PulpitisPhase 1/2NCT01178203
The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
A Phase 1/2 study testing Tramadol, Novafen and Naproxen in people with Pulpitis and Pain Management, run by Azad University of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Pulpitis, Pain Management
- What is being tested?
- Tramadol, Novafen and Naproxen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 2010to Aug 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
About this study
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.
- Conditions
- Pulpitis, Pain Management
- Being tested
- Placebo, Tramadol, Novafen, Naproxen
- Keywords
- Endodontics, pain, visual analogue scale, NSAIDs
- Medical subject headings
- Pulpitis, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo
TramadolDrug
Tab, 100mg in 6, 12 and 24 hours after root canal treatment
NovafenDrug
325 mg in 6, 12 and 24 hours after root canal treatment
NaproxenDrug
Tab, 500 mg in 6, 12, and 24 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Azad University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01178203
- Sponsor's protocol ID
- IAU-1083
- Status last verified
- Jul 2010
- First submitted
- 9 Aug 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Three Oral Medications on Post-operative Pain Following Endodontic Treatment
- ClinicalTrials.gov ID
- NCT01178203
- Acronym / sponsor ID
- IAU-1083
- Conditions
- Pulpitis, Pain Management
- Keywords
- Endodontics, pain, visual analogue scale, NSAIDs
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Azad University of Medical SciencesUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo | Drug | – |
| TramadolTab, 100mg in 6, 12 and 24 hours after root canal treatment | Drug | – |
| Novafen325 mg in 6, 12 and 24 hours after root canal treatment | Drug | – |
| NaproxenTab, 500 mg in 6, 12, and 24 hours after root canal treatment | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Tramadol, Novafen and Naproxen in people with Pulpitis and Pain Management, run by Azad University of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.