NCT01982799

Brief Summary

For patients with a toothache, is pain relief after root canal procedure improved using long acting local anesthetic and analgesics? The purpose of this clinical trial is the investigate the effect of long acting local anesthetic with 1 of 4 oral medication groups, on post-operative endodontic pain.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 13, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

November 3, 2016

Status Verified

November 1, 2016

Enrollment Period

1.6 years

First QC Date

October 31, 2013

Last Update Submit

November 2, 2016

Conditions

Odontalgia

Keywords

Endodontic treatment, analgesics, anesthesia, post-operative pain

Outcome Measures

Primary Outcomes (1)

  • Effect of long acting anesthesia and analgesics on endodontic pain

    Pain evaluation time points - pretreatment, after endodontic treatment, 2 hrs after analgesic dosing, following day

    36 hours

Secondary Outcomes (1)

  • Effect of gender and age on post-operative endodontic pain treatment

    36 hours

Study Arms (2)

Endododontic Tx + Long acting local anesthetic

EXPERIMENTAL

long acting local anesthetic

Drug: Oral placeboDrug: Oral ibuprofenDrug: oral naproxenDrug: oral acetaminophen/hydrocodone + ibuprofen

Endodontic Tx plus local anesthetic

EXPERIMENTAL

local anesthetic

Drug: Oral placeboDrug: Oral ibuprofenDrug: oral naproxenDrug: oral acetaminophen/hydrocodone + ibuprofen

Interventions

Oral placeboDRUG

placebo

Endododontic Tx + Long acting local anestheticEndodontic Tx plus local anesthetic
Oral ibuprofenDRUG

Ibuprofen

Endododontic Tx + Long acting local anestheticEndodontic Tx plus local anesthetic
oral naproxenDRUG

naproxen

Endododontic Tx + Long acting local anestheticEndodontic Tx plus local anesthetic
oral acetaminophen/hydrocodone + ibuprofenDRUG

vicodin/ibuprofen

Also known as: Vicodin plus ibuprofen
Endododontic Tx + Long acting local anestheticEndodontic Tx plus local anesthetic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • y.o. American Society of Anesthesiologists physical classification I or II Can understand and complete pain evaluation forms tooth pain (\>3 out of 10) needing root canal Ability to read and provide informed consent Must be able to swallow tablets

You may not qualify if:

  • Allergy/intolerance to analgesics (ibuprofen, naproxen, vicodin) Patients who are pregnant Patients currently on pain medications for an unrelated condition Patients unwilling to fill out pain scales Liver or kidney disease Unable to understand and complete consent form and pain evaluation forms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota School of Dentistry

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

ToothachePain, Postoperative

Interventions

IbuprofenNaproxenAcetaminophenHydrocodoneacetaminophen, hydrocodone drug combination

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesFacial PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsNaphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsAcetanilidesAnilidesAmidesAniline CompoundsAminesCodeineMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenes

Study Officials

  • Walter Bowles, DDS

    University of Minnesota

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 13, 2013

Study Start

February 1, 2014

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

November 3, 2016

Record last verified: 2016-11

Locations

US(1)