NCT02086097

Brief Summary

The purpose of this study is to investigate the analgesic efficacy of multiple doses of Dexketoprofen Trometamol 25 mg on postoperative pain following emergency endodontic treatment in teeth with irreversible pulpitis, using as control Ibuprofen 600 mg and a placebo group. Hypothesis: Dexketoprofen trometamol when administered in multiple doses produces a greater effect to control postoperative pain after treating symptomatic irreversible pulpitis; in patients undergoing pulpotomy as an emergency procedure

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2014

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

8 months

First QC Date

March 7, 2014

Last Update Submit

May 6, 2014

Conditions

Irreversible Pulpitis

Keywords

painsymptomatic irreversible pulpitispostoperative dental pain

Outcome Measures

Primary Outcomes (1)

  • post operative pain measurement in symptomatic irreversible pulpitis, after multiple doses of dexketoprofen trometamol

    Using a visual analogue scale, each patient is asked to inform the researcher team about postoperative pain levels at 1, 8, 16, 24, 48 and 72 hours after pulpotomy procedure as emergency clinical manage of endodontic pain in irreversible pulpitis cases. Patients will be asked to take multiple doses of either Dexketoprofen Trometamol 25mg, Ibuprofen 600mg or placebo pills. Also, aspects like local anesthetic effect duration and local/systemic side effects will be monitored. Each patient will have a personal file to record the information during each period (1, 8, 16, 24, 48 and 72 hours )

    1 observation after 72 hours of emergency clinical procedure (Pulpotomy) for pain management

Secondary Outcomes (1)

  • Duration of the activity of the analgesic treatment

    observation periods of 1, 8, 16, 24, 48 AND 72 hours

Study Arms (3)

dexketoprofen trometamol

EXPERIMENTAL

Administration of 25mg of Dexketoprofen Trometamol, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed

Drug: Dexketoprofen trometamol

IBUPROFEN

ACTIVE COMPARATOR

Administration of 600mg of Ibuprofen, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed

Drug: Ibuprofen

PLACEBO

PLACEBO COMPARATOR

4 doses of sugar pills, 1 pill right after clinical procedure, the other 3 every 8 until the 24 hours administration period is completed

Drug: PLACEBO

Interventions

Dexketoprofen trometamolDRUG

25m of dexketoprofen (oral intake) every 8 hours

Also known as: Miracox (Stein Labs), CODE: 00176101
dexketoprofen trometamol
IbuprofenDRUG

600 mg of Ibuprofen (Oral Intake) every 8 hours

Also known as: Ibuprofen Stein, CODE: 00065104
IBUPROFEN
PLACEBODRUG

INACTIVE SUGAR PILLS

Also known as: PLAC
PLACEBO

Eligibility Criteria

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

You may qualify if:

  • Subjects aged 18 years and older with moderate-to-severe dental pain assessed by numerical rating scale (NRS) associated with irreversible pulpitis.

You may not qualify if:

  • Female pregnant or breastfeeding
  • Used pain relievers or anti-inflammatory drugs within 24 hours preceding emergency endodontic treatment
  • Have any significant medical condition
  • Taking any medications for anxiety, depression or schizophrenia
  • Have a history of hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Endodontics Master Degree program, Dentistry Faculty, San Luis Potosi University

San Luis Potosí City, San Luis Potosí, 78290, Mexico

Location

MeSH Terms

Conditions

Pain

Interventions

dexketoprofen trometamolIbuprofen5'-palmitoyl cytarabine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Gisela Rodríguez, DDS

    Universidad Autonoma San Luis Potosi

    PRINCIPAL INVESTIGATOR

  • Amaury J Pozos-Guillen, PhD

    Universidad Autonoma San Luis Potosi

    STUDY CHAIR

  • Daniel Chavarria, PhD

    Universidad Autonoma San Luis Potosi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Basic Sciences Laboratory, Dentistry School

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 13, 2014

Study Start

August 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

May 7, 2014

Record last verified: 2014-05

Locations

ME(1)