TrismusNCT00793052
Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery
A study testing Etodalac, Etoricoxib and Dexamethasone in people with Trismus and Edema, run by Tel-Aviv Sourasky Medical Center.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Etodalac, Etoricoxib and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Dec 2009
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who are refered for third molar extraction to our center
- Must be able to swallow tablets
Who cannot join
- Diabetes mellitus
- Thyroid diseases
- Cardiovascular diseases
- renal diseases
- hepatic diseases
- respiratory system diseases
Show all 11Show fewer
- adrenal diseases
- Allergy to Etodalac, Etoricoxib or Dexamethasone
- Gastric ulcers
- psychiatric diseases
- Pregnant or breast feeding womans
About this study
Official title: Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery: A Prospective, Double-Blind Study
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
- Being tested
- Etodalac, Etoricoxib and Dexamethasone
- Keywords
- trismus, Edema, pain
- Medical subject headings
- Trismus, Edema, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: Etodalac, Etoricoxib and Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionDec 2009 (estimated)
- Study completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TrismusStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Investigators
- benjamin Shlomi, DMD, Study chair, MAXILLOFACIAL SURGERY - TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793052
- Sponsor's protocol ID
- TASMC-08-BS-062-CTIL
- Status last verified
- Nov 2008
- First submitted
- 29 Oct 2008
- Last updated
- 19 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etodalac, Etoricoxib and Dexamethasone for Prevention of Pain ,Swelling and Trismus Following Third Molar Surgery: A Prospective, Double-Blind Study
- ClinicalTrials.gov ID
- NCT00793052
- Acronym / sponsor ID
- TASMC-08-BS-062-CTIL
- Keywords
- trismus, Edema, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Nov 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2009 (estimated)
- First posted
- 19 Nov 2008 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Etodalac, Etoricoxib and Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are refered for third molar extraction to our center
- Must be able to swallow tablets
Key exclusion criteria (11 listed)
- Diabetes mellitus
- Thyroid diseases
- Cardiovascular diseases
- renal diseases
- hepatic diseases
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 |
|---|---|---|
| Etodalac, Etoricoxib and DexamethasoneDexamethasone 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. | Drug | A |
Primary outcome
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
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2008.
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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.
benjamin Shlomi, DMD study chair
MAXILLOFACIAL SURGERY - TASMC
Questions about this trial
What is this clinical trial studying?
A study testing Etodalac, Etoricoxib and Dexamethasone in people with Trismus and Edema, run by Tel-Aviv Sourasky Medical Center.
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 2 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 19 Nov 2008. 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.
Are results available for this study?
Results are not available in the source record.
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.
What does the primary outcome measure?
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 (time frame: 1 week). It is what the study was designed to measure, not a finding.
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 19 Nov 2008.