Pain ControlPhase 2/3NCT00970112
Dexamethasone and Etoricoxib for Pain Prevention Following Periodontal Surgery
A Phase 2/3 study testing Open Flap Debridement in people with Pain Control, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Control
- What is being tested?
- Open Flap Debridement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2008to Mar 2010
- Phase
- Phase 2/3
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients presenting moderate or severe periodontitis after nonsurgical periodontal treatment with clinical signs of inflammation
Who cannot join
- Pregnant
- Diabetes mellitus
- Heart diseases
- Allergic to components of the medications
- Risk of endocarditis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: O Uso de Dexametasona e Etoricoxibe Para a prevenção e Controle da Dor pós-operatória após Cirurgia Periodontal
The purpose of this study is to investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery.
- Conditions
- Pain Control
- Being tested
- Open Flap Debridement
- Keywords
- pain, pain assessment
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Flap DebridementProcedure or surgery
Open flap debridement - access flap + scaling and root planning
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo 1 hour before surgery Receives: Procedure: Open Flap Debridement |
| Etoricoxib | Experimental | Etoricoxib 1 hour before surgery Receives: Procedure: Open Flap Debridement |
| Dexamethaone | Experimental | Dexamethasone 1 hour before surgery Receives: Procedure: Open Flap Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
hourly for the 8 first hours after surgery 3 times a day on the following 3 days
Measured: up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2009 (estimated)
- Study startNov 2008
- Primary completionSep 2009
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ControlStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual de Ponta Grossa
- Sponsor type
- University, hospital or other
- Investigators
- João Paulo Steffens, MSc Student, Principal investigator, UEPGFábio André Santos, PhD, Study director, UEPGGibson Luiz Pilatti, PhD, Study chair, UEPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00970112
- Sponsor's protocol ID
- 08169/08
- Other IDs
- 51/2008
- Status last verified
- Mar 2010
- First submitted
- 31 Aug 2009
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- O Uso de Dexametasona e Etoricoxibe Para a prevenção e Controle da Dor pós-operatória após Cirurgia Periodontal
- ClinicalTrials.gov ID
- NCT00970112
- Acronym / sponsor ID
- 08169/08
- Conditions
- Pain Control
- Keywords
- pain, pain assessment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universidade Estadual de Ponta GrossaUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 2 Sep 2009 (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 investigate whether preemptive medication with dexamethasone or etoricoxib provides better pain management and control than placebo following periodontal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Procedure: Open Flap DebridementPlacebo 1 hour before surgery |
| Etoricoxib | Experimental | Procedure: Open Flap DebridementEtoricoxib 1 hour before surgery |
| Dexamethaone | Experimental | Procedure: Open Flap DebridementDexamethasone 1 hour before surgery |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients presenting moderate or severe periodontitis after nonsurgical periodontal treatment with clinical signs of inflammation
Key exclusion criteria (5 listed)
- Pregnant
- Diabetes mellitus
- Heart diseases
- Allergic to components of the medications
- Risk of endocarditis
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 |
|---|---|---|
| Open Flap DebridementOpen flap debridement - access flap + scaling and root planning | Procedure or surgery | Dexamethaone, Etoricoxib, Placebo |
Primary outcome
pain
Time frame: up to 3 days
hourly for the 8 first hours after surgery 3 times a day on the following 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
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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.
João Paulo Steffens, MSc Student principal investigator
UEPG
Fábio André Santos, PhD study director
UEPG
Gibson Luiz Pilatti, PhD study chair
UEPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Open Flap Debridement in people with Pain Control, run by Universidade Estadual de Ponta Grossa at 1 site in Brazil.
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 1 inclusion and 5 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: finished, as of the sponsor's last update on 18 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: up to 3 days). 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 18 May 2010.