol
Novafen
Naproxen
Sponsored by
About this trial
This is an interventional treatment trial for Pulpitis focused on measuring Endodontics, pain, visual analogue scale, NSAIDs
Eligibility Criteria
Inclusion Criteria:
- The subjects were 20-60 years of age with no systemic diseases and females were not pregnant;
- No history of taking any analgesics or other drugs prior to presenting for treatment;
- Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth.
Exclusion Criteria:
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT01178203
First Posted
August 9, 2010
Last Updated
August 9, 2010
Sponsor
Azad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01178203
Brief Title
The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Azad University of Medical Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim: eliminating or reducing pain following endodontic treatment is of great importance. The aim of this study is to compare the effects of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis. Sample size: one hundred patients considering the inclusion and exclusion criteria were selected. Intervention and outcome: The effect of Tramadol, Novafen and Naproxen on post-operative pain following instrumentation of root canals in teeth with irreversible pulpitis was evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulpitis, Pain Management
Keywords
Endodontics, pain, visual analogue scale, NSAIDs
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Tramadol
Intervention Description
Tab, 100mg in 6, 12 and 24 hours after root canal treatment
Intervention Type
Drug
Intervention Name(s)
Novafen
Intervention Description
325 mg in 6, 12 and 24 hours after root canal treatment
Intervention Type
Drug
Intervention Name(s)
Naproxen
Intervention Description
Tab, 500 mg in 6, 12, and 24 hours after root canal treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Eligibility Criteria
Inclusion Criteria:
The subjects were 20-60 years of age with no systemic diseases and females were not pregnant;
No history of taking any analgesics or other drugs prior to presenting for treatment;
Patients had moderate to severe pain associated with irreversible pulpitis in single-rooted premolars or anterior teeth.
Exclusion Criteria:
12. IPD Sharing Statement
Learn more about this trial
The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
We'll reach out to this number within 24 hrs