NCT01178203

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1

Status
completed

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

Study Start

First participant enrolled

July 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
Last Updated

August 10, 2010

Status Verified

July 1, 2010

Enrollment Period

Same day

First QC Date

August 9, 2010

Last Update Submit

August 9, 2010

Conditions

PulpitisPain Management

Keywords

Endodonticspainvisual analogue scaleNSAIDs

Interventions

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

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PulpitisAgnosiaPain

Interventions

TramadolL 5409709Naproxen

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsDimethylaminesMethylaminesAminesLipidsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 10, 2010

Study Start

July 1, 2010

Primary Completion

July 1, 2010

Study Completion

August 1, 2010

Last Updated

August 10, 2010

Record last verified: 2010-07