NCT00793052

Brief Summary

The purpose of this study is to determine whether Etodalac, Etoricoxib and Dexamethasone are effective for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Status
unknown

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 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 19, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 19, 2008

Status Verified

November 1, 2008

Enrollment Period

1.1 years

First QC Date

October 29, 2008

Last Update Submit

November 16, 2008

Conditions

TrismusEdemaPain

Keywords

trismusEdemapain

Outcome Measures

Primary Outcomes (1)

  • PAIN- By VAS graded from 1-10 TRISMUS- By MAX mouth opening from the first incisors adages POST OPERATIVE SWELLing - By measurement the distance between the Right and LEFT ear's tragus

    1 week

Study Arms (1)

A

EXPERIMENTAL
Drug: Etodalac, Etoricoxib and Dexamethasone

Interventions

Etodalac, Etoricoxib and DexamethasoneDRUG

Dexamethasone sodium phosphate 8 mg 1 hour before the extraction, 4 mg the day after the extraction and another 4 mg at second day to the extraction. Etoricoxib 120 mg 1 hour before the extraction, 120 mg the day after the extraction and another 120 mg at second day to the extraction. Etodalac 600 mg 1 hour before the extraction, 600 mg the day after the extraction and another 600 mg at second day to the extraction.

A

Eligibility Criteria

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

You may qualify if:

  • Patients who are refered for third molar extraction to our center
  • Must be able to swallow tablets

You may not qualify if:

  • Diabetes mellitus
  • Thyroid diseases
  • Cardiovascular diseases
  • renal diseases
  • hepatic diseases
  • respiratory system diseases
  • adrenal diseases
  • Allergy to Etodalac, Etoricoxib or Dexamethasone
  • Gastric ulcers
  • psychiatric diseases
  • Pregnant or breast feeding womans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

TrismusEdemaPain

Interventions

EtoricoxibDexamethasone

Condition Hierarchy (Ancestors)

SpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • benjamin Shlomi, DMD

    MAXILLOFACIAL SURGERY - TASMC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 29, 2008

First Posted

November 19, 2008

Study Start

November 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

November 19, 2008

Record last verified: 2008-11